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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 18.0-80.0, Chronic Obstructive Pulmonary Disease (COPD) Obstructive Sleep Apnea Syndrome (OSAS) Men or women between 18 and 80 years old Patient with planned coronary artery bypass graft surgery Patient with planned peripheral vascular surgery Patient with aortic surgery Patient with aortic or mitral valvular replacement Patient with emergency peripheral valvular surgery Patient with emergency coronary artery bypass graft surgery Patient with evolutive malignancy disease Pregnant or lactating women Patient with inadvisable bronchodilator (used for functional respiratory) exploration
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0
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 50.0-80.0, COPD (1) age between 50 and 80 years; (2) a post-bronchodilator forced expiratory volume in one second (FEV1) < 80% of the predicted value and a FEV1/ forced vital capacity (CVF) ratio < 0,7; (3) stable respiratory/clinical condition without changes in medication and symptoms (dyspnea, volume or color of sputum) for at least 4 weeks before admission to the study; and (4) receiving regular treatment with inhaled bronchodilators and steroids (1) presence of other pulmonary, cardiovascular or musculoskeletal diseases; (2) previously participation in any exercise-training program in the last 2 years before participating in this study; and (3) current smokers
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1
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 35.0-85.0, Chronic Obstructive Pulmonary Disease chronic obstructive pulmonary disease GOLD stage III or IV acute exacerbation of the disease contraindications for transcutaneous electrical muscle stimulation
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2
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 18.0-999.0, Floppy Iris Syndrome Male years or older Scheduled for Cataract Surgery Current or Past use of Tamsulosin (flomax) Blue colored iris For controls, no history of Flomax Females Diabetes Glaucoma Use of medicated eye drops Trauma or prior surgery to the eye Black or brown iris
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0
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 40.0-999.0, COPD Method Evaluation Chronic Obstructive Pulmonary Disease Method Evaluation Age greater than or equal to 40 years Male and female Clinical diagnosis of moderate to severe COPD according GOLD guidelines Current or ex smoker with a smoking history equivalent to at least 20 cigarettes smoked per day for 10 years A Modified Medical Research Council (MMRC) dyspnoea scale score of ≥2 FEV1/FVC < 0.7 (post-bronchodilator) FEV1 > 40 % PN and < 70 % PN (post-bronchodilator) Clinical Study Protocol Local Amendment affects UK FEV1 > 30 % PN and < 80 % PN (post-bronchodilator) Current diagnosis of asthma according to GINA guidelines Pregnancy, breast-feeding or planned pregnancy during the study. Fertile women not using acceptable contraceptive measures as judged by the investigator Significant upper or lower respiratory tract infection not fully recovered in the 4 weeks prior to visit 1 Participation in or scheduled for an intensive COPD rehabilitation program Claustrophobia, pacemaker, clips within the brain, previous brain or heart surgery, history of metal in the eye or other MRI contraindication such as obesity or inability to stay in the supine position for 60 minutes
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2
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 50.0-999.0, Benign Prostatic Hyperplasia Is at least 50 years old Has a urinary disturbance associated with severe BPH and has a total IPSS score 20 or higher Has a QoL score of 3 or higher Has a urine volume of 120mL or greater and a Qmax of below 15mL/sec Has a PRV of below 100mL Voluntarily decides to participate in this trial and sign with informed consent form Has been administered silodosin Has been administered an α1A-adrenoceptor blocker within one month Has been prescribed antiandrogens except 5α-reductase inhibitors within a year Has had phytotherapy within 3 months Has had prostatectomy Has had intrapelvic radiation therapy Has had transurethral microwave hyperthermia of transurethral needle ablation Is suspected to have implications that are likely to affect urine passing such as neurogenic bladder, bladder calculus or active urinary tract infection (UTI) Is conducting self-catherterization Has a renal impairment with a serum creatinine of 2.0mg/dL or greater
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0
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 0.0-999.0, Chronic Obstructive Pulmonary Disease people with a read code diagnosis of COPD none
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2
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 40.0-999.0, Chronic Obstructive Pulmonary Disease Age ≥ 40 years at the time of screening Written informed consent and any locally required authorization (eg, HIPAA in the USA, EU Data Privacy Directive in the EU) obtained from the subject prior to performing any protocol-related procedures, including screening evaluations Cohort 1 only: A primary diagnosis of clinically stable physician-diagnosed COPD upon entry into the study meeting one of the following Subjects who have experienced a severe requiring inpatient hospitalization in the previous 12 months Subject who had one severe requiring ED visits in the past 9 months Subjects who are currently on LTOT Cohort 1 only: Stable COPD for 4 weeks prior to screening, as defined by no change in ICS therapy and no use of oral corticosteroids or antibiotics for a respiratory tract infection Cohort 1 only: Forced expiratory volume in one second (FEV1)/forced vital capacity (FVC) < 0.70 or lower limits of normal (LLN) Cohort 1 only: FEV1 < 60% predicted normal value Cohort 2 only: A primary diagnosis of physician-diagnosed requiring admission to the hospital Participation (defined as administration of at least one dose of investigational product) in another clinical study, the last follow-up visit of which is within 12 weeks (for a small molecule drug) and (6 months for a large molecule drug) of entry into this study Any condition that, in the opinion of the investigator would interfere with interpretation of subject safety or study results Employees of the clinical study site or any other individuals involved with the conduct of the study, or immediate family members of such individuals The presence of another chronic pulmonary or systemic disease, which in the opinion of the investigator or medical monitor might affect the analysis of the data (eg, idiopathic pulmonary fibrosis, sarcoidosis, active cancer or autoimmune disease) History of immunodeficiency Current alcohol or drug abuse or a history of unsuccessfully treated alcohol or drug abuse within the past year Cohort 2 only: Diagnosis of an acute disease/condition (eg, congestive heart failure, acute myocardial infarction, pneumonia, or pulmonary embolus) that is the primary reason for the subject's hospitalization
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2
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 18.0-999.0, ST-segment Elevation Myocardial Infarction Thrombus Clinical Patient is > 18 years of age Patient has ST-segment elevation of at least 0.1 mV in 2 or more contiguous leads or presumably new LBBB for all types of infarcts Patient's AMI presentation is greater than 30 minutes but less than 6 hours after symptom onset Patient provides written informed consent. Patient has no childbearing potential or is not pregnant Angiographic All patients with or without evidence of thrombus are eligible Target artery has a reference vessel diameter 2.5 mm on visual assessment at baseline angiography Clinical Known prior history of renal insufficiency (serum creatinine 2.0 mg/dL) Cardiogenic shock Prior administration of thrombolysis for the current infarction Participation in another study Major surgery within past 6 weeks History of stroke within 30 days, or any history of hemorrhagic stroke Severe hypertension (systolic BP > 200 mm Hg or diastolic BP > 110 mm Hg) not controlled on antihypertensive therapy Known neutropenia ( <1000 neutrophils per mm3) or known severe thrombocytopenia (< 50,000 platelets per mm3) Patient unwilling to receive blood products Angiographic
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0
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 40.0-999.0, COPD Dyspnea Hyperinflation Current or former cigarette smokers of at least 10 pack-years Clinically significant dyspnea, as determined by a score of at least 2 on the Medical Research Council Dyspnea Score questionnaire (0-4), or through pulmonary function test results of a residual volume (RV) of > 150% predicted or an FEV1 of <65% predicted Clinical diagnosis of chronic obstructive pulmonary disease Unable to use the slow-breathing device due to hearing impairment Poor motivation or lack of interest in using the device Pulmonary Rehabilitation ordered as a new therapy at the time of enrollment
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2
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 7.0-12.0, Cystic Fibrosis Males and females Age 7-12 years old Diagnosis of cystic fibrosis by sweat chloride > 60 meq/L, or presence of two CFTR mutations known to cause CF Routinely treated with the short-acting bronchodilator albuterol FEV1 > 90% of predicted values FEV1 < 90% of predicted values Routine use of hypertonic saline, mannitol, or amiloride Allergic bronchopulmonary aspergillosis (ABPA) Sputum colonization with Burkholderia cepacia or multiple antibiotic resistant organisms Evidence of a pulmonary exacerbation within past two weeks Treated with intravenous or oral antibiotics in the past two weeks for a pulmonary exacerbation Presence of an acute respiratory illness characterized by Coughing above baseline values Wheezing Respiratory distress
