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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 18.0-80.0, Chronic Obstructive Pulmonary Disease Compliance, Patient Quality of Life Patients to be started on Rolenium®, an inhaled combination of fluticasone propionate and salmeterol in doses (100 + 50) mcg, (250 + 50) mcg, (500 + 50) mcg administered via the Elpenhaler® Patients who should be diagnosed with severe COPD and FEV1 <60% of the expected normal rate and a history of repeated exacerbations that have significant symptoms despite regular bronchodilator therapy: 1. Single LABA bronchoconstriction 2. Under dual bronchoconstriction LABA / LAMA 3. Never have received inhaled or systemic corticosteroids (ICS) 4. Previous ICS use in the past may be present, as long as the patient is not in the same treatment for the last three months Male or female patients over 18 years of age Compliance with treatment Compliance with study procedures Signed informed consent form Men or women under 18 years of age Non-compliance with treatment Inappropriate use of inhaled therapies Non-compliance in study procedures Unsigned patient consent
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0
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 20.0-75.0, Asthma non-smokers or former smokers (<10 pack/year) history of hypertension, or taking any prescribed medication for this disorder
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2
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 18.0-999.0, Asthma Aged 18 years or older at the time of consent History of airflow obstruction as indicated by a pre-bronchodilator forced expiratory volume in one second (FEV1) <80 percent predicted recorded in the previous 12 months Documented evidence of a reversibility assessment within the previous 12 months, which demonstrated a post-bronchodilator increase in FEV1 of >=12 percent and >= 200 milliliters (mL) Diagnosed with moderate or severe asthma as defined by a stable maintenance inhaled corticosteroid (ICS) dose for at least 12 weeks prior to screening of; moderate: medium ICS dose > 250 and <=500 micrograms per day (mcg/day) fluticasone propionate (or equivalent) based on the total daily maintenance treatment dose; Severe: high ICS dose > 500 mcg/day fluticasone propionate (or equivalent) based on the total daily maintenance treatment dose Documented control status defined using the asthma control questionnaire (ACQ-6) items (ACQ-6) obtained at the time of screening Able to understand, read and speak English or Spanish sufficiently to complete all assessments Willing and able to take part in a telephone interview session Willing and able to provide written informed consent Is a current smoker Has any medical condition that would preclude participation in this study, including the presence of emphysema or chronic bronchitis (COPD other than asthma) or a clinically important lung condition other than asthma such as current infection, bronchiectasis, pulmonary fibrosis, bronchopulmonary aspergillosis or diagnoses of an eosinophilic disorder such as eosinophilic esophagitis or a history of lung cancer Participated in an interventional study within the past 30 days
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2
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 18.0-999.0, Asthma Screening Capable of giving signed informed consent Male or female subjects aged >= 18 years of age at Screening (Visit 1). A female subject is eligible to participate if she is not pregnant not breastfeeding, and at least one of the following conditions applies; Not a woman of childbearing potential (WOCBP); A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for the duration of the study A diagnosis of persistent asthma for at least 12 weeks prior to Screening (Visit 1) All subjects must be using an ICS with or without LABA for at least 12 Weeks prior to Visit 1. Two populations are eligible for enrolment: Subjects maintained on a stable ICS low to medium-dose fluticasone propionate 100 to 250 mcg twice daily or equivalent for at least 4 weeks prior to Visit 1; Subjects maintained on a stable dose of an ICS/LABA low-dose combination product (e.g., 100/50 mcg twice daily or equivalent, via other combination products or via separate inhalers) for at least 4 weeks prior to Visit 1 Subjects must have a best pre-bronchodilator FEV1 of 50% of their predicted normal value. Predicted values will be based upon Global Lung Function Initiative (GLI) equations for spirometry reference values Subjects must demonstrate >=12% and 200 milliliter reversibility of FEV1 within 10 to 40 minutes following 4 inhalations of albuterol/salbutamol inhalation aerosol (or an equivalent nebulized treatment with albuterol/salbutamol solution) at Visit 1. Subjects that have documented reversibility meeting the above within the last 6 months prior to Visit 1 (Screening) will be eligible and do not need to repeat the reversibility assessment at Visit 1 (Screening). Reversibility measurements, including historical reversibility, should follow/meet the recommendations of the American Thoracic Society (ATS)/ European Respiratory Society (ERS) Task force: Standardization of Lung Function Testing All subjects must be able to replace their current short-acting bronchodilator (SABA), or other reliever strategy, with albuterol/salbutamol at Visit 1 (Screening), to be used only on an as-needed basis for the duration of the study. Each subject must be judged capable of withholding albuterol/salbutamol for at least 6 hours prior to performing spirometric evaluations Subjects must be able to read and complete the questionnaire and electronic daily diary themselves. Screening Defined for this protocol as an asthma episode that required intubation and/or was associated with hypercapnia, respiratory arrest or hypoxic seizures within the last 5 years An asthma exacerbation requiring systemic corticosteroids within 12 weeks prior to Visit 1. Any exacerbation requiring overnight hospitalization requiring additional treatment for asthma within 6 months prior to Visit 1 Current tobacco smoker or has a smoking history of >=10 pack-years (20 cigarettes/day for 10 years) Culture-documented or suspected bacterial or viral infection of the upper or lower respiratory tract, sinus or middle ear that is not resolved within 4 weeks of Visit 1 and led to a change in asthma management or, in the opinion of the investigator, is expected to affect the subject's asthma status or the subject's ability to participate in the study Women who are pregnant or lactating or are planning on becoming pregnant during the study A subject must not have current evidence of: Atelectasis segmental or larger; Bronchopulmonary dysplasia; Chronic bronchitis; Chronic obstructive pulmonary disease (COPD) current or past diagnosis including asthma/COPD overlap; Pneumonia; Pneumothorax; Interstitial lung disease or any evidence of concurrent respiratory disease other than asthma A subject must not have any clinically significant, uncontrolled condition, or disease state that, in the opinion of the investigator, would put the safety of the participant at risk through study participation or would confound the interpretation of the efficacy results if the condition/disease exacerbated during the study A subject must not have used any investigational drug within 30 days prior to Visit 1 or within five half-lives (t1/2) of the prior investigational study, whichever is longer of the two periods Any adverse reaction including immediate or delayed hypersensitivity to any beta2-agonist, sympathomimetic drug, or any intranasal, inhaled, or systemic corticosteroid therapy, or excipients used with fluticasone furoate/vilanterol 100/25 or fluticasone furoate 100 (i.e., drug, lactose or magnesium stearate)
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1
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 18.0-75.0, Cough Cough Variant Asthma Upper-Airway Cough Syndrome GERD Allergic Rhinitis Adults patients aged between 18 and 75; 2. Chronic cough lasting more than 8 weeks; 3. Non-smoking (min. 6 months); 4. Not treated with angiotensin-converting enzyme (ACE) inhibitors; 5. Not treated with: 1. inhaled corticosteroids or systemic corticosteroids min. 4 weeks before enrolment, 2. proton pump inhibitors min. 2 weeks before enrolment, 3. antihistaminic drugs 1 week before enrolment; 6. With normal chest radiograph or with insignificant changes in cough pathogenesis 7. Without airway infection in previous 6 weeks. 8. Patients enrolled with informed consent Patients under 18 years old and above 75 years old; 2. Smokers (actual or ex-smokers shorter than 6 weeks); 3. Therapy with corticosteroids (inhaled or systemic) for last 4 weeks, proton pump inhibitors for 2 weeks, antihistaminic drug for 1 week before enrolment; 4. Airway infection 6 weeks preceding enrolment or during study re-attempt to enroll after 6 weeks
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0
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 12.0-75.0, Asthma Male or female subjects at least aged ≥12 years old. 2. Known history of moderate to severe persistent, reversible asthma for ≥ 6 months prior to the Screening Visit characterized by inadequate asthma control on treatment with an ICS alone OR controlled asthma on treatment with an ICS-LABA combination. 3. Demonstrated a pre-dose FEV1 of ≥ 40% to ≤ 80% for predicted normal values during the Screening Visit (Visit 1) following appropriate withholding of asthma medications (if applicable) No LABA use within 12 hours and/or no SABA use within 6 hours of the PFT No SAMA (e.g., ipratropium) use within 8 hours and/or no LAMA (e.g., tiotropium) use within 72 hours of the PFT No use of inhaled ICS-LABA combination asthma therapy within 12 hours of the PFT Inhaled corticosteroids are allowed on the day of screening Oral Aminophylline should be withheld for at least 24 hours prior to the PFT. 4. Documented FEV1 reversibility of ≥ 12% (plus ≥ 200ml if the subject is older than 18 years old) within last 12 months which could be accepted by the investigator, or during the screening phase or at Visit 2. 5. Demonstrated satisfactory technique in the use of the study medication. 6. Females of child bearing potential or less than one year post-menopausal must have a negative serum pregnancy test recorded at the screening visit and a negative urine pregnancy test result prior to the first dose of study medication, be non-lactating, and willing to use adequate and highly effective methods of contraception throughout the study. A highly effective method of birth control is defined as those which result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly such as sterilisation, implants, injectables, combined oral contraceptives, some IUDs (Intrauterine Device, hormonal), sexual abstinence or vasectomised partner. 7. Willing and able to enter information in the diary and attend all study visits. 8. Willing and able to substitute study medication for their pre-study prescribed asthma medication for the duration of the study. 9. Written informed consent obtained, for <18 years old subjects, both parental consent and subjects assent are needed. Besides The Inclusion/ Checking, Additional Randomisation Required Following Run-In Period: 1. Demonstrated a pre-dose FEV1 of ≥ 40% to ≤ 80% for predicted normal values at Randomisation Visit (Visit 3) following appropriate withholding of asthma medications (if applicable). 2. ACQ score at Visit 3 ≥ 1.0. 3. Subjects with a good compliance with treatment or patient dairy. The definition of good compliance is that the completeness of diary during the last 14 days of the run-in period is at least 80%. The compliance on diary completeness will be assessed from the aspects below and agreed by the investigator and study Medical Monitor: 1. Diary info has been filled out on ≥80% of the days during the last 14 days before randomization (e.g., at least 11 days with diary filled completed out of the last 14 days prior to randomization). 2. 80% main items including the study endpoints related ones have been filled out within the last 14 days prior to randomization. 3. No other significant incompliance judged by the investigator that indicates the potential future incompliance for critical data collection during the study treatment period The adolescent subjects (age ≥ 12 years to <18 years) who are on ICS alone at a dose >250μg bid fluticasone or equivalent OR ICS-LABA combination at a dose of Seretide > 250/50 μg bid or equivalent. 2. Near fatal or life-threatening (including intubation) asthma within the past year. 3. Chest X-ray at the Investigator's discretion from clinical perspective that reveals evidence of clinically significant abnormalities not believed to be due to asthma. 4. Hospitalization or an emergency visit for asthma within the 4 weeks before the screening visit or during the screening visit. 5. Use of systemic (injectable or oral) corticosteroid medication within 1 month of the Screening Visit. 6. Omalizumab use within the past 6 months prior to the Screening Visit. 7. Current evidence or known history of any clinically significant disease or abnormality including uncontrolled coronary artery disease, congestive heart failure, myocardial infarction, or cardiac dysrhythmia. 'Clinically significant' is defined as any disease that, in the opinion of the Investigator, would put the subject at risk through study participation, or which would affect the outcome of the study. 8. In the investigator's opinion a clinically significant upper or lower respiratory infection within 4 weeks prior to the Screening Visit. 9. Significant, non-reversible, active pulmonary disease (e.g., chronic obstructive pulmonary disease (COPD), cystic fibrosis, bronchiectasis, tuberculosis). 10. Subject has a smoking history equivalent to ≥ 10 pack years (i.e., at least 1 pack of 20 cigarettes /day for 10 years or 10 packs/day for 1 year, etc.) or significant history of exposure to biomass fuel combustion which may be considered a plausible contributory cause to the subject's obstructive lung disease. 11. Current smoking history within 12 months prior to the Screening Visit. 12. Current evidence or known history of alcohol and/or substance abuse within 12 months prior to the Screening Visit. 13. Subject has taken B-blocking agents, tricyclic antidepressants, monoamine oxidase inhibitors, astemizole (Hismanal), quinidine type antiarrhythmics, or potent CYP 3A4 inhibitors such as ketoconazole within the past week. 14. Current use of medications other than those allowed in the protocol that will have an effect on bronchospasm and/or pulmonary function. 15. Current evidence or known history of hypersensitivity or contraindications to the investigational products or components, including the history of paradoxical bronchospasm after inhalation therapy as immediate increase in wheezing and shortness of breath. 16. Subject has received an investigational drug within 30 days of the Screening Visit (12 weeks if an oral or injectable steroid). 17. Subject is currently participating in another clinical study or has already been randomized in this study. 18. Mental incapacity, unwillingness, or language barrier precluding adequate understanding, cooperation or any factors might block patients from protocol defined visits and may impact the patient diary completion at the Investigator's discretion
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1
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 18.0-999.0, Bronchial Asthma Patients who have signed informed consent form before initiation of any study related procedure. 2. Male or female patients who are ≥18 years of age at the time informed consent is obtained. 3. Documented diagnosis of asthma as defined by the National Asthma Education and Prevention Program (NAEPP) and diagnosed at least 12 weeks prior to screening. 4. Patients with pre-bronchodilator forced expiratory volume in one second (FEV1) of 40% to 85% (both inclusive) of the predicted normal value at the Screening Visit V2. 5. Patients who demonstrated an increase of ≥15% of FEV1 within 15 30 minutes following administration of albuterol at Screening Visit V2 6. Patients who are stable on current asthma treatment for at least 4 weeks prior to Screening Visit V1. 7. Patients who are able to discontinue their current asthma medications (if any) and any other prohibited medications throughout the study, per the protocol list of prohibited medications during study participation (see Section 6.3.2). 8. Patients who are able to replace their current short-acting beta 2 agonist (SABA) inhaler with the study provided albuterol inhaler to be used as rescue medicine (as needed) throughout the study. Patients who are able to withhold SABAs for at least 6 hours prior to lung function assessments on study visits. 9. Patient who are non-smokers or ex-smokers; and have had ≤10 pack years 10. Patients who have not inhaled tobacco or consumed other tobacco containing products have not inhaled vaping products, drugs of abuse, or inhaled marijuana for at least 12 months prior to screening. 11. Women of childbearing potential (WOCBP) must not be lactating or pregnant at screening, as documented by a negative screening pregnancy test 12. Women of childbearing potential must commit to consistent and correct use of an acceptable method of birth control (at the investigator's discretion) throughout the study History of life-threatening asthma defined as an asthma episode(s) that required intubation and/or was associated with hypercapnic, respiratory arrest, or hypoxic seizures, asthma related syncopal episode(s) within the past one year. 2. History of any asthma-related hospitalizations within the past one year. 3. Any asthma exacerbation requiring emergency room (ER) visits or systemic (including oral) corticosteroids within 2 months prior to signing the consent. 4. Evidence or history of clinically significant disease or abnormality including congestive heart failure, uncontrolled hypertension, uncontrolled coronary artery disease, myocardial infarction, or cardiac dysrhythmia (prolonged QT interval as judged by the investigator). In addition, historical or current evidence of significant hematologic, hepatic neurologic, psychiatric, renal, or other diseases that in the opinion of the investigator, would put the patient at risk through study participation, or would affect the study analyses if the disease exacerbated during the study. 5. Patients with uncontrolled allergic rhinitis. 6. Clinical visual evidence of oral candidiasis. 7. History of any adverse reaction; known hypersensitivity to any sympathomimetic drug 8. Use of medication(s) with potential to affect the course of asthma or to interact with sympathomimetic amines throughout the study period. 9. Recent viral or bacterial infection or infection of the upper or lower respiratory tract, sinus, or middle ear that is not resolved within 4 weeks of screening. 10. Patients, who in the opinion of the investigator, significantly abuse alcohol or drugs will be excluded. 11. Use of systemic (including oral) corticosteroids within 4 weeks or intramuscular depot corticosteroid treatment 90 days prior to screening for any reason other than asthma (see #3 above). 12. Patients taking any immunosuppressive medications within 4 weeks prior to screening and during the study. 13. Factors (e.g., infirmity, disability, geographic location) that the investigator felt would likely limit the patients' compliance with the study protocol or scheduled clinic visits. 14. Use of any investigational drug (approved or unapproved) within 30 days 15. Study participation by clinical investigator site employees and/or their immediate relatives. 16. Patients who are unable to produce valid and reproducible spirometry per American Thoracic Society/European Respiratory Society (ATS/ERS) standards at the screening visit or unable to use the electronic diary (e diary). 17. Patients unable to use the inhalation powder device adequately