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0
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 50.0-999.0, Benign Prostatic Hyperplasia Males age of 50 years or older diagnosed with symptomatic benign prostatic hyperplasia (BPH) Size, volume,length of prostate
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0
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 40.0-999.0, COPD Diagnosis of moderate to severe stable Chronic Obstructive Pulmonary Disease (COPD) stage II or stage III according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines (2009) Qualifying spirometry, Forced Expiratory Volume in one second (FEV1) and post-bronchodilator FEV1/FVC (Forced Vital capacity) Smoking history ≥ 10 pack years Pregnant women or nursing mothers or women of child-bearing potential not using adequate contraception Cardiac abnormality History of asthma Contraindications to cardiopulmonary exercise testing Participation in active phase of pulmonary rehabilitation program History of cancer within the past 5 years Other protocol-defined inclusion/
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1
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 6.0-99.0, Bronchiolitis Obliterans Diagnosis of BOS after HCT within the 6 months before study enrollment; for this study, BOS is defined as Forced expiratory volume in 1 second (FEV1) < 75% of the predicted normal and FEV1 to slow or inspiratory vital capacity ratio (FEV1/SVC or FEV1/IVC) =< 0.7, both measured before and after administration of bronchodilator OR Pathologic diagnosis of BOS demonstrated by lung biopsy The baseline absolute FEV1 must be >= 10% lower than the pre-transplant absolute FEV1 as defined by the pre-transplant FEV1 minus the baseline FEV1, both measured before administration of a bronchodilator Participant (or parent/guardian) has the ability to understand and willingness to sign a written consent document Recurrent or progressive malignancy requiring anticancer treatment Known history of allergy to or intolerance of montelukast, zafirlukast, azithromycin, erythromycin, or clarithromycin Pregnancy or nursing; all females of childbearing potential must have a negative serum or urine pregnancy test < 7 days before study drug administration Transaminases > 5 X upper limit of normal (ULN) Total bilirubin > 3 X ULN Chronic treatment with any inhaled steroid for > 1 month in the past three months Treatment with montelukast or zafirlukast for > 1 month during the past three months Treatment with prednisone at > 1.2 mg/kg/day (or equivalent steroid) Treatment with rifampin or phenobarbital, aspirin at doses > 325 mg/day, or ibuprofen at doses > 1200 mg/day Treatment with any Food and Drug Administration (FDA) non approved study medication within the past 4 weeks; off-label treatment with an FDA-approved medication is allowed
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0
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 40.0-999.0, Pulmonary Disease, Chronic Obstructive Diagnosis of COPD pack-year or greater history of cigarette smoking Post-bronchodilator FEV1/FVC of <0.7 Predicted FEV1 of 70% of normal or less Modified Medical Research Council (mMRC) dyspnea score of 2 or greater Women who are pregnant, lactating, or planning to become pregnant Respiratory disorders other than COPD, including a current diagnosis of asthma Clinically significant non-respiratory diseases or abnormalities that are not adequately controlled Significant allergy or hypersensitivity to anticholinergics, beta2-agonists, or the excipients of magnesium stereate or lactose used in the inhaler delivery device Hospitalization for COPD or pneumonia within 12 weeks prior to screening Lung volume reduction surgery within 12 weeks prior to screening Abnormal and clinically significant ECG findings at screening Clinically significant laboratory findings at screening Use of systemic corticosteroids, antibiotics for respiratory tract infections, strong cytochrome P450 3A4 inhibitors, high dose inhaled steroids (>1000mcg fluticasone propionate or equivalent), PDE4 inhibitors, tiotropium, oral beta2-agoinists, short- and long-acting inhaled beta2-agonists, ipratropium, inhaled sodium cromoglycate or nedocromil sodium, or investigational medicines for defined time periods prior to the screening visit Use of long-term oxygen therapy (12 hours or greater per day)
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1
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 40.0-999.0, Pulmonary Disease, Chronic Obstructive Diagnosis of COPD pack-year or greater history of cigarette smoking Post-bronchodilator FEV1/FVC of <0.7 Predicted FEV1 of 70% of normal or less Modified Medical Research Council (mMRC) dyspnea score of 2 or greater Women who are pregnant, lactating, or planning to become pregnant Respiratory disorders other than COPD, including a current diagnosis of asthma Clinically significant non-respiratory diseases or abnormalities that are not adequate controlled Significant allergy or hypersensitivity to anticholinergics, beta-agonist, or the excipients of magnesium stereate or lactose used in the inhaler delivery device Hospitalization for COPD or pneumonia within 12 weeks prior to screening Lung volume reduction surgery within 12 weeks prior to screening Abnormal and clinically significant ECG findings at screening Clinically significant laboratory findings at screening Use of systemic corticosteroids, antibiotics for respiratory tract infections, strong cytochrome P450 3A4 inhibitors, high dose inhaled steroids (>1000mcg fluticasone propionate or equivalent), PDE4 inhibitors, tiotropium, oral beta2-agoinists, short- and long-acting inhaled beta2-agonists, ipratropium, inhaled sodium cromoglycate or nedocromil sodium, or investigational medicines for defined time periods prior to the screening visit Use of long-term oxygen therapy (12 hours or greater per day)
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1
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 40.0-80.0, Chronic Obstructive Pulmonary Disease age 40-80 years old cases: spirometry (post-bronchodilator) based diagnosis of COPD (GOLD criteria) + smoking history of at least 10 pack-years and active smoking behavior till at least 10 years from the moment of enrollment. smoking controls: no COPD (spirometry based) + smoking history of at least 10 pack-years and active smoking behavior till at least 10 years from the moment of enrollment. non-smoking controls: no COPD (spirometry based) + < 1 pack year Respiratory disorder other than COPD α1-antitrypsin deficiency Known history of significant inflammatory disease other than COPD COPD exacerbation within 4 weeks prior to study Lung surgery Recent diagnosis of cancer Therapy with oral corticosteroids in the last 6 weeks Significant cardiovascular comorbidity Significant orthopedic/musculoskeletal problems
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1
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 50.0-999.0, Arterial Hypertension adults, 50 years of age or older with changing blood pressure (bp) with or without drugs and patients with uncontrolled bp despite drugs An average systolic bp on 2 of the 3 previous visits of 140 mm Hg or more (130 mm Hg for diabetics) and an average diastolic bp of 80 to 100 mm Hg Blood analysis (fasting glycaemia, creatinin, total cholesterol, high density lipoprotein cholesterol) in the last 6 months At least 3 of the following using table salt 3/weeks consumption of prepared meals (butchery, warehouse...) 3/weeks consumption of effervescent tablet Daily consumption of cheese/cold cuts Daily consumption of salted butter/margarine heart failure renal insufficiency secondary hypertension isolated systolic/diastolic hypertension bp difference of more than 10 mm Hg between left and right arm lactation or pregnancy active malignancy an active 'low in salt' diet changing the use of antihypertensive drugs or other medication that would affect bp for the last 4 weeks impaired cognitive functioning$
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0
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 45.0-80.0, Obstructive Chronic Pulmonary Disease Emphysema Patients with COPD diagnosed according to established by the A.. TS (American Thoracic Society) and the SEPAR (Spanish Society of Pneumology and Thoracic Surgery) to submit a modereda-severe obstruction to airflow. (FEV1 <60%) and a clinical impact of their disease other cardiorespiratory diseases Systemic diseases Inability or discomfort to participate in an exercise program
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2