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1
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 18.0-999.0, Utilization of Medical Care by Nursing Home Residents Residents at least one GP visit in recent three months or two GP visits in recent 6 months or admission to the nursing home during the precedent 6 months independently of documented GP contacts at least 18 years of age written informed consent by the resident or her/his legal guardian Nursing Homes minimum size of 40 residents written consent provided by the nursing home Manager Prior to randomisation Residents admission for short term care only Nursing Homes participation in other projects on interprofessional collaboration
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0
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 18.0-65.0, Rhinitis, Allergic Healthy, ambulatory male and female subjects between 18 to 65 years of age Self-reported seasonal allergic rhinitis to ragweed pollen for at least 2 years prior to screening Documented positive skin prick test response to common ragweed (ambrosia artemisiifolia) pollen at screening or within the previous 12 months conducted at research site (prick with wheal diameter >= 5 mm larger than the diluent response) In order to qualify to continue to treatment phase, at the end of priming phase (which is 3 hours), Total Symptom Score (TSS) has to be ≥ 7, with nasal congestion score alone ≥ 2 and change in peak nasal inspiratory flow (PNIF) has to be ≥ 15% from pre-prime baseline Subject is willing to stop use of current decongestant and allergy medications at the start of the washout period prior to priming and during the trial At the discretion of the investigators, subjects may be considered with self-reported mild intermittent asthma (Using <=2 doses of SABA (short-acting beta agonists) per week) or exercise-induced asthma Subject is free of any clinically significant disease that required a physician´s care and/or would interfere with trial evaluations, procedures or participation Subject is able to repeatedly and reliably perform PNIF measurements and must achieve PNIF value of >=60L/min at screening Subject must be capable of reading English and willing to participate in all aspects of the study Any significant medical condition which, in the judgment of the investigator, is a contraindication to the use of loratadine, pseudoephedrine and fluticasone propionate, or might interfere with the trial. These may subjects with injury or surgery to the nose that is not fully healed, fungal infections, immunocompromised conditions (HIV, tuberculosis), severe nosebleeds, narrow-angle glaucoma, chickenpox measles..., severe facial pain or thick nasal discharge, sinusitis, constant whistling sound from the nose, structured abnormality of the nose, uncontrolled thyroid disease (e.g., hyperthyroidism, hypothyroidism), uncontrolled diabetes mellitus, coronary heart disease ischemic heart disease, uncontrolled high blood pressure, symptomatic prostatic hypertrophy, bladder neck obstruction, hepatic insufficiency, renal disease
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0
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 19.0-89.0, Osteoarthritis, Knee Diagnosis of symptomatic primary knee osteoarthritis according to the American Rheumatism Association classification for knee osteoarthritis, ability to understand study protocol and agreement to participate History of any knee injection in the past 6 months, History of more than 2 injections in the knee under study, previous fracture or surgical procedure of knee under investigation, any benign or malignant tumor in knee, chemotherapy, hemearthosis, current infection in the affected limb
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0
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 65.0-130.0, Asthma COPD Patients with a diagnosis of COPD or Asthma, medicated with any kind of inhaler device (pressurized Metered Dose Inhaler (pMDI) with or without Spacer, Dry Powder Inhaler (DPI) or Soft Mist), aged ≥65 years and being a regular user of primary health care services (defined as having at least one consultation performed in the last two years with his/her own Family Doctor). In order to minimize diagnostic inaccuracy, Asthma and COPD diagnosis will be reviewed in every participant at baseline prior to enrolment and according to GINA and GOLD strategies Severe or acute illness (such as unstable cardiovascular status, unstable angina, recent myocardial infarction (within one month) or pulmonary embolism, haemoptysis of unknown origin, recent pneumothorax (within one month), recent thoracic, abdominal or eye surgery (within one month), acute nausea or vomiting, severe respiratory distress, dementia). Patients with intermittent asthma, as well as COPD patients with mild obstruction (GOLD class I) will be excluded, since these patients do not need to take inhaler medication on a daily basis, and tend to have a low frequency of disease exacerbations
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0
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 21.0-999.0, Heart Failure Subjects either hospitalized for decompensated systolic, diastolic, or combined heart failure or subjects presenting at an outpatient clinic with a history of hospital discharge for decompensated systolic, diastolic, or combined heart failure within the previous 10 days All subjects must be 21 years of age or older on the day of screening Subjects who are wearing the wearable cardioverter defibrillator (WCD) Subjects not expected to survive one year from enrollment from non-cardiac disease Subjects with skin allergy or sensitivity to medical adhesives Subjects anticipated to start dialysis within 90 days Subjects currently implanted with an S-ICD system Subjects whose primary diagnosis on hospital admission was Acute Coronary Syndrome (ACS) STEMI/NSTEMI rather than heart failure exacerbation Subjects who are unable to participate in all follow up visits Subjects participating in any other research at time of enrollment Subjects currently implanted with an LVAD
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0
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 18.0-70.0, Overweight and Obesity Body mass index (BMI) between 25-45 kg/meters-squared one or more cardiovascular risk factor (type 2 diabetes, hypercholesterolemia, or hypertension) currently in another active weight loss program taking weight loss medication currently pregnant, lactating <6 months post-partum plan to become pregnant during the next 12 months a medical condition that would affect the safety of participating in unsupervised physical activity inability to walk 2 blocks without stopping
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0
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 16.0-75.0, Asthma Chronic diagnosis of asthma, based on a history of episodic dyspnea and wheezing, and/or documented bronchodilator reversibility in forced expiratory volume in 1 s (FEV1) of 12% and 200 ml according to the National Institutes of Health criteria; 2. to be non or ex-smoker of less than 10 pack-yr, 3. to be neither pregnant nor breast-feeding 4. to be capable of completing Asthma control test and spirometry. - Any other pulmonary disorder than asthma. Illiteracy. -
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2
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 13.0-999.0, Asthma Adolescents who are at least 13.0 at the time of consent Teenager reports having a prior asthma diagnosis, and in the last 12 months has: (a) used prescribed asthma medication and (b) uncontrolled asthma, defined as: (i) symptoms 3+ days a week; (ii) night awakenings 3+ nights per month; (iii) 2+ ED visits; or (iv) 1+ hospitalization for asthma; and Adolescents are English proficient • Co-morbid diseases that affect lung functioning
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1
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 18.0-50.0, Cystic Fibrosis Bronchiectasis Healthy subject, ages 18 Non-ambulatory, diagnosed neuromuscular disorder, currently using any type of oscillation vest therapy, diagnosed co-morbid condition (i.e. lung cancer, other lung disorder or disease), currently enrolled in a medical research study, non-English speaking
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0
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 18.0-65.0, Cough Variant Asthma age 18-65 years old. Cough as the sole or predominant symptom lasting for at least 8 weeks, with no radiographic evidence of lung diseases treatment of any oral corticosteroid in the last 4 weeks, and respiratory tract infection within 8 weeks. smoking (min. 6 months) had asthma or other lung diseases, including obliterative bronchiolitis, bronchiectasis,and cystic fibrosis
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1
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 22.0-999.0, Muscle Tightness Voluntarily signed informed consent form BMI ≤ 30 kg/m2 Women of child-bearing potential are required to use birth control measures during the whole duration of the study Subjects willing and able to abstain from partaking in any treatments other than the study procedure to promote body contouring during study participation Subjects willing and able to maintain his/her regular (pre-procedure) diet and exercise regimen without effecting significant change in either direction during study participation Cardiac pacemakers Electronic implants Pulmonary insufficiency Metal implants Drug pumps Haemorrhagic conditions Anticoagulation therapy Heart disorders Malignant tumor Fever
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0
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 22.0-999.0, Muscle Tightness Voluntarily signed informed consent form BMI ≤ 30 kg/m2 Women of child-bearing potential are required to use birth control measures during the whole duration of the study Subjects willing and able to abstain from partaking in any treatments other than the study procedure to promote body contouring during study participation Subjects willing and able to maintain his/her regular (pre-procedure) diet and exercise regimen without effecting significant change in either direction during study participation Cardiac pacemakers Electronic implants Pulmonary insufficiency Metal implants Drug pumps Haemorrhagic conditions Anticoagulation therapy Heart disorders Malignant tumor Fever
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0
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 12.0-999.0, Severe Asthma Patients aged 12 years or older Patients with confirmed diagnosis of severe asthma Patients receiving treatment according to GINA step 5 or uncontrolled for 4 step. Uncontrolled patients are defined as having symptoms of severe asthma or frequent exacerbations Signed informed consent Patients currently participating in clinical trials at the time of enrolment Intermittent, mild, moderate BA, before verification of the diagnosis COPD Diseases of the respiratory system, such as tuberculosis, sarcoidosis, IPF, lung cancer Vasculitis, systemic connective tissue diseases Neoplasm Written refusal of the patient to participate in the study after signing an informed consent
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2
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 18.0-50.0, Cystic Fibrosis Bronchiectasis Healthy subject, ages 18 Non-ambulatory diagnosed neuromuscular disorder currently using any type of oscillation vest therapy diagnosed co-morbid condition (i.e. lung cancer, other lung disorder or disease) currently enrolled in a medical research study non-English speaking presence of the following active implantable devices: pacemakers, neurostimulators, infusion pumps, circulatory support devices, implantable cardioverter defibrillators (ICD's), cochlear implants presence of head and/or neck injury that has not yet been stabilized presence of active hemorrhage with hemodynamic instability
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0
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 18.0-69.0, Asthma Inflammation Patient Relations, Nurse Spirometry Non-smokers or those who stopped smoking more than five years ago Age between 18-69 years Be legally capable Response to the short-acting bronchodilator FEV1> 12% and> 200 mL Absence of upper airway infection during 30 days and associated systemic diseases Smokers Over 70 years old Airway infection Legally incapable persons Diseases that may affect respiratory function
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 18.0-999.0, Colorectal Adenoma Colorectal Neoplasm Colorectal Cancer Obesity Metabolic Syndrome Non-Alcoholic Fatty Liver Disease Liver Fibrosis Aged 18 years and over 2. Able to give informed consent 3. Indications: 1. Patients with positive faecal occult blood test (FOBt) referred for index colonoscopy as part of Bowel Cancer Screening Programme 2. Colonoscopy conversion from Bowelscope 3. Index diagnostic colonoscopy due to new gastrointestinal symptoms (including but not restricted to diarrhoea, change in bowel habit, abdominal pain, PR bleeding, weight loss), iron deficiency anaemia, family history of CRC, abnormal findings on cross sectional imaging Absolute contraindication to colonoscopy 2. Unable to give informed consent 3. Known colorectal cancer 4. Known polyposis syndrome 5. Previous total/subtotal colectomy 6. Known colonic stricture which would prevent completion of colonoscopy 7. Attending for therapeutic procedure 8. Attending for assessment of a known lesion 9. Attending for assessment of known inflammatory bowel disease (IBD) 10. Attending for surveillance colonoscopy (polyp surveillance, post colorectal cancer surveillance, IBD surveillance) 11. Colonoscopy within the last 5 years
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0
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 18.0-60.0, Occupational Exposure Workers in flour mills
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0