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 21.0-70.0, Pulmonary Disease, Chronic Obstructive A subject will be eligible for in this study only if all of the following apply All volunteers must be aged between 21 to 70 years inclusive and be competent to understand and give informed consent All female volunteers of child bearing potential must have provided a negative pregnancy test before and prior to any HRCT scan Body weight < 120 kg and BMI within the range 18 kg/m2 (inclusive) Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form Available to complete the study Subject will then be included only if they fulfil all for the following relevant cohort Healthy: Cohort Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history and physical. A subject with a clinical abnormality or parameters outside the reference range for the population being studied may be included if the Investigator agrees that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures Non-smokers (never smoked or not smoking for >12 months with <1 pack year history) (Pack years = (cigarettes per day smoked/20) x number of years smoked)) A subject will not be eligible for in this study if any of the following apply As a result of the medical interview, physical examination or screening investigations, the physician responsible considers the volunteer unfit for the study Any pregnant female Volunteers who have a past or present disease, which as judged by the Investigator, may affect subject safety or influence the outcome of the study The subject has received an investigational drug or participated in any other research trial within 30 days or five half-lives, or twice the duration of the biological effect of any drug (whichever is longer) The subject that has both asthma and COPD Previous in a research and/or medical protocol involving nuclear medicine Any Radiological investigations with significant radiation burden (a significant radiation burden being defined as ICRP category IIb or above: No more than 10 mSv in addition to natural background radiation, in the previous 3 years including the dose from this study) The subject has a history of alcohol or drug abuse The subject has had a respiratory tract infection within four weeks of the start of the study
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1
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 18.0-999.0, Hypertension, Pulmonary Pulmonary Disease, Chronic Obstructive Age ≥ 18 years Known or newly diagnosed COPD or PAH Written informed consent Present long-term oxygen treatment is no criterion Age < 18 years Right-heart catheterization not reasonable Pregnancy, Lactation Life expectancy <12 months due to any diseases aside from COPD Any medical, psychological or other condition, which limits the patient's ability to provide informed consent No written informed consent provided Current participation in another clinical trial
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2
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 50.0-999.0, Osteoarthritis Clinical diagnosis of osteoarthritis of the knee or hip that requires treatment American Rheumatism Association (ARA) functional Class I, II or III Receiving a stable dose of a traditional non-steroidal anti-inflammatory drug (NSAID), a Cox-2 selective inhibitor (other than etoricoxib, e.g. celecoxib), opioid therapy or tramadol to treat their osteoarthritis-related pain for at least 2 weeks and willing to maintain treatment during baseline phase Moderate to severe daily pain intensity on his or her current pain regimen Excepting osteoarthritis, patient is judged to be in otherwise general good health based on medical history, physical examination, and routine laboratory tests Negative serum pregnancy test Has not experienced at least 3 consecutive days of daily pain intensity >4 on 10-point scale Severe hepatic insufficiency Advanced renal insufficiency Presence of gastro-intestinal ulcer disease with active bleeding or history of the same within the past 6 months or a presence or history of inflammatory bowel disease History of gastric, biliary (including gastric bypass surgery), or small intestinal surgery that results in clinical malabsorption Receiving or will likely require treatment with ≥14 consecutive days or repeated courses of pharmacologic doses of corticosteroids Established ischemic heart disease, peripheral arterial disease, and/or cerebrovascular disease including a history of stroke, myocardial infarction or transient ischemic attack, and recent revascularization procedures Any other contraindications mentioned in the approved study drug European Union (EU) Summary of Product Characteristics (SmPC) Therapy with glucosamine and/or chondroitin sulfate for <6 months prior to study start
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0
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 18.0-999.0, Migraine Disorders Respondents age 18 or older at the time of survey completion Respondents completed the questionnaires in 2004 and at least one other year (2005, 2006, 2007, 2008, 2009) Based on the respondents answers to the 2004 survey, their symptoms meet the for EM which is characterized by headaches meeting International Classification of Headache Disorders (ICHD-2) for migraine 1-14 days a month Responses to questions suggest that the respondent's diagnosis is not migraine or CM
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0
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 45.0-75.0, Chronic Obstructive Pulmonary Disease Age 45 through 75 years Predicted (Global Initiative for Chronic Obstructive Lung Disease [GOLD] stage II, III, and IV) at Screening History of previous acute exacerbations of chronic obstructive pulmonary disease (AECOPD) 12 months prior to Screening Clinically stable and free from an for 8 weeks prior to Day 1 Current smoker or ex-smoker with a tobacco history of more than or equal to (>=) 10 pack-years Past or present disease or disorder Significant or unstable ischemic heart disease etc Known history of allergy or reaction to any component of the investigational manufacturing product (IMP) Past or current malignancy within the past 5 years Subjects have had a chest x-ray or Computed Tomography (CT) scan suggestive of malignancy or tuberculosis (TB) Use of immunosuppressive medication receipt of any biologic agent
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1
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 50.0-999.0, Chronic Obstructive Pulmonary Disease Dyspnea Men and women over 50 years with a diagnosis of COPD stage II and III according to GOLD classification, performed spirometry Patients who manifest dyspnea on MRC Patients SGSS affiliates COPD controlled, verified medical history Voluntary participation in informed consent Higher mental functions altered Degenerative musculoskeletal diseases (acute state) Multisystem disease not controlled Perform a current fitness program
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1
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 40.0-999.0, Chronic Obstructive Pulmonary Disease (COPD) Inflammatory Disease Endothelial Dysfunction presence of COPD according to standard acute exacerbation of COPD according to recommended international over 40 years of age history of at least 10 py pneumonia history or signs of congestive heart failure acute myocardial infarction thoracotomy incl. resection of lungtissue interstitial lung disease acute or chronic renal failure active malignancy autoimmune disease
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2
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 0.0-999.0, Pulmonary Emphysema COPD Lung Diseases Willing and able to provide informed consent and to participate in the study Diagnosis of advanced emphysema (GOLD Stage III or Stage IV disease) Radiologic evidence of non-bullous upper lobe predominant heterogeneous emphysema with at least 2 target sites deemed appropriate for treatment evident by CT imaging DLco between 20 and 60% predicted Positive Collateral Ventilation as determined by the Chartis® System Clinically significant dyspnea (defined as a MRC dyspnea score of 2 or greater at Screening) Failure of standard medical therapy to provide adequate relief of symptoms (defined as regular use of standard medication for more than 1 month prior to Screening; standard medications at least an inhaled beta agonist and inhaled anticholinergic unless medically contraindicated or prior medical failure) Significant airflow obstruction as demonstrated by Spirometry 15 minutes after administration of bronchodilator with < FEV1 < 50% predicted using the ATS recommended calculation for expected value FEV1/FVC ratio <70% Alpha-1 antitrypsin serum level of < 80 mg/dL (i.e. < 11 micro mol/L) at Screening Body mass index < 15 kg/m2 or > 35 kg/m Clinically significant asthma, chronic bronchitis or bronchiectasis as determined by the Investigator, or a significant COPD exacerbation within the past 4 months Use of systemic steroids > 20 mg/day or equivalent immunosuppressive agents, heparins, oral anticoagulants (e.g., warfarin, dicumarol; note: antiplatelet drugs including aspirin and clopidogrel are permitted) or investigational medications within 4 weeks of Screening Allergy or sensitivity to medications required to safely perform AeriSeal System treatment under general anesthesia or conscious sedation Participation in an investigational study of a drug, biologic, or device not currently approved for marketing within 30 days prior to the Screening visit Prior lung volume reduction surgery, prior lobectomy or pneumonectomy, prior lung transplantation, prior airway stent placement, prior pleurodesis, or prior endobronchial lung volume reduction therapy of any type Significant co-morbidity that carries prohibitive risks (e.g., HIV/AIDS, cancer) or is associated with less than 2-year expected survival Blood gases and oxygen saturation SpO2 ≤ 90% on > 4 L/min supplemental O2, at rest
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1
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 0.0-999.0, COPD Emphysema Small Airway Disease clinical diagnosis COPD according to last updated GOLD guidelines (post- bronchodilator FEV/FVC below 0,70, FEV1 <80% predicted) ex-smokers (ie 1 year from the last cigarette) with at least 10 pack years GOLD stage II and III (FEV1 > 30% predicted) by preference naïve to inhaled corticosteroids; in those taking inhaled corticosteroids this medication will be stopped 1 month prior to enrollment in the study Patients must have proven small airways dysfunction on routine spirometry as reflected by a drop in FEF25-75 and FEF75 of at least 50%. Moreover, patients must have proven small airways dysfunction on MBW as reflected by Sacin >0,120 that is considered abnormal Current smoking Active COPD exacerbation gold stage I and IV
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1
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 40.0-75.0, Chronic Obstructive Pulmonary Disease Male or female aged 40-75 years inclusive at the time of signing the informed consent Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form COPD diagnosis: Subjects with a diagnosis of COPD as defined by the American Thoracic Society (ATS)/European Respiratory Society (ERS) guidelines, with symptoms compatible with COPD for at least 1 year prior to screening Severity of Disease: subjects who conform to the current severity classification for GOLD Stage II/III disease in terms of post-bronchodilator spirometry at screening (Post-salbutamol FEV1/FVC ratio of ≤ 0.70 and post-salbutamol FEV1 ≥ 40 % and ≤ 80 % of predicted normal values calculated using ECCS reference equations) Demonstrated ability to use the I-neb AAD system at screening Subject is a current or previous smoker with a smoking history of ≥ 10 pack years A history of life-threatening COPD including Intensive Care Unit admission and/or requiring intubation A history of > 1 hospitalisation for COPD in the previous 2 years prior to screening Evidence of cor pulmonale or clinically significant pulmonary hypertension or chronic (in the opinion of the Investigator) use of oxygen Upper or lower respiratory tract infection, including exacerbation of COPD, within 6 weeks of screening Other respiratory disorders: Subjects with a current diagnosis of asthma, active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, interstitial lung diseases or other active pulmonary diseases Subjects with a history of chronic disease including, but not limited to, sleep apnoea, cardiovascular, endocrine, neurological, hepatic, gastrointestinal, renal, hematological, urological, immunological, or ophthalmic diseases that the Investigator believes are clinically significant Previous lung resection or lung reduction surgery Pregnant or nursing females Any abnormal or clinically significant ECG or laboratory values that the Investigator considers would put the subject at risk through participation. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included if the Investigator and the sponsor representative agree it is unlikely to introduce additional risk factors and will not interfere with study procedures ALT > 2 x ULN at the screening visit
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1
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 5.0-24.0, HIV-infection/Aids HIV seropositive diagnosed with standard techniques 2. Age for PA Group: 5.0 to 24.9 y 3. Age for BA Group: 15.0 to 24.9 y 4. In usual state of good health (no hospitalizations, emergency room or unscheduled acute illness visits for 2 weeks prior to enrollment) 5. Subject and/or family commitment to the 12-month study Other chronic health conditions that may affect growth, dietary intake, and/or nutritional status 2. Pregnancy 3. Participation in another HIV intervention study with impact on 25D serum concentrations 4. Use of vit D3 supplementation for the purpose of treating vit D deficiency 5. Use of vit D3 supplementation not part of a prescribed treatment plan for vit D deficiency (subjects willing to discontinue supplementation will become eligible after a minimum of a 2 month washout period) 6. Non-English Speaking
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0
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 40.0-999.0, Pulmonary Disease, Chronic Obstructive All patients must sign an informed consent consistent with International Conference on Harmonization Good Clinical Practice (ICH-GCP) guidelines prior to participation in the trial and conducting any study procedures. 2. Male or female patients 40 years of age or older. 3. Ability to independently read and understand English and/or Spanish. 4. Any self-reported history of smoking (e.g. = 100 cigarettes (~5 packs) during life-time). 5. Acute respiratory symptoms for up to 7 days 6. All patients must have a diagnosis of COPD, and must have an airway obstruction with a post-bronchodilator (Forced Expiratory Volume in 1 second (FEV1)/Forced Vital Capacity (FVC)) <0.7. The diagnosis of COPD can be made at Visit 1. 7. The clinical assessment of the enrolled patient in the judgement of the investigator supports the introduction of COPD maintenance therapy. 8. Patients must be able to inhale medication in a competent manner from the HandiHaler® device and from a metered dose inhaler (MDI) Therapy with any long-acting bronchodilator, short-acting anticholinergic, inhaled corticosteroid or regular maintenance use (>14 consecutive days) of systemic corticosteroid (the latter for respiratory indications) during the previous 6 months (short course of systemic corticosteroid for up to 14 days for respiratory indications allowed); in case of use of systemic corticosteroid medication for other than respiratory conditions, then of unstable doses (i.e., less than six weeks on stable dose) or at doses in excess of the equivalent of 10 mg prednisolone-equivalent per day. In addition, daily use of short-acting beta2-agonist for more than a week prior to Visit 0 not allowed. The following apply at Visit 1: 2. Significant diseases other than COPD. A significant disease is defined as a disease or condition which, in the opinion of the investigator, may put the patient at risk because of participation in the study or may influence the patient¿s ability to participate in the study. 3. A recent history (i.e., six months or less) of myocardial infarction. Patients being stable with a history of cardiac stents prior to six month are permitted. 4. Any unstable or life-threatening cardiac arrhythmia requiring intervention or change in drug therapy during the last year. 5. Hospitalisation for cardiac failure (New York Heart Association (NYHA) Class III or IV) during the past year. 6. Any significant or new ECG findings at V1 as judged by the investigator, including, but not limited to signs of ischemia, arrhythmia, heart failure, or the report of chest pain. 7. Known active tuberculosis. 8. Current asthma (patient treated for asthma in the last 2 years), cystic fibrosis, clinical diagnosis of bronchiectasis, interstitial lung disease, or pulmonary thromboembolic disease. 9. A history of thoracotomy with pulmonary resection. Patients with a history of thoracotomy for other reasons should be evaluated as per criterion no. 2. 10. Malignancy for which the patient has undergone resection, radiation, chemotherapy or biological treatments within the last year or is currently on active radiation therapy, chemotherapy or biological treatment. Patients with treated basal cell carcinoma are allowed. 11. At visit 0 or 1, a severe respiratory infection, e.g. pneumonia (as suspected by investigator), any condition or exacerbation requiring ER visit or hospitalization, need for oxygen treatment. 12. Known hypersensitivity to anticholinergic drugs, lactose, or any other components of the HandiHaler® or MDI inhalation solution delivery system. 13. Treatment with any restricted pulmonary medication 14. Requirement of supplemental oxygen therapy for = 24 hours during the previous 6 months. 15. Known moderate to severe renal impairment. 16. Known narrow angle glaucoma. 17. Significant symptomatic prostatic hyperplasia or bladder-neck obstruction. Patients whose symptoms are controlled on treatment may be included. 18. Pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception (i.e., oral contraceptives, intrauterine devices, diaphragm or subdermal implants e.g., Norplant®) for at least three months prior to and for the duration of the trial. 19. Significant alcohol or drug abuse within the past 12 months. 20. Actively participating in a pulmonary rehabilitation program. 21. Previously randomized in this study or currently participating in another interventional study. 22. Visual impairment that as judged by the investigator does not allow the patient to independently read and complete the questionnaires and electronic diary (eDiary)
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2
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 40.0-999.0, COPD Provision of informed consent prior to any study specific procedures Male or female of non-childbearing potential (post-menopausal or surgically sterilised), age ≥40 years at Visit 1 Clinical diagnosis of COPD for more than 1 year at Visit 1, according to GOLD guidelines Post-bronchodilator FEV1 ≥ 40 to < 80% of the predicted normal value and post-bronchodilator FEV1/FVC < 70% Reversible airway obstruction Significant disease or disorder which, in the opinion of the Investigator, may either put the patient at risk because of participation in the study, or influence the result of the study, or the patient's ability to participate in the study An exacerbation of COPD within 6 weeks prior to Visit 1 Treatment with systemic glucocorticosteroids with 6 weeks of Visit 2 Recent or ongoing respiratory tract infection during enrolment period Need for long-term oxygen therapy and/or saturation O2 < 92%