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 12.0-65.0, Asthma Ages 12-65 2. Ability to provide informed consent 3. Ability to perform pulmonary function tests 4. Female subjects of childbearing potential must have a negative urine pregnancy test upon study entry . 5. Female subjects with reproductive potential must agree to use FDA approved methods of birth control for the duration of the study. 6. Clinically stable asthma at time of entry 7. Participant reported Physician or Licensed Medical Practitioner Diagnosis of Asthma 8. Treatment with medium to high dose ICS (400 mcg to maximum of 2000 mcq per day of fluticasone propionate or equivalent for at least 3 months with a stable dose ≥1 month prior to screening OR a biologic medication for asthma 9. History of asthma exacerbation in the past year, . An exacerbation is defined as: 1) a wheezing episode requiring treatment with systemic corticosteroid (oral, intravenous, or intramuscular) prescribed by a licensed medical providerand/or a biologic medication for asthma 2)An increase in >50% of baseline corticosteroid dose for ≥3 days 3.)An unscheduled visit for acute asthma/wheezing care (licensed medical practitioner/nurse office, urgent care intervention, emergency department, or hospitalization) Chronic lung disease other than asthma, which may impair lung function. 2. Current smoker or cessation of smoking within 6 months prior to Visit 1. 3. Comorbid disease that might interfere with the evaluation of the Investigational Product (Dupilumab). 4. Pregnancy 5. Other chronic pulmonary disorders associated with asthma-like symptoms, including (but not limited to) cystic fibrosis, chronic obstructive pulmonary disease, chronic bronchitis, vocal cord dysfunction (that is the sole cause of respiratory symptoms and at the PI's discretion), severe scoliosis or chest wall deformities that affect lung function, or congenital disorders of the lungs or airways 6. History of premature birth (before 34 weeks gestation) 7. The presence of clinically important co-morbidities. These uncontrolled diabetes, uncontrolled coronary artery disease, acute or chronic renal failure, and uncontrolled hypertension, hepatic or renal insufficiency, gastrointestinal disease, arrhythmia, malignancy, diverticulitis, immunodeficiency (including HIV), opportunistic infection, hepatitis, or any other condition or abnormality that in the opinion of the Principal Investigator would compromise the safety of the patient or quality of data 8. Evidence that the participant or family may be unreliable or poorly adherent to their asthma treatment or study procedures 9. Administration of a live vaccine within 6 weeks of screening. 10. Planning to relocate from the clinical center area before study completion 11. Any other that place the subject at unnecessary risk according to the judgment of the Principal Investigator and/or attending physician(s) of record. 12. Currently participating in an investigational drug trial 13. Being treated with immunosuppressive/immunodulatory or other investigational agents or biologics within 30 days or 5 half-lives of enrollment, whichever is longer 14. History of recent respiratory illness including asthma exacerbations in the past 4 weeks at screening requiring antibiotics or systemic corticosteroids. 15. History of alcohol or illicit substance abuse within 6 months of screening 16. Neutropenia (<1,000/mm3) or thrombocytopenia (<100,000/mm3) or hemoglobin < 100 g/L (10 g/dL) at screening 17. Subjects will be excluded if they have any serious medical problems and cannot perform study procedures. 1. Chronic lung disease other than asthma, which may impair lung function. 2. Current smoker or cessation of smoking < 6 months prior to Visit 1. 4. Pregnant or breast feeding 5. History of premature birth (before 34 weeks gestation) 6. Any other condition or abnormality that in the opinion of the Principal Investigator would compromise the safety of the patient or quality of data 7. Evidence that the participant or family may be unreliable or poorly adherent to their asthma treatment or study procedures 8. Administration of a live vaccine within 6 weeks of screening. 9. Planning to relocate from the clinical center area before study completion 10. Any other that place the subject at unnecessary risk according to the judgment of the Principal Investigator and/or attending physician(s) of record. 11. Currently participating in an investigational drug trial 12. Being treated with immunosuppressive/immunodulatory or other investigational agents or biologics for conditions other than asthma 13. History of recent respiratory illness including asthma exacerbations in the past 4 weeks at screening requiring antibiotics or systemic corticosteroids. 14. History of alcohol or illicit substance abuse within 6 months of screening 15. Neutropenia (<1,000/mm3) or thrombocytopenia (<100,000/mm3) or hemoglobin < 100 g/L (10 g/dL) at screening
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 18.0-999.0, COPD Asthma English or Spanish speaking At least 18 years of age Diagnosed with asthma or COPD Experiencing uncontrolled symptoms or exacerbations Do not plan to attend primary care clinic for at least 3 months Already engaged in pulmonary specialty care (defined as at least one visit in last 12 months) Cognitive dysfunction that would prevent interaction with a health coach Not having a phone at which the participant can be reached
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2
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 18.0-65.0, Smoking Cessation Hong Kong residents aged 18 to 65 years have used any tobacco products in the past month able to read and speak Chinese have not used NRT for the past month Have severe angina, serious cardiac arrhythmias and hypertension Have suffered from acute myocardial event in the past 4 weeks Pregnant nor breastfeeding Under medication and treatment due to mental illness One of the was "smoke 10 cigarettes or more per day in the past week" and is amended to "have used any tobacco products in the past month". The initial intention of setting the of at least 10 cigarettes per day (CPD) is to recruit smokers who have moderate to strong level of craving and a greater need for NRT. However, we also recognize that one of the objectives of the research is to promote the use of NRT for quit attempts with NRT sampling. In fact, smokers who smoke less than 10 CPD can also benefit from using NRT gums. Therefore, the change in the does not deviate from our research aim. In contrast, with the removal of the criterion for CPD, we will be able to reach out to a larger group of smoking population and encourage more smokers to use NRT to quit smoking
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0
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 18.0-999.0, Chronic Respiratory Disease Hypoxia, Altitude COPD ILD Cystic Fibrosis Age ≥18 years old (at the time of HAST) Clinically stable Hypoxic altitude simulation test, scheduled as part of the clinical care Inability to provide informed consent Being part of a clinical trial, which would patients who are taking part in other studies including observational studies
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0
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 18.0-999.0, Lung Function Testing Cigarette Smoking Single-photon Emission Computed Tomography (SPECT) Ventilation Homogeneity Lung Disease Prevention For Smokers group Active tobacco smoking of at least 10 cigarettes/day AND total smoking history of at least 15 pack-years Normal lung function testing, defined as: FVC/FEV1 ratio, FEV1 and FVC all greater than the lower limit of normal; mean forced expiratory flow at 25 to 75% of CVF (FEF25-75%) >80% of predicted value and absence of concavity on the forced expiratory flow curve, as evaluated by a trained respirologist; total lung capacity (TLC) greater than the lower limit of normal; residual volume (RV), functional residual capacity (FRC), expiratory reserve volume (ERV), inspiratory capacity (IC) and VR/TLC ratio all >80% predicted value and diffusion capacity of the lung for carbon monoxide (DLCO) >80% predicted value when corrected for hemoglobin level Body mass index (BMI) <30 kg/m2 • Post-bronchodilator change in FEV1 and FVC of more than 6% and/or 100 ml. For Non-smokers group No history of tobacco-smoking Normal lung function testing, defined as: FVC/FEV1 ratio, FEV1 and FVC all greater than the lower limit of normal; mean forced expiratory flow at 25 to 75% of CVF (FEF25-75%) >80% of predicted value and absence of concavity on the forced expiratory flow curve, as evaluated by a trained respirologist; total lung capacity (TLC) greater than the lower limit of normal; residual volume (RV), functional residual capacity (FRC), expiratory reserve volume (ERV), inspiratory capacity (IC) and VR/TLC ratio all >80% predicted value and diffusion capacity of the lung for carbon monoxide (DLCO) >80% predicted value when corrected for hemoglobin level Body mass index (BMI) <30 kg/m2 • Post-bronchodilator change in FEV1 and FVC of more than 6% and/or 100 ml
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0
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 7.0-11.0, Asthma on medium to high doses of steroids and/or leukotriene inhibitors a Child-Asthma Control Test Score <21 inability to speak English (child); inability to read/write English (parent/guardian) child hospitalized in past two weeks for their asthma current illness associated with oral temperature >100.4 pulse ox <95% and/or any wheezing, retractions or accessory muscle use
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1
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 18.0-999.0, Asthma Chronic Obstructive Pulmonary Disease Main 1. Male or female patients with asthma or COPD who have been using salmeterol/fluticasone propionate combination treatment for at least 3 months before the study 2. Age ≥18 years. 3. Written informed consent obtained. Main Pregnant or lactating female patients. 2. Participation in other clinical studies during the study. 3. Known hypersensitivity (allergy) to salmeterol, fluticasone propionate or the excipient lactose 4. Any significant medical disease or condition or other factor that might interfere with study assessments or study participation
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2
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 18.0-999.0, Asthma COPD Adherence, Medication Asthmatics with treatment ≥ GINA step 2 COPD-patients , GOLD stage II-IV No spirometry results available COPD patients not on long-acting bronchodilators
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2
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 18.0-999.0, Bronchial Asthma Pulmonary Healthy Controls known or suspected bronchial asthma known or suspected obstructive ventilation disorder pulmonary healthy controls pregnancy inability to participate
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2
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 18.0-65.0, Chronic Rhinosinusitis (Diagnosis) ALL these need to be positive Endoscopic nasal polyp score ≥4 SNOT-22 ≥30 Sinus Computed tomography Lund-Mackay score ≥14. The new sinus CT scans are needed if the previous sinus CT scans have been performed over 36 months before recruitment visit or if there is a suspicion of complication of CRS (f.ex. mucocele, invasive fungal rhinosinusitis) ≥1 previous partial/total ethmoidectomy surgery. In addition, patient should have a history of at least one of the following: >1 oral corticosteroids during the past two years >3 antibiotic courses during the past two years. In patients with contraindication/adverse effects in using oral steroids additional are not required complication of CRS (f.e. mucocele, invasive fungal rhinosinusitis) bleeding diathesis pregnancy/ breastfeeding cystic fibrosis primary ciliary dyskinesia (PCD) sarcoidosis granulomatosis with polyangitis (GPA) eosinophilic granulomatosis with polyangitis (EGPA) immunosuppression (diagnosed Spesific antibody deficiency (SAD), CVI, HIV use of biologicals/immunosuppressive medication
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0
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 12.0-80.0, Asthma Male or female subjects (between ≥ 12 and ≤ 80 years old). Females may be of either childbearing or non-childbearing potential. All females of childbearing potential must be either abstinent from sexual intercourse or using adequate contraception and must also have a negative pregnancy test. Pregnant or nursing females or females intending to become pregnant during the course of the study must be excluded from the study. 2. The subject has persistent asthma as defined by the National Asthma Education a Prevention Program (NAEPP ERP-3 (1)) at least 12 weeks prior to screening. 3. Pre-bronchodilator forced expiratory volume in 1 second (FEV1) on the screening visit and on the baseline visit is >40% of the predicted value according to age, height, race and sex using The global lung function 2012 equations: Report of the Global Lung Function Initiative (GLI), following abstinence from short-acting β-agonists for a minimum of 6 hours and withholding restricted medications prior to the visits. At Visit 2 the baseline FEV1 and the predicted FEV1 value would be the mean of 2 pre-dose FEV1 measurements taken 30 minutes apart (-30 min and 0). 4. The subject has demonstrated at least 12% reversibility of FEV1 at either the screening or baseline visit within 30 minutes after 4 inhalations (total of 360 μg) of albuterol (pMDI). [Note: Subjects who fail to demonstrate the required reversibility at the Screening Visit (Visit 1) are eligible to enter the Run-in Period and repeat the testing at the End of Run-in Period/Baseline (Visit 2)]. 5. If the subject is on inhaled corticosteroids the subject must be on a stable dose of daily-inhaled corticosteroid (ICS) at least 160 μg/day of beclomethasone dipropionate or equivalent for a minimum of 4 weeks before screening visit (Estimated comparative daily doses for ICSs for youths ≥12 years of age and adults per NAEPP ERP-3). 6. Currently nonsmoking; had not used tobacco products (i.e., cigarettes, cigars, pipe tobacco) within the past year, and had ≤ 10 pack years of historical use. 7. A body mass index between 18-35 kg/m2, inclusive. 8. Willingness to give their written informed consent/assent to participate in the study. 9. Subjects must be able to perform acceptable and repeatable spirometry, Peak Flow Meter (twice a day measurements), keep a diary record and to use the inhalation devices as assessed at Screening and Baseline by the study staff. 10. Ability to understand and comply with the protocol requirements, instructions and protocol stated restrictions. NOTE: At the end of the placebo Run-in period the subject will be stratified into two categories Corticosteroid naïve subjects (Not have taken inhaled corticosteroids (ICSs) at least 3 months prior to screening or systemic corticosteroids at least 6 months before screening) Prior corticosteroid users Incidence of asthma exacerbations per NAEPP ERP-3 within the last 3 months. 2. Respiratory diseases other than asthma or allergic rhinitis. 3. Uncontrolled asthma defined as having 3 of the following symptoms: a) Daytime asthma symptoms (> twice/week) b) Night waking due to asthma c) Reliever needed for symptoms more than twice a week (excluding reliever taken before exercise) d) Any activity limitation due to asthma per GINA, Chapter 2, Box 2-2, page 29. 4. Life threatening asthma, defined as a history of asthma episode(s) requiring intubation, and/or associated with hypercapnia; respiratory arrest or hypoxic seizures, asthma related syncopal episode(s) within the previous 10 years. 5. The known presence or history of tuberculosis infection of the respiratory tract; untreated systemic fungal, bacterial, parasitic or viral infections; or ocular herpes simplex. 6. The presence or history of clinically significant medical condition, other than asthma, including laboratory results abnormalities, that in the opinion of the investigator would put the subject at risk through study participation, or would affect the study analyses if the disease exacerbated during the study. Following conditions should be considered carefully: congestive heart failure, recent myocardial infarction, uncontrolled hypertension, cardiac arrhythmias and diabetes mellitus, epilepsy, glaucoma, cataract, uncontrolled hypothyroidism, liver failure, severe osteoporosis, peptic ulceration and renal impairment. 7. Hospitalization for asthma or a respiratory condition in the last 12 months. 8. Need for oral steroids or/and antibiotics for lung disease in last the 3 months. 9. Current or recent respiratory infection or current oral candida infection. 10. Participation in another clinical trial or study within 1 month or at least 5 half-lives (whichever is longer) preceding the first dose of trial medication. Previous participation in this study. 11. Use of any of the following excluded respiratory medications within the indicated time frame prior to screening and throughout the study: 1. Anti-IgE antibody (e.g. Xolair) and depot corticosteroids 3 months 2. Systemic (I.V., I.M., oral) corticosteroids 3 months 3. Inhaled corticosteroids Stop at screening 4. Long-acting anti-muscarinics (e.g., tiotropium) 48 hours 5. Short-acting anti-muscarinics (e.g., ipratropium) 24 hours 6. LABA (e.g., salmeterol, formoterol,etc.) 12 hours 7. Short-acting β2-adrenergic agonists (SABA), except for study rescue medication (albuterol) (see Section 4.7) 6 hours 8. Oral β2-adrenergic agonists 1 month 9. Topical dermatologic corticosteroids of intermediate to high potency such as fluticasone propionate, mometasone furoate 14 days 10. Oral or nasal antihistamines unless on a stable dose for 30 days prior screening. 11. Immunologically active biologic medications such as anti-TNFα (tumor necrosis factor) 3 months 12. Immunosuppressive therapy such as methotrexate, gold, Azathioprine 1 month 13. Immunotherapy initiation within 3 months or change in dose within 1 month 14. Over-the-counter bronchodilators 2 weeks 15. Marijuana 1 month 16. Inhaled nicotine such as e-cigarettes 1 day 12. Use of the following medications 30 days before screening: n. Non-cardioselective β-blockers (e.g. propranolol, nadolol, carvedilol, labetalol, sotalol) o. Digitalis p. Thiazide diuretics q. Oral decongestants r. Potent Cytochrome P450 3A4 enzyme inhibitors s. Benzodiazepines t. Cyclic antidepressants u. Monoamine oxidase inhibitors v. Diazoxide w. Ketoconazole, itraconazole x. Phenytoin y. Rifampicin z. Mifepristone 13. Known hypersensitivity to any corticosteroid or any of the excipients in the study drug or rescue medication formulation. 14. Evidence (as assessed by the Investigator using good clinical judgment) of alcohol or drug abuse or dependency at the time of screening, for the 6 months prior to screening. 15. Donation or loss of blood or plasma of one unit (about 450 mL whole blood or 220 mL plasma) in the previous 60 days. (Applicable for patients participating in PK arm of the study). 16. Lived in the same household as currently enrolled subject. 17. Any other reason which might, in the opinion of the Investigator, interfere with study evaluations or pose a risk to subject safety during the study
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1