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1
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 18.0-999.0, Benign Prostatic Hyperplasia (BPH) male over the age of 18 years present with symptomatic/ obstructive symptoms secondary to PBH requiring surgical intervention subjects must read, understand and sign the Informed Consent AUA ≥ 15 Qmax < 15mL/sec Stopped BPH medication. Alpha blockers 15 days 5-α-reductase 3 months Prostate volume ≥ 30g PVR > 300ml Current urine retention Previous surgical or invasive treatments (TURP, TUMT, TUNA) PSA ≥ 4 (must have negative biopsy within last 12 months) Neurogenic bladder Obstruction due to urethral stricture Any disorder or condition of the subject that the investigator believes will counter indicate their in the study
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0
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 50.0-999.0, Exudative Age-related Macular Degeneration subfoveal or juxtafoveal CNV owing to AMD, defined by fluorescein angiography (FA) presence on SD-OCT of subretinal or intraretinal fluid associated or not with macular edema Best corrected visual acuity (BCVA) in the study eye between 20/20 and 20/125, inclusive total area of the lesion (including blood, neovascularization and scar/atrophy) of ≤8 disc areas, of which at least 50% must be active choroidal neovascularization (CNV) (defined as the neovascular component of the lesion as defined by FA all angiographic subtypes [predominantly classic, minimally classic and occult] were eligible) clear ocular media and adequate pupillary dilatation to allow collection of fundus photographs and FA of a sufficient quality to be analyzed intraocular pressure of 21 mmHg or less and no previous treatment for AMD presence of scarring or atrophy >75% of the total lesion size (patients with subfoveal scar or atrophy were excluded) subretinal haemorrhage >75% of the total lesion size; presence of serous retinal pigment epithelial detachments >5 disc areas presence of intraocular inflammation (≥ trace cell or flare), epiretinal membrane, macular hole or vitreous haemorrhage history of idiopathic or autoimmune-associated uveitis in either eye significant media opacities, including cataract, which might interfere with VA, assessment of toxicity or fundus photography in the study eye presence of other causes of CNV, including pathological myopia (spherical equivalent of -3 diopters or more, or axial length of 25 mm or more, or fundus findings suggestive of pathologic myopia), ocular histoplasmosis syndrome, angioid streaks, choroidal rupture and multifocal choroiditis any retinal treatment (aside from antioxidants), including (but not limited to) intravitreal injections, photodynamic therapy with verteporfin, laser photocoagulation or surgery history of rhegmatogenous retinal detachment, pars plana vitrectomy or corneal transplant and previous radiation in the region of the study eye
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0
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 18.0-45.0, Healthy Is the individual a healthy, normal adult man or woman who volunteers to participate? Is s/he within 18 to 45 years of age, inclusive? Is his/her BMI between 19 and 30 inclusive? Is she willing to avoid pregnancy by abstaining from sexual intercourse with a non-sterile male partner, or by the use one of the following methods: diaphragm + spermicide or condom + spermicide (at least 14 days before dosing), intra-uterine contraceptive device or hormonal contraceptives (at least 4 week prior to dosing) or has she been surgically sterile or post-menopausal at least six months prior to entering into the study? Is s/he considered reliable and capable of understanding his/her responsibility and role in the study? Has s/he provided written informed consent? Does the individual have a history or allergy or hypersensitivity to desloratadine or pseudoephedrine, milk or eggs? Does s/he have clinically significant laboratory abnormalities that would interfere with the conduct or interpretation of the study or jeopardize his/her safety? Does s/he have significant history or clinical evidence of auto-immune, cardiovascular, gastrointestinal, hematological, hematopoietic, hepatic, neurological, ongoing infection, pancreatic, or renal disease that would interfere with the conduct or interpretation of the study or jeopardize his/her safety? Is she nursing? Does s/he have serious psychological illness? Does s/he have significant history (within the past year) or clinical evidence of alcohol or drug abuse? Does s/he have a positive urine drug screen or a positive HIV-I, or hepatitis B or C screen, or a positive pregnancy test? Is s/he unable to refrain from the use of alcohol or xanthine-containing foods or beverages during periods beginning 48 hours prior to study drug administration and ending when the last blood sample has been taken in each study period? Has s/he used any prescription drug, other than hormonal contraceptives, during the 14 day period prior to study initiation, or any OTC drug during the 72 hour period preceding study initiation? Is s/he unable to refrain from the use of all concomitant medications, other than hormonal contraceptives, during the study?
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0
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 21.0-999.0, Chronic Illness All adult patients at the age of 21 or above with chronic illness and given written informed consent Subjects must be available to complete the study and comply with study procedures. Willingness to allow for serum samples to be stored beyond the study period, for potential additional future testing to better characterize immune response Clinically significant immune-related diseases or significant recent co-morbidities Inability to comprehend and to follow all required study procedures History or any illness that might interfere with the results of the study or pose additional risk to the subjects due to participation in the study Have received 2011/2012 TIV Have a recent history (documented, confirmed or suspected) of a flu-like disease within a week of vaccination Have a known allergy to eggs or other components of the Study Vaccines (including gelatin, formaldehyde, octoxinol, thimerosal, and chicken protein), or history of any anaphylaxis, serious vaccine reactions, to any excipients Have a positive urine or serum pregnancy test within 24 hours prior to vaccination, or women who are breastfeeding Female of childbearing potential, not using any acceptable contraceptive methods for at least 2 months prior to study entry or that do not plan to use acceptable birth control measures during the first 3 weeks after vaccination Have immunosuppression as a result of an underlying illness or treatment, or use of anticancer chemotherapy or radiation therapy (cytotoxic) within the preceding 36 months Have an active neoplastic disease or a history of any hematologic malignancy
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0
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 55.0-999.0, Osteoarthritis of the Knee Coagulopathy Male or female adults > than or equal to 55 Ambulatory subjects with moderate to severe osteoarthritis (OA) of the knee with symptoms and knee pain for at least 3 months and pain on the majority of days in the last 30 days Subjects with bilateral knee OA, the more symptomatic knee is the index knee and can be applied on both knees if both are affected Radiographic evidence of Kellgren-Lawrence Grade 2-4 within the past 2 years Currently on a stable dose of anticoagulant therapy (warfarin, dabigatran, aspirin or clopidogrel) for the past 2 months and expected to remain on current dose for the six week duration of the study If currently taking oral nonsteroidal antiinflammatory drug (NSAID) and/or acetaminophen for OA knee pain, must be taking it for at least an average of 25 days per month Those currently taking oral NSAID must be willing to perform a 7 day washout to be eligible to be enrolled into the study A pain score of > than 40mm on the Patient Pain Visual Analog Scale (VAS) (100 mm scale) at screening and baseline visit Able to comply with the study and give informed consent prior to performance of any study procedures Able to read, write and understand English Unwilling to abstain from oral NSAIDs and/or other analgesic medication except for acetaminophen as rescue medication. Subjects taking low dose aspirin for cardiovascular health may remain on their stable dose throughout the study Unwilling to abstain from taking < than or equal to 1500mg of acetaminophen a day for rescue medication purposes during the 6 week course of the trial Using a handicap assistance device i.e. cane, walker > than or equal to 50% of the time Undergoing new physical therapy or participating in a weight loss or exercise program that has not been stable for at least 3 months prior to screening and won't remain stable during participation in study History or diagnosis of an inflammatory arthritis i.e. rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, arthritis associated with inflammatory bowel disease, sarcoidosis, or amyloidosis Known or clinically suspected infection and human immunodeficiency virus (HIV), or hepatitis C or B viruses History of abnormal laboratory results > that or equal to 2.5 x upper limit of normal (ULN) indicative of any significant medical disease which in the opinion of the investigator, would preclude the subjects participation in the study Any of the following abnormal laboratory results during screening Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) > than or equal to 2.5 x ULN Hemoglobin < than 11.5 g/dL (female) or < 13.2 g/dL (male)