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 18.0-70.0, Asthma, Bronchial Referred to the pulmonology department of the university hospital Basel because of suspected asthma defined as respiratory symptoms like wheezing or cough or chest tightness Asthma symptoms partly controlled according to GINA (Global Initiative for Asthma, October 2006) 1 week prior to randomization FEV1 ≥ 70% predicted Smoker and ex-smoker with >10 pack years COPD (chronic obstructive pulmonary disease) Upper respiratory tract infection within the past 4 weeks ICS or oral steroids during the previous month before beta-blockers within the past 4 weeks Current treatment with medication as defined in section concomitant medication (ICS other than study medication, ß-blockers) Pregnancy Known malignancy
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1
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 18.0-999.0, Best Possible Medication History Admission to Emergency Department of University Hospital Basel and transfer to medical ward medication history taken at Emergency Department of University Hospital Basel not present
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0
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 18.0-45.0, Airway Inflammation Age 18-45 years, inclusive, of both genders Negative pregnancy test for females who are not s/p hysterectomy with oophorectomy No history of episodic wheezing, chest tightness, or shortness of breath consistent with asthma, or physician-diagnosed asthma forced expiratory volume at one second (FEV1) of at least 80% of predicted and FEV1/forced vital capacity (FVC) ratio of >0.70 Oxygen saturation of >93% Ability to provide an induced sputum sample Subject must demonstrate a >10% increase in sputum %PMNs 6 hours following inhaled WSP exposure, when compared to baseline sputum (to be completed in a separate protocol IRB# 15-1775) Clinical contraindications Any chronic medical condition considered by the PI as a contraindication to the exposure study including significant cardiovascular disease, diabetes, chronic renal disease, chronic thyroid disease, history of chronic infections/immunodeficiency Viral upper respiratory tract infection within 4 weeks of challenge Any acute infection requiring antibiotics within 4 weeks of exposure or fever of unknown origin within 4 weeks of challenge Abnormal physical findings at the baseline visit, including but not limited to abnormalities on auscultation, temperature of 37.8° C, Systolic BP > 150mm Hg or < 85 mm Hg; or Diastolic BP > 90 mm Hg or < 50 mm Hg, or pulse oximetry saturation reading less than 93% Physician diagnosis of asthma If there is a history of allergic rhinitis, subjects must be asymptomatic of allergic rhinitis at the time of study enrollment Mental illness or history of drug or alcohol abuse that, in the opinion of the investigator, would interfere with the participant's ability to comply with study requirements Medications which may impact the results of the WSP exposure, interfere with any other medications potentially used in the study (to steroids, beta antagonists, non-steroidal anti-inflammatory agents) Cigarette smoking > 1 pack per month
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0
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 18.0-999.0, History of at Least One Coronal Dental Restoration Patient having read and signed the information letter attesting to his/her non-opposition Affiliated to a social security scheme Patient over 18 years old New patient in the practice or in the hospital service, that can be a classical odontalogical service or a consultation specializing in Gougerot Sjogren disease, with no history of a dental examination less than six months old, or Patient who has not consulted in the last six months Patient with at least one tooth with partial coronal restoration Patient under tutorship or curatorship
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0
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 18.0-65.0, Asthma Obesity Confirmed asthma as per Global Initiative for Asthma (GINA) guidelines 2015 with characteristic symptoms and at least one of the following: • Reversible airflow limitation and 200ml increase in forced expiratory volume (FEV1) in the preceding 5 years either: i. After inhaled/nebulised bronchodilator or 4+ weeks of anti-inflammatory treatment ii. Between visits • Positive bronchial challenge in the preceding 5 years: i. Provocation concentration (PC20) methacholine or histamine <8mg/ml ii. Provocative dose (PD15) mannitol <635mg 2. Difficult asthma defined as per Scottish Intercollegiate Guidelines Network (SIGN)/British Thoracic Society (BTS) guideline 2014 as persistent symptoms and/or frequent asthma attacks despite treatment at step 4 or step 5 with either ACQ6 >1.5 ≥2 systemic corticosteroid boosts in previous year ≥1 hospitalization in previous year 3. BMI ≥ 30 kg/m2 ICU admission +/ mechanical ventilation in the previous 6 months for asthma exacerbation 2. Respiratory tract infection requiring antibiotics or asthma exacerbation requiring corticosteroid boost in preceding 4 weeks 3. Significant respiratory or other co-morbidity likely to influence the conduct of the study 4. Pregnancy and breast feeding 5. Severe and/or unstable cardiac disease 6. Recent (within the preceding 6 months) commencement of antifungal, biologic (omalizumab, lebrikizumab, mepolizumab) or "Airsonett" device; eligible if on treatment for > 6months or discontinued 7. Current insulin use 8. Current treatment with anti-obesity drugs
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2
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 25.0-65.0, Asthma Under the care of a staff asthma physician (i.e. pulmonologist or allergist/immunologist) at NorthShore University HealthSystem (NS) Have an active NorthShore Connect (patient portal) account Persistent uncontrolled asthma in the past 12 months Active prescription for daily ICS medication for asthma candidate refusal the presence of other co-morbidities (e.g. severe psychiatric disorder) that could interfere with study participation
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2
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 18.0-45.0, Airway Inflammation Age 18-45 years, inclusive, of both genders Negative pregnancy test for females who are not s/p hysterectomy with oophorectomy No history of episodic wheezing, chest tightness, or shortness of breath consistent with asthma, or physician-diagnosed asthma Forced expiratory volume at one second (FEV1) of at least 80% of predicted and FEV1/ forced vital capacity (FVC) ≥0.70 Oxygen saturation of ≥93% Ability to provide an induced sputum sample Subject must demonstrate a ≥10% increase in sputum %PMNs 6 hours following inhaled WSP exposure, when compared to baseline sputum (to be completed in a separate protocol IRB# 15-1775) Clinical contraindications Any chronic medical condition considered by the PI as a contraindication to the exposure study including significant cardiovascular disease, diabetes, chronic renal disease, chronic thyroid disease, history of chronic infections/immunodeficiency Viral upper respiratory tract infection within 4 weeks of challenge Any acute infection requiring antibiotics within 4 weeks of exposure or fever of unknown origin within 4 weeks of challenge Abnormal physical findings at the baseline visit, including but not limited to abnormalities on auscultation, temperature of 37.8° C, Systolic BP > 150mm Hg or < 85 mm Hg; or Diastolic BP > 90 mm Hg or < 50 mm Hg, or pulse oximetry saturation reading less than 93% Physician diagnosis of asthma If there is a history of allergic rhinitis, subjects must be asymptomatic of allergic rhinitis at the time of study enrollment Mental illness or history of drug or alcohol abuse that, in the opinion of the investigator, would interfere with the participant's ability to comply with study requirements Medications which may impact the results of the WSP exposure, interfere with any other medications potentially used in the study (to steroids, beta antagonists, non-steroidal anti-inflammatory agents) Cigarette smoking > 1 pack per month
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0
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 18.0-999.0, Alcohol Use Disorder Alcohol Dependence Be at least 18 years of age. 2. Have a current (past 12 months) DSM-5 diagnosis of AUD (4 or more symptoms) assessed using the MINI neuropsychiatric interview version 7.0.2 (at least moderate severity, ICD-10-CM Code F10.20 alcohol dependence, uncomplicated). 3. Have a BAC by breathalyzer equal to 0.000 when s/he signed the informed consent document (either just prior to or immediately after signing consent). 4. Be seeking treatment for problems with alcohol reduction in drinking. 5. Be able to verbalize an understanding of the consent form, able to provide written informed consent, verbalize willingness to complete study procedures, able to understand written and oral instructions in English and able to complete the questionnaires required by the protocol. 6. Agree (if the subject is female and of child bearing potential) to use at least one of the following methods of birth control, unless she is surgically sterile, partner is surgically sterile or she is postmenopausal: 1. oral contraceptives, 2. contraceptive sponge, 3. patch, 4. double barrier (diaphragm/spermicidal or condom/spermicidal), 5. intrauterine contraceptive system, 6. etonogestrel implant, 7. medroxyprogesterone acetate contraceptive injection, 8. complete abstinence from sexual intercourse, and/or 9. hormonal vaginal contraceptive ring. 7. Be able to take intranasal investigational products and be willing to adhere to the investigational product regimen. 8. Complete all assessments required at screening and baseline. 9. Have a place to live in the 2 weeks prior to randomization and not be at risk that s/he will lose his/her housing by Study Week 14. 10. Not anticipate any significant problems with transportation arrangements or available time to travel to the study site by Study Week 14. 11. Not have any plans to move within Study Week 14 to a location which would make continued participation in the study impractical. 12. Not have any unresolved legal problems that could jeopardize continuation or completion of the study. 13. Provide contact information of someone, such as a family member, spouse, or significant other, who may be able to contact the subject in case of a missed clinic appointment. 14. Be someone who in the opinion of the investigator would be expected to complete the study protocol. 15. Agree to the schedule of visits, verbally acknowledge that s/he will be able to attend each scheduled visit, participate in phone visits and that s/he does not have any already scheduled events or a job that may substantially interfere with study participation. 16. If taking a medication for depression or anxiety, must have been taking a stable dose in the 2-months prior to randomization and plan to continue during the study. This includes drugs such as the following SSRIs Dual uptake inhibitors SNRIs Tricyclic antidepressants MAOIs Bupropion 17. Not currently taking oxytocin and agree not to take non-study oxytocin for the duration of the study Contact study site for
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0
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 4.0-17.0, Healthy Participant is between the ages of 4 years old at the time of consent Participant and/or family member/carer willing to give written consent Participant and/or family member/carer who can read and comprehend english Subject believed to be unsuitable for by the Principle Investigator Subject is pregnant at time of consent Subject is currently enrolled in another medical study
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0
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 20.0-40.0, Hamstring Tightness Males and females with age limit 20 to 40 years Active knee extension/90-90 test positive for Screening (With AKE range less than 160 degrees) No known history of hip joint or knee joint disease No history of recent hamstring strain History of sub-acute and chronic back pain of lumber region and SI joint in past 6 months Neurological pathology Patients with some kind of particularly specific pathology (e.g. infection, tumor, osteoporosis, lumbar spine fracture, structural deformity, inflammatory disorder)
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0
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 4.0-100.0, Asthma Legal guardians and or primary caregiver (18 years and older) of children 4-17 years of age Children/adolescents who have a diagnosis of asthma, and have documented poor control as evidenced by requiring two or more systemic steroids, one or more hospitalizations and/or two or more ED visits due to asthma in the 12 months prior to the asthma clinic or hospital visit Patients and caregivers will be English or Spanish speaking children < 4 yrs of age children with multiple chronic lung diseases Children and families whose primary language is other than English or Spanish
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1
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 18.0-65.0, Depression History of Suicide Attempt Being between 18 and 65 years old Meeting the DSM-5 for a current major depressive disorder For suicidal patients : having a lifetime history of suicide attempt For affective controls : having no personal history of suicide attempt Being able to understand the nature, purpose and methodology of the study Having signed the informed consent Being affiliated to a social security system Current depressive episode with psychotic characteristics Mental retardation or sever medical co-morbidity Lifetime Diagnosis of schizophrenia or schizoaffective disorder Current manic or hypomanic episode Sensory or cognitive disability Pregnant or breastfeeding woman Deprivation of liberty (by judicial or administrative decision) Protection by law (guardianship or curatorship) period in relation to another protocol Inability to understand, speak and write French
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0
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 1.0-31.0, B Acute Lymphoblastic Leukemia B Lymphoblastic Lymphoma Down Syndrome All B-ALL patients must be enrolled on APEC14B1 and consented to Screening (Part A) prior to treatment and enrollment on AALL1731. APEC 14B1 is not a requirement for B-LLy patients. B-LLy patients may directly enroll on AALL1731 Age at diagnosis Patients must be >= 365 days and < 10 years of age (B-ALL patients without DS) Patients must be >= 365 days and =< 31 years of age (B-ALL patients with DS) Patients must be >= 365 days and =< 31 years of age (B-LLy patients with or without DS) B-ALL patients without DS must have an initial white blood cell count < 50,000/uL (performed within 7 days prior to enrollment) B-ALL patients with DS are eligible regardless of the presenting white blood cell count (WBC) (performed within 7 days prior to enrollment) Patient has newly diagnosed B-cell ALL, with or without Down syndrome: > 25% blasts on a bone marrow (BM) aspirate OR if a BM aspirate is not obtained or is not diagnostic of B-ALL, the diagnosis can be established by a pathologic diagnosis of B-ALL on a BM biopsy OR a complete blood count (CBC) documenting the presence of at least 1,000/uL circulating leukemic cells Patient must not have secondary ALL that developed after treatment of a prior malignancy with cytotoxic chemotherapy. Note: patients with Down syndrome with a prior history of transient myeloproliferative disease (TMD) are not considered to have had a prior malignancy. They would therefore be eligible whether or not the TMD was treated with cytarabine With the exception of steroid pretreatment or the administration of intrathecal cytarabine, patients must not have received any prior cytotoxic chemotherapy for either the current diagnosis of B ALL or B LLy or for any cancer diagnosed prior to initiation of protocol therapy on AALL1731 For patients receiving steroid pretreatment, the following additional apply Non-DS B-ALL patients must not have received steroids for more than 24 hours in the 2 weeks prior to diagnosis without a CBC obtained within 3 days prior to initiation of the steroids DS and non-DS B-LLy patients must not have received > 48 hours of oral or IV steroids within 4 weeks of diagnosis Patients who have received > 72 hours of hydroxyurea B-ALL patients who do not have sufficient diagnostic bone marrow submitted for APEC14B1 diagnostic testing and who do not have a peripheral blood sample submitted containing > 1,000/uL circulating leukemia cells Patient must not have acute undifferentiated leukemia (AUL) Non-DS B-ALL patients with central nervous system [CNS]3 leukemia (CNS status must be known prior to enrollment) Note: DS patients with CNS3 disease are eligible but will be assigned to the DS-High B-ALL arm. CNS status must be determined based on a sample obtained prior to administration of any systemic or intrathecal chemotherapy, except for steroid pretreatment
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0
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 1.0-99.0, Malaria FOR 1,2,3: All of the following must be fulfilled for a volunteer to participate in this trial: 1. Meets age requirements for Arm currently being enrolled. 2. Available for the duration of the trial. 3. Family compound known resident or long-term resident (more than 1 year) of Doneguebougou, Mali or surrounding villages. 4. Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process. 5. In good general health and without clinically significant medical history in the opinion of the investigator. 6. Females of childbearing potential must be willing to use reliable contraception from 21 days prior to Study Day 0 and until 1 month after the last vaccination A reliable method of birth control includes one of the following: 1. Confirmed pharmacologic contraceptives (parenteral) delivery; 2. Intrauterine or implantable device to required pregnancy prevention includes the following: 1. Postmenopausal state: defined as no menses for 12 months without an alternative medical cause 2. Surgical sterilization 3. Unmarried AND not sexually active AND menstruating OR not menstruating females 12-17 years of age 4. NOTE: if a female of childbearing potential s status changes during the course of vaccination through 1 month post vaccination (e.g. they become >=18 years of age, married, or sexually active), the female will be required to start reliable contraception 7. Willing to have blood samples stored for future research. FOR GROUP 4: All of the following must be fulfilled for a volunteer to participate in this trial: 1. Meets age requirements for Arm currently being enrolled. 2. Available for the duration of the trial. 3. Family compound known resident or long-term resident (more than 1 year) of Doneguebougou, Mali or surrounding villages. 4. Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process. 5. In good general health and without clinically significant medical history in the opinion of the investigator. 6. Willing to have blood samples stored for future research. for Groups 1, 2, 3, (Year 2) All of the following must be fulfilled for a volunteer to continue to participate in this trial: 1. Previously enrolled in the study and has received at least 1 vaccination. 2. Available for the duration of the trial. 3. In good general health and without clinically significant medical history in the opinion of the investigator. 4. Females of childbearing potential must be willing to use reliable contraception from 21 days prior to scheduled vaccine dose #4 and until 1 month after the 4th vaccination. -A reliable method of birth control includes one of the following: 1. Confirmed pharmacologic contraceptives (parenteral) delivery; 2. Intrauterine or implantable device to required pregnancy prevention includes the following: 1. Postmenopausal state: defined as no menses for 12 months without an alternative medical cause 2. Surgical sterilization 3. Unmarried AND not sexually active AND menstruatingOR not menstruating females 12-17 years of age 4. NOTE: if a female of childbearing potential s status changes during the course of vaccination through 1 month post vaccination (e.g. they become greater than or equal to 18 years of age, married, or sexually active), the female will be required to start reliable contraception 5. Willing to have blood samples stored for future research. for Group 4 (Year 2): All of the following must be fulfilled for a volunteer to continue to participate in this trial: 1. Previously enrolled in the study 2. Available for the duration of the trial. 3. In good general health and without clinically significant medical history in the opinion of the investigator. 4. Willing to have blood samples stored for future research FOR 1, 2, 3: An individual will be excluded from participating in this trial if any one of the following is fulfilled: 1. Pregnant, as determined by a positive urine or serum beta human choriogonadotropin (beta-hCG) test (if female). NOTE: Pregnancy is also a criterion for discontinuation of any further vaccine dosing 2. Menstruating females 11 years of age and younger. (In order to avoid cultural implications of further assessing pregnancy potential i.e. sexual activity in this age group.) 3. Behavioral, cognitive, or psychiatric disease that in the opinion of the investigator affects the ability of the subject to understand and comply with the study protocol at a level appropriate for the subject s age. 4. Hemoglobin, white blood cell (WBC), absolute neutrophil count, or platelet levels outside the local laboratory defined limits of normal. (Subjects may be included at the investigator s discretion for not clinically significant values outside of normal range and <= Grade 2.) 5. Alanine transaminase (ALT) or creatinine (Cr) level above the local laboratory defined upper limit of normal. (Subjects may be included at the investigator s discretion for not clinically significant values outside of normal range and <= Grade 2.) 6. Infected with HIV 7. Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, endocrine, rheumatologic, autoimmune, hematological, oncologic, or renal disease by history, physical examination, and/or laboratory studies including urinalysis. 8. Clinically significant prolonged QTc (>450 milliseconds) on screening EKG 9. History of receiving any investigational product within the past 30 days. 10. Current or planned participation in an investigational vaccine study until the last required protocol visit. 11. Medical, occupational, or family problems as a result of alcohol or illicit drug use during the past 12 months. 12. History of a severe allergic reaction or anaphylaxis. 13. Known Severe asthma, defined as asthma that is unstable or required emergent care, urgent care, hospitalization, or intubation during the past 2 years, or that has required the use of oral or parenteral corticosteroids at any time during the past 2 years Autoimmune or antibody-mediated disease including but not limited to: systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sj(SqrRoot)(Delta)gren s syndrome, or autoimmune thrombocytopenia Immunodeficiency syndrome Seizure disorder (exception: history of simple febrile seizures) Asplenia or functional asplenia Use of chronic (>=14 days) oral or intravenous (IV) corticosteroids (excluding topical or nasal) at immunosuppressive doses (i.e., prednisone >10 mg/day) or immunosuppressive drugs within 30 days of Study Day 0 Allergy to latex or neomycin Adverse reaction to hepatitis A and/or typhoid and/or meningococcal vaccine in the past Adverse reaction to artemether/lumefantrine in the past 14. Receipt of: -Live vaccine within the past 4 weeks or a killed vaccine within the past 2 weeks to enrollment
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0
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 0.0-17.0, Respiratory Tract Infections Any respiratory symptom defined as tachypnea, shortness of breath, apnea, wheezing, cough, rhinitis, croup, sneezing, ear ache, or sore throat AND/OR Fever > 38.0 C Need of resuscitation at emergency room Need of immediate transfer to pediatric intensive care unit
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0
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 21.0-999.0, Chronic Obstructive Pulmonary Disease Age 21 years and above 2. Known diagnosis of COPD based on history AND spirometry demonstrating post bronchodilator FEV1/FVC ratio <0.7 3. Currently admitted inpatient for an acute COPD exacerbation as the primary diagnosis 4. Fit to participate in exercise therapy as determined by both physician and physiotherapist 5. Has the mental capacity to follow instructions 6. Experience shortness of breath on exertion 7. Have decreased ability to carry out activities due to shortness of breath 8. Willing to participate in the exercise program Uncontrolled/ unstable medical conditions such as severe chronic heart failure that make exercise unsafe 2. Pulmonary disorder other than COPD 3. Physical conditions that preclude the ability to participate in exercise or may impair exercise performance
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0
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 6.0-12.0, Asthma Asthma in Children Children 6-12 years of age; AND 2. Treated for an asthma exacerbation as determined clinically by the principal ED provider based on symptoms such as shortness-of-breath, cough, and wheezing; AND 3. Symptoms must improve following more than 1 dose of albuterol and more than 1 dose of systemic corticosteroids such that he/she can be safely discharged home; AND 4. Must have physician-diagnosed Attends a non-participating school; OR 2. Attends a participating school less than 5x/week; OR 3. Enrolled in another research study; OR 4. Patients who are hospitalized; OR 5. The patient or their consenting parent/guardian does not speak English or Spanish; OR 6. ICU admissions for asthma in the past year; OR 7. History of more than 2 hospitalizations for asthma in past year; OR 8. History of more than 2 controller medications for asthma in the past 30 days; OR 9. Study medication represents a step-down in asthma therapy in the judgement of the ED physician; OR 10. Parent does not have a cell phone; OR 11. Parent cannot send and receive text messages
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1
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 1.0-24.0, B Acute Lymphoblastic Leukemia B Lymphoblastic Lymphoma Central Nervous System Leukemia Mixed Phenotype Acute Leukemia Testicular Leukemia B-ALL and MPAL patients must be enrolled on APEC14B1 and consented to studies (Part A) prior to treatment and enrollment on AALL1732. Note that central confirmation of MPAL diagnosis must occur within 7 business days after enrollment for MPAL patients. If not performed within this time frame, patients will be taken off protocol APEC14B1 is not a requirement for B-LLy patients but for institutional compliance every patient should be offered participation in APEC14B1. B-LLy patients may directly enroll on AALL1732 White blood cell count (WBC) for patients with B-ALL (within 7 days prior to the start of protocol-directed systemic therapy) Age 1-9.99 years: WBC >= 50,000/uL Age 10-24.99 years: Any WBC Age 1-9.99 years: WBC < 50,000/uL with Testicular leukemia CNS leukemia (CNS3) Steroid pretreatment White blood cell count (WBC) for patients with MPAL (within 7 days prior to the start of protocol-directed systemic therapy) Patients with Down syndrome are not eligible (patients with Down syndrome and B-ALL are eligible for AALL1731, regardless of NCI risk group) With the exception of steroid pretreatment or the administration of intrathecal cytarabine, patients must not have received any prior cytotoxic chemotherapy for the current diagnosis of B-ALL, MPAL, or B-LLy or for any cancer diagnosed prior to initiation of protocol therapy on AALL1732 Patients who have received > 72 hours of hydroxyurea within one week prior to start of systemic protocol therapy Patients with B-ALL or MPAL who do not have sufficient diagnostic bone marrow submitted for APEC14B1 testing and who do not have a peripheral blood sample submitted containing > 1,000/uL circulating leukemia cells Patients with acute undifferentiated leukemia (AUL) are not eligible For Murphy stage III/IV B-LLy patients, or stage I/II patients with steroid pretreatment, the following additional apply T-lymphoblastic lymphoma Morphologically unclassifiable lymphoma Absence of both B-cell and T-cell phenotype markers in a case submitted as lymphoblastic lymphoma
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 18.0-999.0, Heart Failure Inpatient admission for acute decompensated heart failure Left ventricular systolic or diastolic heart failure Owns a smartphone with a data plan Hospice or life expectancy less than 6 months Palliative inotrope use Heart transplant listed, or status post transplant Ventricular assist devise present, or awaiting placement Not being discharged to home Unable to provide consent or comply with the intervention Current enrollment in a remote monitoring/ telehealth program
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0
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 0.0-999.0, Congenital Dyserythropoietic Anemia Patient with confirmed CDA No opposition to the use of health data for research purposes Patient opposed to participate in the study
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0
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 18.0-99.0, Asthma All patients referred to the Adult or Transitional Regional Asthma Clinics at participating hospitals On high-dose therapies, with or without the addition of continuous or frequent use of oral steroids (or steroid sparing therapies), as defined by the BTS (British Thoracic Society) Adult Asthma Management Guidelines (2016) Asthma patients who are not referred to the Adult or Transitional Regional Asthma Clinics at participating hospitals Any patients who are not on high-dose therapies, with or without the addition of continuous or frequent use of oral steroids (or steroid sparing therapies), as per the BTS (British Thoracic Society) Adult Asthma Management Guidelines (2016)
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1
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 18.0-75.0, Asthma Cough (Severe Asthmatics): 1. Ability and willingness to comply with the study procedures 2. Age ≥18 to ≤75 years at the time of informed consent 3. Severe asthma (as defined by GINA step 4/5 classification of asthma severity) after a detailed systematic assessment 4. History of asthma treatment with high doses of Inhaled Corticosteroids (≥1000 µg beclomethasone dipropionate daily, or equivalent) and an additional controller 5. Three patient groups with severe asthma will be investigated in the study and will be defined as follows: T2-High Severe Asthmatics (Group A) Persistent blood eosinophil count ≥0.3x10^9/mL and Persistent high FeNO levels ≥30 ppb and Adherence to inhaled and oral corticosteroid therapy T2-Low Severe Asthmatics (Group B) Persistent blood eosinophil count ≤0.2x10^9/Ml and Persistent low FeNO levels (<30ppb) T2 Intermediate Severe Asthmatics (Group D) Persistent blood eosinophil count ≥ 0.3x10^9/mL OR Persistent FeNO levels ≥ 30 ppb As stated above, these measurements are made at each clinic visit as part of routine care and will be available on all subjects prior to 6. A chest x-ray or CT scan obtained within 12 months before the time of informed consent and showing no new pathology requiring investigation as a potential cause for their cough Mild/moderate severe asthmatics (who have received a diagnosis of asthma from a physician and are defined as step 2/3 using the BTS/SIGN classification of severity and ACQ<1.5) aged 18-75 years inclusive will be recruited from general respiratory clinics in the Belfast HSC Trust. Patients must have the ability and willingness to comply with study procedures Baseline FEV1 ≤50% of predicted or ≤ 1.0L 2. Asthma exacerbation within 28 days before the time of informed consent or during screening 3. Major episode of infection requiring any of the following Admission to hospital for ≥24 hours within the 28 days before the time of informed consent Treatment with intravenous antibiotics within the 28 days before the time of informed consent or during Screening Treatment with oral antibiotics within the 14 days before the time of informed consent or during Screening 4. For adults: Active tuberculosis (TB) requiring treatment within the 12 months before the time of informed consent (patients are also required to have no recurrence of symptoms in the 12 months following completion of TB treatment), or 5. Known history of severe clinically significant immunodeficiency, including, but not limited to, human immunodeficiency virus infection and/or currently receiving or have historically received intravenous Ig for treatment for immunodeficiency Note: Immunodeficiency encompasses a wide spectrum of human conditions and/or diseases. A relative IgG deficiency that is thought, but not proven, to be a feature of severe asthma would not be exclusionary for the study. 6. Diagnosis or history of malignancy, or current investigation for possible malignancy 7. Other clinically significant medical disease that is uncontrolled despite treatment or that is likely, in the opinion of the investigator, to require a change in therapy or affect the ability to participate in the study 8. History of alcohol, drug, or chemical abuse that would impair or risk the patient's full participation in the study, in the opinion of the investigator 9. Current smoker or former smoker with a smoking history of >15 pack-years A current smoker is defined as someone who has smoked one or more cigarettes per day (or marijuana or pipe or cigar) for ≥30 days within the 24 months before the time of informed consent and for whom cotinine testing is positive. A former smoker is defined as someone who has smoked one or more cigarettes per day (or marijuana or pipe or cigar) for ≥30 days in his or her lifetime (as long as the 30-day total did not the 24 months before the time of informed consent) and for whom cotinine testing is negative. A pack-year is defined as the average number of packs per day times the number of years of smoking. 10. Initiation of or change in allergen immunotherapy within three months before the time of informed consent 11. Treatment with an investigational agent within 30 days of informed consent or 5 half-lives of the investigational agent, whichever is longer 12. Female patients who are pregnant or lactating
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 18.0-25.0, Hamstring Tightness Tight hamstring (Inability to achieve greater than 160° of knee extension with hip at 90° of flexion) Having hamstring injury in past 6 months Having any neurological or orthopedic disorder effecting low back and lower limbs
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0
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 18.0-65.0, Asthma Activity Role Qualification Fear of Movement Be diagnosed with bronchial asthma by a chest physician Being between the ages of 18-65 Being in a stable period Work in the last 12 months Severe chronic disease other than bronchial asthma (cancer, chronic obstructive pulmonary disease, chronic heart failure, neurological disease, etc.) Any physical disability that prevents walking Unable to comply with tests lack of reading, speaking and writing in Turkish