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0
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 0.615-0.769, Prematurity Sepsis SGA RDS Premature infants diagnosed with SGA, RDS and/or Sepsis >32 weeks Referred by Neonatologist IRB HIPPA Informed Parent for infant consent obtained in writing Infants with diagnoses other than the above
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0
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 40.0-999.0, Pulmonary Disease, Chronic Obstructive Exacerbation of COPD Age > 40 years Capability to use the devices provided Willing to participate • Participation in a previous COPD home telehealth study
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2
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 16.0-999.0, Influenza Adult patients ≥ 16 years of age admitted to participating SOS Network hospitals with the following admitting diagnoses will be eligible for screening pneumonia acute exacerbation of chronic obstructive pulmonary disease (AECOPD) or asthma unexplained sepsis Any other respiratory infection or diagnosis Or any respiratory or influenza-like symptom )(eg dyspnea, cough, sore throat, myalgia, arthralgia, fever, delirium/altered level of consciousness, CHF) Patients whose reason for admission was clearly unrelated to the presence of influenza (for example, patients admitted due to trauma, elective surgery, or patients who have an alternative diagnosis that is clearly not respiratory,, e.g. cellulitis, intra-abdominal process, or gastrointestinal bleeding) Unless being enrolled as a nosocomial influenza case Patients whose onset of symptoms was prior to or within 72 hours of hospital admission but who were not tested for influenza within 7 days of hospital admission. These should be captured on the screening form as screen failures No children in care will be enrolled in the study
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0
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 18.0-999.0, Chronic Obstructive Pulmonary Disease (COPD) Decompensated COPD With (Acute) Exacerbation Patients with Chronic Obstructive Pulmonary Disease Age > 18 years Hospitalized in Intensive care for an acute exacerbation Requiring Non invasive mechanical ventilation Able to breath spontaneously without non invasive ventilation more than 4h/day Without bulbar dysfunction Hemodynamic instability Absence of consent Severe Hypoxemia pH < 7,30 No cooperation of the patient
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2
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 0.0-999.0, Chronic Obstructive Pulmonary Disease clinical diagnosis of moderate to severe chronic obstructive pulmonary disease (COPD) a minimum of two: Emergency Department admissions; hospital admissions or emergency GP contacts in the 12 months previous to the study any respiratory disorder other than COPD patients cognitively unable to learn the process of monitoring
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2
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 50.0-999.0, Benign Prostatic Hyperplasia Possess a clinical diagnosis of BPH Able to read, understand, and complete the study questionnaire History or recurrent evidence of any condition, therapy, lab abnormality or other circumstance that might confound the results of the study, or interfere with participation for the full duration of the study History of malignancy ≤ 5 years prior to signing informed consent, except for adequately treated basal cell or squamous cell skin cancer, including prostate cancer of any duration, evidence or suspicion of prostate cancer on a previous biopsy History of prostatic surgery or other invasive procedures to treat BPH or history of bladder neck obstruction, bladder cancer, and/or pelvic irradiation, urinary incontinence, recurrent urinary tract infection, urethral stricture, or bacterial prostatitis History of acute urinary retention (ie, inability to fully empty bladder) Had invasive urinary bladder procedures (ie, cystoscopy) within 7 days prior to screening Had phytotherapy within 2 weeks of screening and may need phytotherapy during the study History of low blood pressure (orthostatic hypotension, hypotension [supine blood pressure less than 90/70 mm Hg]), unstable angina, or a cardiovascular or cerebral vascular event (ie, transient ischemic attack [TIA], stroke) within the previous 3 months prior to enrollment, OR a history of dizziness, vertigo or any other typical signs and symptoms of low blood pressure Recent history (ie, within the past year) or active addiction, abuse, misuse of and/or dependence on drugs and/or alcohol Use of herbal therapies that may impact the study (eg, Saw Palmetto) within 2 weeks of screening and/or is predicted to need herbal therapies during the study. Individuals currently taking herbal therapies may be eligible for study if willing to complete a 2-week washout period Use of finasteride or a drug with a similar action during the 12 months prior to study screening. Individuals treated for short periods with 5-alpha reductase inhibitors (5ARIs) or drugs with antiandrogenic properties within 12 months of screening may be eligible for study
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0
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 40.0-999.0, Pulmonary Disease, Chronic Obstructive Diagnosis of chronic obstructive pulmonary disease. 2. Relatively stable airway obstruction with post FEV1< 80% predicted normal and post FEV1/FVC <70%. 3. Male or female Japanese patients, 40 years of age or older. 4. Smoking history of more than 10 pack years Significant disease other than COPD 2. Clinically relevant abnormal lab values. 3. History of asthma. 4. Diagnosis of thyrotoxicosis 5. Diagnosis of paroxysmal tachycardia 6. History of myocardial infarction within 1 year of screening visit 7. Unstable or life-threatening cardiac arrhythmia. 8. Hospitalization for heart failure within the past year. 9. Known active tuberculosis. 10. Malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years 11. History of life-threatening pulmonary obstruction. 12. History of cystic fibrosis. 13. Clinically evident bronchiectasis. 14. History of significant alcohol or drug abuse. 15. Thoracotomy with pulmonary resection 16. Oral ß-adrenergics. 17. Oral corticosteroid medication at unstable doses 18. Regular use of daytime oxygen therapy for more than one hour per day 19. Pulmonary rehabilitation program in the six weeks prior to the screening visit 20. Investigational drug within one month or six half lives (whichever is greater) prior to screening visit 21. Known hypersensitivity to ß-adrenergic drugs, anticholinergics, BAC, EDTA 22. Pregnant or nursing women. 23. Women of childbearing potential not using a highly effective method of birth control 24. Patients who are unable to comply with pulmonary medication restrictions 25. Patients with narrow-angle glaucoma or micturition disorder due to prostatic hyperplasia etc
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1
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 18.0-999.0, Assess the Patient Feeling About the Handiness of Two Different Vials Used to Deliver Both, Unpreserved Hyaluronic Eye Drops Man or woman aged 18 and older Patient with dry eye for at least 3 months Having given his written informed consent Intolerance to studied products Patient's inability to understand the study procedures and give informed consent Patient unwilling to follow the study procedures and visits defined by the protocol Pregnant or lactating women Patient under guardian ship
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0
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 40.0-999.0, Chronic Obstructive Pulmonary Disease (COPD) Male or female adults aged ≥40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure With moderate to severe stable COPD (Stage II or Stage III) Current or ex-smokers who have a smoking history of at least 10 pack years (Ten pack- years are defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20 years) Post-bronchodilator FEV1 ≥30% and < 80% of the predicted normal, and post-bronchodilator FEV1/FVC < 0.7 at Visit 2 (Day -14) (post means: record FEV1 and FVC 45 min after administering ipratropium) Symptomatic patients, according to daily electronic diary data between Visit 2 (Day -14) and Visit 3 (Day 1), with a total score of 1 or more on at least 4 of the last 7 days prior to Visit 3 With a history of malignancy of any organ system (including lung cancer), treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin Patients with any history of asthma indicated by (but not limited to) a blood eosinophil count > 600/mm3 (at Visit 2) or onset of symptoms prior to age 40 years. Patients without asthma but who have a blood eosinophil count >600/mm3 at Visit 2 are excluded Patients with concomitant pulmonary disease, e.g. pulmonary tuberculosis (unless confirmed by imaging to be no longer active) or clinically significant bronchiectasis, sarcoidosis and interstitial lung disorder Patients with lung lobectomy or lung volume reduction or lung transplantation Patients with known history and diagnosis of α-1 antitrypsin deficiency Patients who have had a COPD exacerbation that required treatment with antibiotics, systemic steroids (oral or intravenous) or hospitalization in the 6 weeks prior to Visit 1 Patients who have had a respiratory tract infection within 6 weeks prior to Visit 1. Other protocol-defined inclusion/