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1
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 18.0-100.0, Cough complaining chronic cough (lasting more than 8 weeks) Unwilling to participate
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0
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 18.0-999.0, Dyspnea Participants should be 18 years or older Presented at the ED with shortness of breath (asking the patient upon arrival in the triage what their primary complaint is for a referral to an emergency department) Written informed consent obtained from the patient Patients with dyspnea primary admitted because of a trauma
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 18.0-999.0, Asthma Have a physician diagnosis of asthma Require treatment with moderate to high-dose >2500mcg/day of fluticasone or equivalent, or use of oral steroids Also two of the following Requirement for additional daily treatment with other controller medication Daily Asthma symptoms Forced Expiratory Volume / Forced Vital Capacity (FEV1/FVC) < 70% and FEV1< 80% predicted ≥1 urgent care visits/year ≥3 oral steroid bursts/year Near-fatal asthma event Exhaled Nitric oxide (FeNO)<30 ppb Peripheral blood eosinophil count < 300 (x10-6/ul) Less than 18 years of age baseline FEV1 <30% predicted pregnant or nursing women current smokers or subject with >20 pack year history any history of intolerance of, or reaction to, Roflumilast Prisoners Patients with liver disease Subjects with Hepatic impairment (contraindicated in moderate-to-severe liver impairment: Child-Pugh Score Class B/C) for example Patients with clinically significant psychiatric history (i.e., suicidality, etc.) and psychiatric illness Patients using strong CYP 450 enzyme inducers (e.g., rifampicin, phenobarbital, carbamazepine, phenytoin)
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2
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 18.0-45.0, Asthma, Allergic Ages 18-45, both sexes included Mild intermittent asthma, defined as daytime asthma symptoms no more than 2 times per week, night time asthma symptoms no more than 2 times per month, FEV1 >80% of predicted, and asthma exacerbation requiring oral steroids 1 time or less per year Good general health as evidenced by medical history Vital signs will be within normal limits on admission to the study: oxygen saturation by pulse oximetry (SpO2) > 94%, systolic blood pressure between 150-90 mm Hg, diastolic blood pressure between 100-60 mm Hg, afebrile FEV1 of at least 80% of predicted at baseline Able to provide informed consent Any chronic medical condition considered by the PI as a contraindication to the exposure study including significant cardiovascular disease, diabetes, chronic renal disease, chronic thyroid disease, history of chronic infections/immunodeficiency, history of tuberculosis Physician directed emergency treatment for an asthma exacerbation within the preceding 12 months Orthopedic injuries or impediments that would preclude bicycle or treadmill exercise Viral upper respiratory tract infection within 4 weeks of challenge Any acute infection requiring antibiotics within 4 weeks of exposure or fever of unknown origin within 2 weeks of challenge Individuals who use daily controller medication for asthma. Pre-treatment with a short acting bronchodilator prior to exercise is allowed Nasal surgery within 6 months Mental illness or history of drug or alcohol abuse that, in the opinion of the investigator, would interfere with the participant's ability to comply with study requirements Any recent or current use of nicotine History of intubation for asthma
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1
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 18.0-60.0, Bioequivalence Healthy volunteers of both genders, aged ≥18 and ≤60 years Subjects with Body Mass Index (ΒΜΙ) ≥18.5 and <30.0 kg/m2 Healthy volunteers are declared healthy based on medical history, physical examination, ECG, pulmonary function test (a forced expiratory volume in 1 second (FEV1) ≥80% of the predicted normal value), and clinical laboratory values within the laboratory stated normal range; if not within this range, they must be without any clinical significance according to the Investigator Females who participate in the study are either at reproductive age i.e.pre-menopausal or unable to gestate [i.e. post-menopausal (absence of menses for 12 months prior to drug administration), hysterectomy, bilateral oophorectomy, tubal ligation at least 6 months prior to drug administration] Subjects that are non-smokers Subjects that, in the opinion of the principal investigator/medical officer, are able to communicate and comply with the study procedures and protocol restrictions as evidenced by the Informed Consent Form (ICF) duly read, signed and dated by the subject prior to study initiation Subjects able to use the inhalers according to given instructions, as judged by the Investigator or study nurse Hypersensitivity to the active substance(s) or to the excipient (lactose which contains small amounts of milk protein may cause allergic reactions) or related class (any sympathomimetic drug or any inhaled, intranasal, or systemic corticosteroid therapy) of the medicinal product Clinically significant illness or surgery within four weeks prior to dosing Clinically significant ECG abnormalities or vital sign abnormalities (seated systolic blood pressure <90 or >140 mmHg, seated diastolic blood pressure <50 or >90 mmHg or heart rate less than 50 or over 100 bpm) at screening Clinically significant history or presence of chronic bronchitis, emphysema,asthma or any other lung disease History or presence of pulmonary tuberculosis Viral or bacterial, upper or lower respiratory tract infection or sinus or middle ear infection within 4 weeks prior to the screening visit History or presence of significant cardiovascular, endocrinal, neurologic, immunological, psychiatric or metabolic disease History of significant alcohol or drug abuse within one year prior to the screening visit Regular use of alcohol within six months prior to screening visit (more than 14 alcohol units per week) [1Unit =150 ml of wine, 360 ml of beer, or 45 ml of 40% alcohol]. Inability to abstain from alcohol for the duration of study period Presence of disease markers for Hepatitis B, Hepatitis C or HIV at screening
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0
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 19.0-999.0, Asthma Korean asthma patients age ≥ 19 years old 2. Patients who have moderate to severe persistent asthma, as defined by GINA 2018 guideline, with ICS/LABA DPI use history 3. Patients who have uncontrolled asthma in FEV1 up to 60% and Asthma control test score < 20 4. Female subjects of child bearing potential must have a negative urine pregnancy test prior to first dose of study medication and that they must be agree to use adequate contraception during the study period 5. Patients who are able to use the inhaler 6. Patients who is willing to voluntarily sign the study consent form Patients who have diagnosed as clinically significant pulmonary diseases 2. Patients who have experienced life-threatening asthma within 12 months prior to screening or respiratory infection within 4 weeks prior to screening, or patients who have experienced any emergency visit or hospitalization due to acute asthma symptoms within 4 weeks prior to screening 3. Current and past smoker: Smoker defined as below Current smoker: smoking history within 90 days prior to screening Past smoker: smoking amount >10 pack year 4. Patients who currently are pregnant or lactating 5. Patients who are participating or going to participate in any interventional clinical trials 6. QT interval prolongation in ECG result at screening (420msec > male, 440msec > female) 7. Patients with hypersensitive to investigational products or to any component of the drug 8. Patients requiring treatment with any of the prohibited concomitant medications Use of the following medications is prohibited during the study due to drug-to-drug interaction with the study drug 9. Patients who took within 3 month prior to enrollment 10. Patients who did not show previous DPI drug compliance between 70% ~130%
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1
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 18.0-999.0, Asthma Chinese subjects aged between 18 and 90 years, and Have a diagnosis of asthma according to The Global Initiative for Asthma (GINA) guideline 2019. Asthma is defined as those with a consistent history and prior documented evidence of variable airflow obstruction, with evidence of an increase in FEV1 greater than 12% or 200 mL following bronchodilator or bronchial hyperresponsiveness on bronchial provocation testing, when stable Patients with respiratory diseases with other known respiratory diseases including chronic obstructive pulmonary disease, bronchiectasis, tuberculosis (TB)-destroyed lung parenchyma, history of lung resection and lung cancer Individuals older than 40 years with a smoking history of more than 10 pack-years Patients currently randomized in other clinical studies Pregnant women
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2
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 18.0-999.0, Cirrhosis, Liver Adults (great than 18 years of age) with a clinical diagnosis of cirrhosis (confirmed by compatible radiology, histology or fibroscan) Admitted to a study hospital site o Adult patients who do not have cirrhosis
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0
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 6.0-17.0, Asthma in Children History of provider-diagnosed asthma Meets one of the following definition for NAEPP guidelines uncontrolled moderate persistent asthma or severe persistent asthma in the past 12 months NAEPP step 3-4 with one of the following in the past 12 months Two Asthma Control Test (ACT) scores <20 Urgent Care or Emergency Department visit or hospitalization for asthma >2 prednisone bursts NAEPP step 5-6 Current health insurance coverage at enrollment. This will be verified at V1 at the registration desk. If the family loses insurance during the study, the patient will be referred to the pulmonary social worker and financial office for assistance Reside at a primary home on average 5 out of 7 days a week Primary home is within a 40 mile radius of Cincinnati Children's Base location or PI's discretion Received biologic therapy 6 months prior to enrollment Received systemic steroids 6 weeks prior to enrollment Active chronic disease apart from asthma or allergic disease Co-morbid lung disease Dependence on immunosuppressive drugs for a condition other than asthma Participant is pregnant Has a severe bleeding disorder Has significant developmental disability Share a bedroom with a currently enrolled Breath Warriors study participant
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2
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 18.0-65.0, Asthma Being 18-65 years old T Turkish reading, writing, understanding Volunteering to participate in the research Having communication problems, not being cooperative, having a psychiatric diagnosis or using medication Severe comorbid diseases (heart, respiratory, gastrointestinal, neurological diseases) that may cause movement limitation
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2
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 18.0-999.0, Hematopoietic and Lymphoid Cell Neoplasm Malignant Solid Neoplasm Diagnosis of cancer with evidence of active disease Dyspnea on exertion with an average intensity level >= 4/10 on a modified Borg scale Outpatient at participating centers Ambulatory and able to walk, with or without walking aid On strong opioids with morphine equivalent daily dose (MEDD) of 60-370 mg for >= 1 week (wk), with stable (i.e. +/ ) regular dose over the last 3 days (d) Karnofsky performance status >= 40% Able to complete study assessments Able to speak English or Spanish Reside within 50 miles of participating centers Dyspnea at rest >= 7/10 on modified Borg scale at enrollment Supplemental oxygen requirement > 6 L/min Delirium (i.e. Memorial Delirium Assessment Scale >= 13) History of unstable angina or myocardial infarction 1 month prior to enrollment Resting heart rate > 120 beats/min at enrollment Systolic pressure > 180 mmHg or diastolic pressure > 100 mmHg at enrollment History of substance use disorder or abnormal urinary drug screen within the past year, or at risk of opioid abuse as determined by Screener and Opioid Assessment for Patients with Pain (SOAPP14) >= 7 History of or known allergy to fentanyl or morphine sulfate Currently prescribed benzodiazepines Severe anemia (Hemoglobin [Hb] < 7 g/L) if documented in the last month and not corrected prior to study enrollment
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0
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 18.0-999.0, Asthma Cough Variant Asthma Informed consent for participating in the study Age ≥18 years Cough variant asthma or cough predominant asthma diagnosed and treated with inhaled corticosteroids (ICS) regularly at least 8 weeks prior to enrollment Lack of informed consent Age <18 years Diagnosis of cough variant or cough predominant asthma shorter than 8 weeks before enrollment Symptoms of infection or asthma exacerbation 4 weeks prior to beginning of the study or during the study Comorbidity that could prevent patient from using DPI or MDI (i e. advanced vision disorders, some mental diseases, advanced neurological diseases)
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1
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 0.0-999.0, Asthma in Children Allergy Planning to deliver at the study hospital. 2. History of or concurrent asthma or allergic rhinitis (hay fever) in either biologic parent or sibling (at least one shared biological parent) by parental report. The presence of paternal or sibling allergy or asthma will be ascertained by maternal report. 3. Maternal age > 18 years at the time of study enrollment Maternal HIV infection at time of delivery. 2. Plans for the family to move out of the geographic area during the period of the study. 3. Does not speak English. 4. Maternal use of progesterone during pregnancy to prevent preterm birth. 5. Past or current medical problems or findings from physical examination or laboratory testing which, in the opinion of the investigator or designee, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study
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0
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 18.0-70.0, Helminthiasis Helminth Infection The included volunteer is a researcher within parasitology with focus on Trichuris trichiura and Trichiura suis. He planned to infect himself under medical supervision. This was his third self-infection with Trichuris. The only clinical criterion for his in the study was that he was healthy N/A
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0
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 18.0-75.0, Irritable Bowel Syndrome Patients who fulfil Rome IV for the diagnosis of IBS. 2. Patients were investigated to other gastrointestinal organic cause(s). 3. Moderate-to-severe IBS symptoms, as indicated by a score of ≥175 on the IBS Severity Scoring System (IBS-SSS) Pregnant or lactating women. 2. The use of antibiotics or probiotics within 1 month prior to FMT. 3. Immunocompromised patients defined as those treated by immune suppressive medications. 4. Patients with co-morbidity such as kidney failure or chronic heart disease. 5. System disease such as diabetes. 6. Patients with serious psychiatric disorders or drug abuse
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0
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 18.0-45.0, Asthma Allergic Asthma for all subjects Age between 18 and 45 years old Smoking history ≤2 packyears. Specific for the two groups Group 1. Patients with ongoing asthma Age of onset of asthmatic symptoms: 0 years Documented history of asthma diagnosed according to latest GINA guidelines, i.e. respiratory symptoms and either bronchodilator reversibility (improvement in FEV1 of more than 12% of baseline (and at least 200 mL) after inhalation of 800 µg salbutamol) Use of inhaled corticosteroids or either persistent symptoms of wheeze, cough, or dyspnea or regular use of β2 agonists at least once a week during the last 2 months PC20 methacholine < 8 mg/ml Group 2. Non-asthmatic controls FEV1 <1.2 L Subjects must be able to adhere to the study visit schedule and other protocol requirements A subject is not eligible to enter and participate if he has not signed and dated a written informed consent form prior to participation in the study A subjects is not eligible to enter and participate if he does not agree that we inform his general practitioner Upper respiratory tract infection (e.g. colds), within 6 weeks Serious acute infections (such as hepatitis, pneumonia or pyelonephritis) in the previous 3 months Signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematologic, endocrine, pulmonary, cardiac, neurologic or cerebral disease Malignancy within the past 5 years (except for squamous or basal cell carcinoma of the skin that has been treated with no evidence of recurrence) Known recent substance abuse (drug or alcohol) Females of childbearing potential without an efficient contraception unless they meet the following definition of post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum FSH >40 mIU/mL or the use of one or more of the following acceptable methods of contraception: 1. Surgical sterilization (e.g. bilateral tubal ligation, hysterectomy). 2. Hormonal contraception (implantable, patch, oral, injectable). 3. Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/cream/suppository. 4. Continuous abstinence