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1
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 0.0-0.038, Feeding Disorder Nutrition Disorder Infant,Premature Weight below 1250 grams 2. Age less than 14 days 3. Feeding intolerance; If feeding residual more than 30% on q3 hr feeding; 5 times out of 8 times, feeding residual more than 20% on q4 hr feeding 4 feeding out of 6 feeding or failure to advance feeding of more than 20ml/kg in 72 hrs GI malformation or perforation 2. Genetic disorder 3. Parents can't read English. After consent, if infants meet he would be allowed to receive one of the following three medication. 1) Erythromycin at 1mg/kg/dose q8 hr 2) Metoclopramide 0.1mg/kg/dose q8 hrs and Placebo. If infant fails to get better, he would be crossover to one of the remaining two
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0
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 19.0-999.0, Heart Failure Heart Diseases Cardiovascular Diseases Duke University Hospital inpatient adults Hospitalization for acute decompensated heart failure Dyspnea (shortness of breath) at rest or minimal exertion plus at least 1 sign of volume overload Previous heart failure hospitalization within the past 1 year At significant risk of dying from heart failure in the next 6 months Anticipated discharge from hospital with anticipated ability to return to outpatient follow-up appointments Are not an inpatient at Duke University Hospital Acute coronary syndrome within 30 days Cardiac resynchronization therapy (CRT) within the past 3 months or current plan to implant CRT device Active myocarditis, constrictive pericarditis Severe stenotic valvular disease amenable to surgical intervention Anticipated heart transplant or ventricular assist device within 6 months Renal replacement therapy Non-cardiac terminal illness Women who are pregnant or planning to become pregnant Inability to comply with study protocol
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0
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 18.0-999.0, Knee Osteoarthritis Post-TKA active range of motion: flexion 80º and extension -10º ABsence of stiffness Ability to walk with the use of a walking aid Ability to read and understand Spanish Ability to understand and accept the trial procedures and to sign an informed consent form in accordance with national legislation Sensory, cognitive and/or praxic impairment Concomitant medical conditions that may influence the rehabilitation process Discharge destination other than home Patients with any local or systemic complication (e.g., surgical wound infection, suspicion of deep vein thrombosis…) in the three-month follow-up period
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0
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 40.0-999.0, Pulmonary Disease, Chronic Obstructive at least 40 years of age at index date continuously eligible to receive healthcare services through Medicaid in the pre-index and follow-up period enrolled in fee-for-service plans without a diagnosis code of exclusionary comorbid conditions cystic fibrosis, bronchiectasis, respiratory cancer, pulmonary fibrosis, pneumoconiosis, sarcoidosis, pulmonary tuberculosis (including fibrosis due to tuberculosis) age less than 40 at index dates
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2
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 40.0-999.0, Chronic Obstructive Pulmonary Disease (COPD) Diagnosis: Chronic obstructive pulmonary disease (COPD) including chronic bronchitis and emphysema, and/or a mixed diagnosis of asthma/COPD Concurrent Conditions or Disease: Subjects with other chronic obstructive lung diseases including but not limited to cystic fibrosis (CF), bronchiectasis, obliterative bronchiolitis, ciliary dyskinesia, post-viral bronchial hyperresponsive syndrome, vocal cord dysfunction, rhinosinusitis, non-eosinophilic asthma, and reactive airways dysfunction syndrome are excluded. In addition, subjects with pneumothorax, fractured rib(s), or signs of cardiac instability including but not limited to a recent myocardial infarction, unstable angina, unstable vital signs, or acute shortness of breath, chest tightness or chest pain are excluded Study Participation Outside of This Protocol: Subjects currently enrolled in studies of Investigational or non-Investigational Drugs or Medical Devices and/or who participated in these studies within 30 days prior to this study are excluded
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2
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 18.0-999.0, Chronic Obstructive Pulmonary Disease HIV seropositivity Age > 18 years Written aggreeing Affiliated or profit of a social coverage Non Age < 18 years old Actual infectious pneumonia COPD exacerbation last 2 months * Recent (less than 1 month) myocardial infarction Thoracic or abdominal pain Enable to answer question secondary to mental deficienty**
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0
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 40.0-75.0, Cerebrovascular Accident Willing to provide the written informed consent More than 6 months onset of unilateral stroke An initial 25-56 or 18-50 scores on the UE subtest of the FMA Sufficient cognitive ability (Mini Mental State Examination ≧ 24 points) Without upper limb fracture within 3 months Recurrent of stroke or seizure episode during the intervention Occurence of serious or continuous pain on affected upper-extremity History of other neurological disease or severe orthopaedic condition
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0
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 40.0-80.0, Percentage of Annual Acute Exacerbation Quality of Life Male or female outpatients aged 40 years≧ 2. Current or ex-smoker, with smoking history 10 pack≧ years 3. COPD (FEV1/FVC < 70%) patients with post-bronchodilator FEV1 70% ≦predicted value, without bronchial reversibility (10% increase post ≦bronchodilator) Diagnosis or suspicion of sleep apnea. 2. Concurrent rhinitis, eczema, and asthma. 3. Clinically overt bronchiectasis, lung cancer, active tuberculosis, or other known specific pulmonary disease. 4. A chest X-ray indicating diagnosis other than COPD that might interfere with the study. 5. Major disease abnormalities are uncontrolled on therapy. 6. Alcohol or medication abuse. 7. Patients had lower respiratory tract infections or received systemic steroid in the 4 weeks prior to the commencement of study. 8. Unable or unwilling to comply with all protocol
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2
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 15.0-50.0, Traumatic Blunt Chest and/or Blunt Abdominal Injury Mechanical ventilator dependence Stable cardiopulmonary function at rest (HR 60-100 beats/min, systolic BP 90-140 mmHg and diastolic BP 60-90 mmHg and SpO2>95%. RR 10-20 breath/min Spine disorders such as spine fracture, HNP, spondylolisthesis, whiplash syndrome, stenosis and spondylosis Fracture of upper and/or lower limbs Underlying acute or chronic cardiopulmonary diseases Craniotomy or craniectomy Unstable intracranial pressure, ICP>12 cmH2O Uncontrolled pain
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0
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 40.0-80.0, Chronic Obstructive Pulmonary Disease (COPD) With Cachexia Written informed consent must be obtained before any assessment is performed Males and females ages 40 to 80 years Smoking history of at least 10 pack-years Diagnosis of COPD according to GOLD guidelines (GOLD, 2010), with a post-bronchodilator FEV¬1 < 80% predicted and FEV1/FVC ratio < 0.70 BMI <20 kg/m2 or skeletal muscle mass index by DXA < 7.25 kg/m2 for men or <5.45 kg/m2 for women In general stable health, including managed COPD, by past medical history, physical examination, vital signs at baseline as determined by the investigator Patients with MRC dyspnoea grade 5 (i.e. patients too breathless to leave the house or breathless when dressing) Plans for lung transplantation or lung reduction surgery within four months of enrollment Patients participating in a formal pulmonary rehabilitation program within 3 months of dosing History of malignancy of any organ system (other than excised non-melanomatous carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases Diseases other than cancer known to cause cachexia or muscle atrophy, including but not limited to congestive heart failure of any stage, chronic kidney disease (estimated GFR < 30 mL/min using the MDRD equation), rheumatoid arthritis, primary myopathy, stroke, HIV infection, tuberculosis or other chronic infection, uncontrolled diabetes mellitus, etc Inflammatory bowel disease, celiac disease, short bowel syndrome, pancreatic insufficiency Use of any prescription drugs known to affect muscle mass, including androgen supplements, anti-androgens (such as LHRH agonists), anti-estrogens (tamoxifen, etc.) recombinant human growth hormone (rhGH), insulin, oral beta agonists, megestrol acetate, dronabinol, metformin, etc Hemoglobin concentration below 11.0 g/dL at screening Liver disease or liver injury Use of other investigational drugs at the time of enrollment, or within 30 days and for any other limitation of participation in an investigational trial based on local regulations
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1