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 0.0-22.0, Acute Myeloid Leukemia All patients must be enrolled on APEC14B1 and consented to Screening (Part A) prior to enrollment and treatment on AAML1831. Submission of diagnostic specimens must be done according to the Manual of Procedures). Risk stratification will not be possible without the submission of viable samples. Given there are multiple required samples, bone marrow acquisition techniques such as frequent repositioning or performing bilateral bone marrow testing should be considered to avoid insufficient material for required studies. Consider a repeat marrow prior to starting treatment if there is insufficient diagnostic material for the required studies Patients must be less than 22 years of age at the time of study enrollment Patient must be newly diagnosed with de novo AML according to the 2016 World Health Organization (WHO) classification with or without extramedullary disease Patient must have 1 of the following >= 20% bone marrow blasts (obtained within 14 days prior to enrollment) In cases where extensive fibrosis may result in a dry tap, blast count can be obtained from touch imprints or estimated from an adequate bone marrow core biopsy < 20% bone marrow blasts with one or more of the genetic abnormalities (sample obtained within 14 days prior to enrollment) A complete blood count (CBC) documenting the presence of at least 1,000/uL (i.e., a white blood cell [WBC] count >= 10,000/uL with >= 10% blasts or a WBC count of >= 5,000/uL with >= 20% blasts) circulating leukemic cells (blasts) if a bone marrow aspirate or biopsy cannot be performed (performed within 7 days prior to enrollment) ARM C: Patient must be >= 2 years of age at the time of Late Callback ARM C: Patient must have FLT3/ITD allelic ratio > 0.1 as reported by Molecular Oncology Patients with myeloid neoplasms with germline predisposition are not eligible Fanconi anemia Shwachman Diamond syndrome Patients with constitutional trisomy 21 or with constitutional mosaicism of trisomy 21 Any other known bone marrow failure syndrome Any concurrent malignancy Juvenile myelomonocytic leukemia (JMML) Philadelphia chromosome positive AML Mixed phenotype acute leukemia Acute promyelocytic leukemia
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 18.0-40.0, Asthma Patients categorized as mild to moderate persistent asthma category according to the "National Asthma Education and Prevention Program" Use of oral steroids within the four-week run-in period Change in inhaled steroid dose and type Other significant unstable medical conditions They have undertaken Buteyko breathing technique previously
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1
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 14.0-80.0, Asthma Chest Syndrome Clinical Anxiety Clinical Depression Lung Function Quality of Life Eosinophilia Nitric Oxide Airway Responsiveness Induced Sputum all subjects agreed to participate, understand the project, observe the use of drugs, agree to follow-up, and signed informed consent; 2. the age of more than 14 and less 80 years old, gender and ethnicity are not limited; 3. the duration time was more than 6 months,and chest tightness was the only complaint, without breathing, short of breath, chronic cough; 4. no wheezing; 5. a diagnosis of asthma supported by one or more other characteristics bronchial provocation test positive improvement in forced expiratory volume at one second (FEV1) of more than 12% and 200 mL after inhaled salbutamol variability in diurnal peak expiratory flow (PEF) of more than 10% for one day during one week. 6. bronchodilator and glucocorticoid treatment is effective; 7. the following diseases by the corresponding doctors: coronary heart disease, myocarditis, heart failure, gastroesophageal reflux disease(GERD), neuromuscular disease, and mental disease can not cooperate with related inspection or for other reasons; 2. patients with chronic obstructive pulmonary disease, interstitial pneumonia, active tuberculosis, community acquired pneumonia, lung cancer, bronchiectasis, cor pulmonale, pulmonary embolism, and accompanied with serious systematic disease (such as coronary heart disease, myocarditis, heart failure, gastroesophageal reflux disease, neuromuscular disease, etc); 3. history of drug abuse, alcohol abuse or anesthesia or with a history of mental illness (schizophrenia, obsessive-compulsive disorder, depression) and against personality, motivation, suspicious, or other emotional or mental issues that may affect participation in the study; 4. taking part in other drug clinical trial project, or drop out less than 3 months; 5. during pregnancy, lactation women; 6. obvious abnormal of High Resolution CT
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1
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 6.0-16.0, Asthma in Children male or female gender age between 6 and 16 years first asthma diagnosis according to GINA recommendations (http://ginasthma.org), including assessment of the history of respiratory symptoms (wheezing, shortness of breath, chest tightness and cough) and environmental exposures (smoke, mold, vehicular traffic), spirometry (FEV1/FVC<0.90 at baseline, >12% FEV1 increase from baseline after bronchodilator inhalation) and skin prick tests exacerbations requiring oral corticosteroids in the last four weeks use of controller medications (leukotriene receptor antagonists and/or inhaled corticosteroids) in the last four weeks respiratory infections in the last four weeks immunological, metabolic, cardiac or neurological diseases major malformations of the respiratory system active smoking
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 18.0-999.0, Asthma Diagnosis of severe persistent asthma Systemic steroids treatment for at least 6 months and/or ≥2 exacerbations in the last year Need to initiate monoclonal antibody therapy according to guidelines Age ≥18 years Signed Informed consent Patients able to collaborate in the required procedures Diagnosis of cognitive impairment
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 18.0-999.0, Asthma Healthy subjects Written informed consent indicating that they understand the purpose and procedures required for the study and are willing to participate in the study Age higher than 18 years No prior history of any chronic respiratory disease including asthma No prior history of allergy, i.e. allergic rhinitis, allergic conjunctivitis, hay fever, eczema No clinically significant abnormalities as determined by medical history, measurement of vital signs, physical examination, hematologic assessments and ECG at visit 1 Normal lung function with FEV1 > 90%. Non-severe asthmatics subjects • Written informed consent indicating that they understand the purpose and procedures required for the study and are willing to participate in the study Age higher than 18 years Diagnosis of non-severe asthma according to the Global Initiative for Asthma (GINA), i.e. GINA steps 1, 2 or 3 (18) Active smoker or former smoker Diagnosis of chronic obstructive pulmonary disease (COPD), cystic fibrosis, or other significant respiratory disorder including significant occupational or environmental exposures with ongoing respiratory symptoms CT scan abnormality related to any respiratory disease other than asthma Recent asthma exacerbation (less than 6 weeks before bronchoscopy) Contraindications related to bronchoscopy coagulation disorders unstable cardiovascular conditions FEV1 lower than 1 litter a fasting state of less than 6 hours for food and less than 2 hours for drink Contraindications to general anesthesia or medications (for propofol: hypersensitivity to the active substance and to any of the excipients; for lidocaine: hypersensitivity to the active substance and to any of the excipients or to local anesthetics of the amide type, epilepsy, porphyria) used in the bronchoscopy procedure
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 18.0-999.0, COVID-19 SARS-CoV-2 Infection Adults who agree to participate and sign informed consent. 2. Suspected case, according to the operational definition (CONAVE).* 3. In the case of confirmed cases, will be those individuals who meet the operational definition of a suspected case and have a confirmed diagnosis by molecular biology, according to the operational definition (CONAVE).** 4. The time of acute respiratory symptoms should be no longer than 72h. 5. Negative to the rapid test for influenza A/B. 6. Live in an urban area with easy access for visits Person of any age that has presented at least two of the following signs and symptoms: cough, fever or headache Accompanied by at least one of the following signs or symptoms: Dyspnea (signal of severity) Arthralgia Myalgia Odynophagia / pharyngeal burning Rhinorrhea Conjunctivitis Chest pain **SARS-CoV2 infection confirmed by molecular diagnostic by one laboratory from the National Network of Public Health Laboratories recognized by InDRE Pregnancy. 2. Evidence of severe acute respiratory infection, even if it meets the for a suspected or confirmed case. 3. Hepatic insufficiency 4. Diseases that occur with immunosuppression or therapeutic immunosuppression. 5. Heart diseases; controlled hypertension is allowed. 6. Metabolic diseases; controlled diabetes mellitus is allowed. 7. Individuals who have been treated with DLE in the last 6 months. National Committee for Epidemiological Surveillance. InDRE: Institute of Epidemiological Diagnosis and Reference
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 18.0-999.0, COVID Corona Virus Infection Respiratory Failure Respiratory Distress Syndrome, Adult ARDS, Human SARS (Severe Acute Respiratory Syndrome) Patients (age 18 years and older) who have tested positive or suspected/presumed positive for CoViD-19 using PCR real time test 2. Patients with cough, shortness of breath or respiratory compromise (RR>24/min, increased work of breathing.) 3. O2 Saturation less than or equal to 96% on room air or sensation 4. Agrees to use the gammaCore Sapphire device as intended and to follow all of the requirements of the study including recording required study data 5. Permission for early am blood draw to freeze for subsequent lab tests and sequencing as related to CoViD-19 sequelae 6. Patient is able to provide signed and witnessed Informed Consent On home/therapy oxygen (i.e. for chronic obstructive pulmonary disease (COPD) patients) at baseline prior to development of CoViD-19 2. Already using gammaCore® (nVNS) for other medical conditions 3. A history of aneurysm, intracranial hemorrhage, brain tumors, or significant head trauma 4. Known or suspected severe atherosclerotic cardiovascular disease, severe carotid artery disease (e.g., bruits or history of transient ischemic attack or cerebrovascular accident), congestive heart failure, known severe coronary artery disease, myocardial infarction documented within past 90 days, or current or recent history of life-threatening arrhythmia (sustained ventricular tachycardia, ventricular fibrillation, second or third-degree heart block, uncontrolled atrial fibrillation or uncontrolled atrial flutter) 5. Patients with clinically significant hypertension, hypotension, bradycardia, or tachycardia (as per investigator discretion) 6. Current implantation of an electrical and/or neurostimulator device, including but not limited to a cardiac pacemaker or defibrillator, vagal neurostimulator, deep brain stimulator, spinal stimulator, bone growth stimulator, or cochlear implant 7. Current implantation of metal cervical spine hardware or a metallic implant near the gammaCore® stimulation site 8. Belongs to a vulnerable population or has any condition such that his or her ability to provide informed consent, comply with the follow-up requirements, or provide self-assessments is compromised (e.g. homeless, developmentally disabled and prisoner) 9. Compromised access to peripheral veins for blood sampling. 10. Pregnant women 11. Patients with active cancer or those who have had recent cancer treatment
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 16.0-999.0, Covid19 Convalescence Respiratory rate > 30 breaths/min; PLUS 2. Severe respiratory distress; or SpO2 ≤ 88% on room air or PaO2/FiO2≤ 300 mm of Hg, PLUS 3. Radiological evidence of bilateral lung infiltrate, AND OR 4. Systolic BP < 90 mm of Hg or diastolic BP <60 mm of Hg. AND OR 5. 1 to 4 AND or patient in Ventilator support Patients below18 years. 2. Pregnant women and breast-feeding mothers. 3. Previous history of allergic reaction to plasma 4. Those who will not give consent
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 18.0-999.0, Heart Failure; With Decompensation Heart Failure，Congestive Heart Failure Acute Patient admitted in Hospital at Home with signs and/or symptoms of new-onset or decompensated heart failure, according with the definition of 2016 European Society of Cardiology (ESC) guidelines on Heart Failure Written informed consent signed by both the patient and the main caregiver Main caregiver with low IT skills (e.g. unable to use a smartphone) Patient in whom body weight or accurate daily urine output cannot be measured Patient with history of neoplastic/degenerative disease and with estimated life expectancy less than 3 months Patient with decompensated liver cirrhosis (Child-Pugh score B o C)
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 18.0-999.0, Corona Virus Infection Pneumonia Acute Respiratory Failure The study was planned retrospectively, cross-sectionally and observationally with 193 patients hospitalized between 16 March 2020 and 15 May 2020 in five different coronavirus disease 2019 intensive care units in two campuses of our hospital Health workers, patients hospitalized less than 24 hours, patients with negative polymerase chain reaction tests, and patients who returned to intensive care unit after discharge were excluded from the study
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0
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 18.0-85.0, Asthma Asthma diagnosis according to GINA / ATS guidelines Age ≥18 years •cognitive impairment
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 12.0-70.0, Asthma adolescent is 12-15 years old caregiver is between 18-70 years-old adolescent lives in the residence of caregiver adolescent has a physician-verified persistent asthma diagnosis and an active inhaled corticosteroid prescription for ≥ 6 months adolescent poorly controlled asthma (score of ≤ 19 on the Asthma Control Test) Endorsing one or more symptoms of poorly controlled asthma according to national guidelines on more than four separate days in the past two weeks: 1. Use of any short-acting beta agonist (e.g., quick relief) medication to relieve asthma symptoms 2. Experiencing specific asthma symptoms (i.e., wheezing, tightness of chest, coughing) during the day or night 3. Nighttime awakening 1 or more times per week due to asthma symptoms 4. Activity limitation due to asthma 5. 2 or more exacerbations requiring oral systemic corticosteroids in the past year 6. 2 or more ED visits or one hospitalization in the past year 7. 2 or more urgent medical care visits due to asthma in the past year adolescent and caregiver speak and read English Family is currently involved in an asthma management intervention above and beyond usual care, or Adolescent has a significant developmental delay that would preclude participation
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 18.0-75.0, COVID-19 Conscious consent to participate in the study Patients 18 to 75 years of age with COVID-19 who have been diagnosed with PCR Strong clinical suspicion of covid 19 with positive findings in CT Scan Shortness of breath Patients with HIV Patients with cancer undergoing chemotherapy Patients receiving Immune Mediators Patients need hospitalization in the intensive care unit Patients with uncontrolled heart, kidney or liver failure Pregnant or lactating women Intolerance to the drugs used in this study (symptoms such as diarrhea, nausea, vomiting and respiratory problems)
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0
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 16.0-999.0, Respiratory Disease Male or Female, aged ≥16 years A confirmed, clinician made diagnosis of the following (supported by standard accepted diagnostic criteria) Asthma with a ≤10 pack year smoking history (confirmed by spirometry and/or airway inflammation and function tests) COPD (confirmed by spirometry) Bronchiectasis (confirmed by CT scan) Interstitial Lung Disease (confirmed by CT scan and MDT/specialist consensus) has or is eventually proven to have a histological OR radiological and MDT confirmed diagnosis of primary lung cancer, and not yet started treatment for this current pneumonia (confirmed by chest imaging) Breathing Pattern Disorder, with no other significant respiratory co-morbidity (specialist confirmed) Healthy controls (defined as no current clinical diagnosis of, or be receiving treatment for, a lung or other significant medical disorder) Existing co-morbidities that may prevent them from performing spirometry, for those with asthma, COPD, or healthy controls, with no spirometry in the previous 12 months (at the discretion of the clinical investigator) Unable to comprehend the study, provide informed consent, and unable to perform any of the study procedures Requirement of supplemental oxygen (pneumonia participants only)
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 18.0-999.0, Asthma All patients with hospitalization for asthmatic exacerbation according to physician's clinical judgement Age greater than 18 years old Inappropriate diagnosis of asthma exacerbation after evaluation
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1
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 18.0-999.0, Asthma Age > 18 years A doctor's diagnosis of asthma (mild in severity) No current regular asthma treatment or regular asthma treatment in the preceding 6 weeks; only a history of using short-acting bronchodilator inhalers on demand is allowed Pre-bronchodilator FEV1 value > 80% of the predicted value History or evidence of chronic respiratory disease other than asthma History or evidence of other disease, blood test results outside the normal reference range or medication use that would impair the ability of participants to safely undertake the study or the ability of researchers to interpret the study results; this includes, but is not limited to, the use of anticoagulants (e.g. warfarin), adenosine diphosphate (ADP) receptor inhibitors (e.g. clopidogrel), antiretroviral therapy (due to the potential for interaction with fluticasone), certain antifungal agents (due to the potential for interaction with fluticasone) and beta-blockers Current use or use in the last 6 weeks of systemic or nasal topical steroids, inhaled corticosteroids or systemic immunosuppressants Platelet count < 150 x 109/L or international normalised ratio (INR) > 1.5 History of smoking > 5 pack years, current smoker or history of smoking in the last 4 weeks Current vaping or history of vaping in the last 4 weeks Current illicit drug use/abuse Abnormal chest x-ray appearance Signs or symptoms of upper respiratory tract infection or lower respiratory tract infection in the preceding 6 weeks Cardiac conduction abnormalities on electrocardiogram (ECG)
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 18.0-65.0, Asthma Obesity Asthma Cohort Adequate completion of informed consent process with written documentation Male and female patients, 18 years old, inclusive Physician diagnosis of asthma for > 1 year Able to perform reproducible spirometry according to ATS Post-bronchodilator FEV1 ≥ 60% of predicted at Visit 0 All racial/ethnic backgrounds may participate BMI ≥ 30 kg/m2 Regular treatment with ICS or ICS/LABA and/or LAMA combination medication for at least 3 months; on a stable dose for the 4 weeks prior to Visit 0 Asthma Cohort Respiratory tract infection within the 4 weeks prior to Visit 0 Oral or systemic corticosteroid burst (for any indication) within the 4 weeks prior to Visit 0. One-time doses, such as intra-articular injections into a shoulder or knee joint, require a 4 week washout prior to Visit 0 Asthma-related ER visit within the previous 4 weeks of Visit 0 History of ICU admission/intubation due to asthma in the past 1 year Three or more asthma exacerbations requiring treatment with systemic corticosteroids in the past year consistent with severe asthma Asthma exacerbation requiring systemic corticosteroids within the 4 weeks prior to Visit 0 Significant concomitant medical illness, including (but not limited to) heart disease, cancer, uncontrolled diabetes, other chronic lung diseases Chronic renal failure (creatinine > 2.0) at Visit 0
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1
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 18.0-60.0, Bioequivalence Healthy volunteers of both genders, aged ≥18 and ≤60 years. 2. Subjects with Body Mass Index (ΒΜΙ) ≥18.5 and <30.0 kg/m2. 3. Healthy volunteers are declared healthy based on medical history, physical examination, ECG, pulmonary function test (a forced expiratory volume in 1 second (FEV1) ≥80% of the predicted normal value), and clinical laboratory values within the laboratory stated normal range; if not within this range, they must be without any clinical significance according to the Investigator. 4. Females who participate in the study are either at reproductive age i.e.pre-menopausal or unable to gestate [i.e. post-menopausal (absence of menses for 12 months prior to drug administration), hysterectomy, bilateral oophorectomy, tubal ligation at least 6 months prior to drug administration]. 5. Subjects that are non-smokers. 6. Subjects that, in the opinion of the principal investigator/medical officer, are able to communicate and comply with the study procedures and protocol restrictions as evidenced by the Informed Consent Form (ICF) duly read, signed and dated by the subject prior to study initiation. 7. Subjects able to use the inhalers according to given instructions, as judged by the Investigator or study nurse Hypersensitivity to the active substance(s) or to the excipient (lactose which contains small amounts of milk protein may cause allergic reactions) or related class (any sympathomimetic drug or any inhaled, intranasal, or systemic corticosteroid therapy) of the medicinal product 2. Clinically significant illness or surgery within four weeks prior to dosing. 3. Clinically significant ECG abnormalities or vital sign abnormalities (seated systolic blood pressure <90 or >140 mmHg, seated diastolic blood pressure <50 or >90 mmHg or heart rate less than 50 or over 100 bpm) at screening. 4. Clinically significant history or presence of chronic bronchitis, emphysema,asthma or any other lung disease. 5. History or presence of pulmonary tuberculosis. 6. Viral or bacterial, upper or lower respiratory tract infection or sinus or middle ear infection within 4 weeks prior to the screening visit. 7. History or presence of significant cardiovascular, endocrinal, neurologic, immunological, psychiatric or metabolic disease. 8. History of significant alcohol or drug abuse within one year prior to the screening visit. 9. Regular use of alcohol within six months prior to screening visit (more than 14 alcohol units per week) [1Unit =150 ml of wine, 360 ml of beer, or 45 ml of 40% alcohol]. 10. Inability to abstain from alcohol for the duration of study period. 11. Presence of disease markers for Hepatitis B, Hepatitis C or HIV at screening. 12. Positive results for drugs of abuse (barbiturates, marijuana, opioids, benzodiazepines and methadone) in saliva before each administration. 13. Positive alcohol breath test before each administration. 14. Use of soft drugs (such as marijuana) within three months prior to screening or hard drugs such as crack, cocaine or heroin within one year prior to screening visit 15. Intake of any drugs known to induce or inhibit hepatic drug metabolism (examples of inducers are barbiturates, carbamazepine, phenytoin, glucocorticoids, rifampin/rifabutin; examples of inhibitors are, erythromycin, ketoconazole, indinavir, cobicistat-containing products) within one month prior to administration of the study medication. Under these circumstances, subject will be judged by the principal investigator. 16. History of peptic ulcer, other gastrointestinal disorders (e.g. chronic diarrhoea, irritable bowel syndrome) or unresolved gastrointestinal symptoms (e.g. diarrhea, vomiting) or significant hepatic, renal or other condition that is known to interfere with the absorption, distribution, metabolism or excretion of the drug. 17. Use of oral or parenteral corticosteroids in the previous four 4 weeks 18. Eye disorders especially Glaucoma (or a family history of glaucoma) 19. Use of prescription medication (within 14 days prior to the first administration of study medication) or over-the-counter (OTC) products (including food supplements vitamins and herbal supplements) within one week (7 days) prior to the first administration of study medication, except for topical products without systematic absorption. Contraceptives are allowed. 20. Vaccination for prophylaxis from seasonal flu or any other vaccination within seven days prior to administration 21. History of allergy to any food, intolerance or special diet, that in the opinion of the medical sub-investigator could contraindicate the subject's participation in the study. 22. A depot injection or an implant of any drug (except hormonal contraceptives) within 3 months prior to treatment administration. 23. Donation of plasma (500 ml) within 7 days prior to treatment administration. 24. Donation of whole blood or loss of whole blood ≥ 500 ml prior to administration of the study medication within 30 days prior to treatment administration. 25. Participation in another clinical trial simultaneously. 26. Subjects receiving special diet or having intolerance in any of the provided study meals or refusing to eat the study meals 27. Application of tattoo or body piercing within 30 days prior to treatment administration. 28. Non-tolerance to venipuncture. 29. Breastfeeding women. 30. Positive pregnancy test at screening 31. Females of reproductive age that had sexual intercourse with a non-sterile male partner without protection within 14 days prior to drug administration Reliable contraception methods are considered the following combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal or transdermal progestogen-only hormonal contraception associated with inhibition of ovulation oral, implanable or injectable intrauterine device (IUD) intrauterine hormone-releasing system (IUS) bilateral tubal occlusion vasectomised partner sexual abstinence
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0
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 1.0-30.0, Down Syndrome Recurrent B Acute Lymphoblastic Leukemia Patients must be >= 1 and < 31 years at time of enrollment Patients must have first relapse of CD19+ B-ALL (relapse blasts must express CD19) in one of the following categories Isolated bone marrow relapse Isolated central nervous system (CNS) (excluding known optic nerve/retinal and CNS chloromas) and/or testicular relapse Combined bone marrow with extramedullary relapse in the CNS (excluding known optic nerve/retinal and CNS chloromas) and/or testes Patients with Down syndrome (DS) are eligible in the following categories Isolated bone marrow relapse Combined bone marrow with CNS (excluding known optic nerve/retinal and CNS chloromas) and/or testicular relapse Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2. Use Karnofsky for patients > 16 years of age and Lansky for patients =< 16 years of age Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study Patients with B-lymphoblastic lymphoma (B-LLy) Patients with Burkitt leukemia/lymphoma or mature B-cell leukemia Patients with Philadelphia chromosome positive (Ph+) B-ALL Patients with mixed phenotype acute leukemia (MPAL) Patients with known Charcot-Marie-Tooth disease Patients with known MYC translocation associated with mature (Burkitt) B-cell ALL, regardless of blast immunophenotype Patients with active, uncontrolled infection defined as Positive bacterial blood culture within 48 hours of study enrollment Receiving IV or PO antibiotics for an infection with continued signs or symptoms. Note: Patients may be receiving IV or oral antibiotics to complete a course of therapy for a prior documented infection as long as cultures have been negative for at least 48 hours and signs or symptoms of active infection have resolved. For patients with clostridium (C.) difficile diarrhea, at least 72 hours of antibacterial therapy must have elapsed and stools must have normalized to baseline Fever above 38.2 degrees Celsius (C) within 48 hours of study enrollment with clinical signs of infection. Fever without clinical signs of infection that is attributed to tumor burden is allowed as long as blood cultures are negative for > 48 hours
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0
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 16.0-999.0, Asthma Referral to a specialist severe asthma clinic in the UK due to inadequate asthma control None
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1
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 0.0-999.0, Liver Fibrosis Liver Steatosis Weight Loss IInclusion Age 13-18 years No other chronic disease except the metabolic syndrome Not taking any medication Children that are known to suffer from genetic/metabolic disorders that can cause steatosis Wilson disease, hypothyroidism, autoimmune hepatitis, Alpha 1 antitrypsin Children infected with HBV or HCV, HAV Children that use medications that can cause liver steatosis amiodarone, MTX, Corticosteroids Children with significant ethanol consumption ->10 gr per day for women and >20gr per day for men Pregnant women Obesity due to syndromes or monogenic disease General withdraw • If the participant withdraws his consent
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0
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 18.0-60.0, Bioequivalence Healthy volunteers of both genders, aged ≥18 and ≤60 years Subjects with Body Mass Index (ΒΜΙ) ≥18.5 and <30.0 kg/m2 Healthy volunteers are declared healthy based on medical history, physical examination, ECG, pulmonary function test (a forced expiratory volume in 1 second (FEV1) ≥80% of the predicted normal value), and clinical laboratory values within the laboratory stated normal range; if not within this range, they must be without any clinical significance according to the Investigator Females who participate in the study are either at reproductive age i.e.pre-menopausal or unable to gestate [i.e. post-menopausal (absence of menses for 12 months prior to drug administration), hysterectomy, bilateral oophorectomy, tubal ligation at least 6 months prior to drug administration] Subjects that are non-smokers Subjects that, in the opinion of the principal investigator/medical officer, are able to communicate and comply with the study procedures and protocol restrictions as evidenced by the Informed Consent Form (ICF) duly read, signed and dated by the subject prior to study initiation Subjects able to use the inhalers according to given instructions, as judged by the Investigator or study nurse Hypersensitivity to the active substance(s) or to the excipient (lactose which contains small amounts of milk protein may cause allergic reactions) or related class (any sympathomimetic drug or any inhaled, intranasal, or systemic corticosteroid therapy) of the medicinal product Clinically significant illness or surgery within four weeks prior to dosing Clinically significant ECG abnormalities or vital sign abnormalities (seated systolic blood pressure <90 or >140 mmHg, seated diastolic blood pressure <50 or >90 mmHg or heart rate less than 50 or over 100 bpm) at screening Clinically significant history or presence of chronic bronchitis, emphysema,asthma or any other lung disease History or presence of pulmonary tuberculosis Viral or bacterial, upper or lower respiratory tract infection or sinus or middle ear infection within 4 weeks prior to the screening visit History or presence of significant cardiovascular, endocrinal, neurologic, immunological, psychiatric or metabolic disease History of significant alcohol or drug abuse within one year prior to the screening visit Regular use of alcohol within six months prior to screening visit (more than 14 alcohol units per week) [1Unit =150 ml of wine, 360 ml of beer, or 45 ml of 40% alcohol] Inability to abstain from alcohol for the duration of study period
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0
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 18.0-75.0, Asthma; Eosinophilic Severe Asthma Patients between 18 and 75 years old Patients diagnosed with severe asthma (Chung and al, Eur Respir J 2014), i.e asthma requiring high doses of ICS (>1000 microgram per day of Beclomethasone or equivalent) associated with LABA and/or systemic corticosteroids to be controlled over one year and/or uncontrolled asthma despite the later medications and/or a controlled asthma worsening after decreasing medications Pre-BronchoDilatator (BD) FEV1 <80% of the predicted value at M-1 Documented historical reversibility of FEV1 ≥12% and FEV1 gain ≥ 200 milliliter ACQ-7 score ≥ 1,5 at M-1 and M0 ≥ 3 exacerbations in the 12 months prior to screening visit M-1 Eosinophil blood count ≥ 0,3 G/L at screening visit or in the 12 months prior to the screening visit. If eosinophil blood count is ≥ 0,15 G/L and < 0,3 G/L, an eosinophilic phenotype defined by at least 1 of the following will be required Patients diagnosed with difficult-to-treat asthma and/or with asthma differential diagnosis that have not yet been excluded (vocal cord dysfunction, gastroesophageal reflux disease, granulomatous eosinophilic vasculitis, obstructive sleep apnea syndrome, hyperventilation syndrome, allergic broncho-pulmonary aspergillosis, Carrington disease, Diffuse idiopathic pulmonary neuroendocrine cell hyperplasia (DIPNEC), asthma/ chronic obstructive pulmonary disease (COPD) overlap syndrome) Non-adherent patients to inhaled treatment (ICS + LABA) Active smokers or former smokers exceeding 20 packs year Exacerbation at screening visit M-1 Exacerbation within the past 4 weeks prior to M0, to avoid confounding effects of a short course of systemic corticosteroids that could bias basal molecular signature Active malignancy or malignancy in remission over less than 5 years Active parasitic infection or parasitic infection in the past 24 weeks Hypersensitivity to Benralizumab or to any of the excipients of Fasenra® (histidine, histidine hydrochloride monohydrate, trehalose dihydrate, polysorbate 20) Patients requiring other immunosuppressive and immunomodulator drugs Patients requiring other biotherapy than Benralizumab, with or without French's marketing authorisation in severe asthma
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1
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 18.0-30.0, Muscle Tightness -Age 18-30 Prior history of significant vascular or neuromuscular illness or impairment affecting the lower limbs Serious injuries to the back or legs in the last six months Discomfort or pain in the back or legs Use of pain and anti-inflammatory medications Any contraindications to massage treatment or ultrasound Body mass index (BMI) >30 kg/m2
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0
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