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 18.0-999.0, Multiple Myeloma (Crit.): 1. Has a diagnosis of MM based on the following: Major crit.: 1. plasmacytomas on tissue biopsy 2. bone marrow plasmacytosis (> 30% plasma cells) 3. m-spike on serum electrophoresis IgG > 3.5 g/dL or IgA > 2.0 g/dL; kappa or lambda light chain excretion > 1 g/day on 24 hour urine protein electrophoresis Minor crit.: 1. bone marrow plasmacytosis (10% to 30% plasma cells) 2. monoclonal Ig present but of lesser magnitude than given under major crit. 3. lytic bone lesions 4. normal IgM < 50 mg/dL, IgA < 100 mg/dL, or IgG < 600 mg/dL Any of the following sets of crit. will confirm the diagnosis of MM any 2 of the major crit major criterion 1 plus minor criterion 2, 3, or 4 major criterion 3 plus minor criterion 1 or 3 minor crit. 1, 2, and 3, or 1, 2, and 4 2. MM with measurable disease, defined as a m-spike on serum electrophoresis of at least 0.5 g/dL and/or urine monoclonal protein levels of at least 200 mg/24 hours for patients without measurable serum and urine M-protein levels, an abnormal free light chain ratio (normal value: 0.26 65) 3. Currently has progressive MM Relapsed following stabilization or a response to at least one IV bortezomib (bort.) containing combination regimen that did not contain thalidomide or vincristine or refractory defined as progressed while receiving that anti-myeloma tx POEMS syndrome 2. PCL 3. Primary amyloidosis 4. Diagnosed or treated for another malignancy w/in 3 yrs of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapy. 5. ≤ Grade 2 peripheral neuropathy 6. Pt had myocardial infarction w/in 6 months prior to enrollment or has NYHA Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. 7. Severe hypercalcemia, i.e., serum calcium ≤ 12 mg/dL (3.0 mmol/L) corrected for albumin 8. Undergone major surgery w/in 28 days prior enrollment or has not recovered from side effects of such therapy (see protocol) 9. Received the following prior therapy Thalidomide or vincristine alone or as part of a treatment regimen administered between the last IV bort.-based regimen and Cycle 1, Day 1 on this study. However, prior exposure to thalidomide or vincristine is allowed Chemotherapy w/in 21 days of study drugs (6 weeks for nitrosoureas) Corticosteroids (>10 mg/day prednisone or equivalent) w/in 21 days of study drugs unless steroids are being administered at that dose or greater as part of the new regimen Immunotherapy or antibody therapy as well as lenalidomide, arsenic trioxide or bort. w/in 21 days before study drugs Radiation therapy w/in 21 days before study drugs. (see protocol for exceptions) Use of any other experimental drug or therapy w/in 28 days of study drugs 10. Participation in clinical trials with other investigational agents not included in this trial, w/in 14 days of the start of this trial and throughout the duration of this trial. 11. Hypersensitivity to (bort.), boron, or mannitol. 12. Concurrent use of other anti-cancer agents or treatments 13. Pregnant or lactating patients 14. Serious medical or psychiatric illness 15. Known positivity for HIV or hepatitis B or C
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0
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 20.0-75.0, Chronic Obstructive Pulmonary Disease Age 20-75 For Healthy nonsmoker subjects No current physician diagnosed medical disease requiring active medication No smoking history, defined as less than 100 cigarettes smoked in a lifetime Normal spirometry: FEV1/FVC ≥ 0.70, FEV1 ≥ 80% predicted For Subjects who have participated in the COPDGene Study Post-bronchodilator spirometry: FEV1 > 40% predicted MR contraindications: e.g., electrical implants such as cardiac pacemakers, ferromagnetic implants such as prostheses, claustrophobia Pregnancy or suspected pregnancy Use of continuous oxygen Use of antibiotics and/or systemic corticosteroids (new prescription or increased dose) for an exacerbation of lung disease or any lung infection in the past four weeks Uncontrolled cancer, as defined as ongoing radiation therapy, ongoing chemotherapy A heart attack in the past three months
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1
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 40.0-85.0, Chronic Obstructive Pulmonary Disease (COPD) Subjects who the investigator believes can and will comply with the requirements of the protocol Written informed consent obtained from the subject Male or female subjects between, and including, 40 and 85 years of age, at the time of consent Subjects with confirmed diagnosis of COPD (based on postbronchodilator spirometry). [GOLD, 2009] with FEV1 of >80% (mild COPD) or >50% but ≤80% (moderate COPD) of predicted normal and FEV1/FVC<0.7 Subjects have mild or moderate COPD, according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) staging [GOLD, 2009] Subjects have a current or prior history of ≥10 pack years of cigarette smoking. Former smokers are defined as those who have stopped smoking for at least 6 months. Number of pack years = (number of cigarettes per day/20) x number of years smoked Subjects with recent COPD exacerbations, in stable condition, and having stopped antibiotics, can be enrolled one month post exacerbation Subject also has a confirmed diagnosis of asthma (as only cause of obstructive respiratory disorder), cystic fibrosis, pneumonia risk factors (e.g., HIV, Lupus, Parkinson's, Myasthenia Gravis) or other respiratory disorders (e.g., tuberculosis, lung cancer) Subjects having undergone lung surgery Subject has a α1-antitrypsin deficiency as underlying cause of COPD Subject who experienced a moderate or severe COPD exacerbation not resolved at least 1 month prior to enrolment visit and at least 30 days following the last dose of oral corticosteroids (subjects can be enrolled when their acute or pneumonia has resolved) Subject using any antibacterial, antiviral or respiratory investigational drug or relevant vaccine up to 30 days prior to the enrolment visit Subject has other conditions that the principal investigator judges may interfere with the study findings, such as Subject at risk of noncompliance, or unable to comply with the study procedures Evidence of alcohol or drug abuse Others, as per clinical judgement Women who are pregnant or lactating or are planning on becoming pregnant during the study **If subject has any ONE of the above they cannot be enrolled into the study**
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2
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 40.0-999.0, Pulmonary Disease, Chronic Obstructive Diagnosis of chronic obstructive pulmonary disease 2. Relatively stable airway obstruction with post FEV1=<30% of predicted normal and< 80% predicted normal and post FEV1/FVC <70% 3. Male or female Japanese patients, 40 years of age or older 4. Smoking history of more than 10 pack years Significant disease other than COPD 2. Clinically relevant abnormal lab values 3. History of asthma 4. Diagnosis of thyrotoxicosis 5. Diagnosis of paroxysmal tachycardia 6. A marked baseline prolongation of QT/QTc interval 7. A history of additional risk factors for Torsade de Pointes (TdP) 8. History of myocardial infarction within 1 year of screening visit 9. Unstable or life-threatening cardiac arrhythmia 10. Hospitalization for heart failure within the past year 11. Known active tuberculosis 12. Malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years 13. History of life-threatening pulmonary obstruction 14. History of cystic fibrosis 15. Clinically evident bronchiectasis 16. History of significant alcohol or drug abuse 17. Thoracotomy with pulmonary resection 18. Oral ß-adrenergics 19. Oral corticosteroid medication at unstable doses 20. Regular use of daytime oxygen therapy for more than one hour per day 21. Pulmonary rehabilitation program in the six weeks prior to the screening visit 22. Investigational drug within one month or six half lives (whichever is greater) prior to screening visit 23. Known hypersensitivity to ß-adrenergic drugs, anticholinergics, BAC, EDTA 24. Pregnant or nursing women 25. Women of childbearing potential not using a highly effective method of birth control 26. Patients who have previously been randomized in this study or are currently participating in another study 27. Patients who are unable to comply with pulmonary medication restrictions 28. Patients with narrow-angle glaucoma or micturition disorder due to prostatic hyperplasia etc 29. Patients being treated with medications that prolong the QT/QTc interval
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1
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 40.0-999.0, Chronic Obstructive Pulmonary Disease Patients with stable, symptomatic Chronic Obstructive Pulmonary Disease (COPD) with airflow obstruction of level 2 and 3 according to the current Global initiative for chronic Obstructive Lung Disease (GOLD) strategy (2011). 2. Patients with Forced Expiratory Volume in one second (FEV1) ≥ 30% and <80 % of the predicted normal, and FEV1/ Forced Vital Capacity (FVC) < 0.70 when measured 45 min after the inhalation of 84 µg ipratropium bromide. 3. Current or ex-smokers with at least 10 cigarette pack years smoking history Patients with a history of long QT syndrome, with a prolonged QTc measured during screening, or patients who have a clinically significant ECG abnormality at screening. 2. History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases. 3. Pregnant or nursing (lactating) women. Women of childbearing potential unless using an effective method of contraception. 4. Patients who in the judgment of the investigator, would be at potential risk if enrolled into the study. 5. Patients who have a clinically significant concomitant disease at screening, including but not limited to clinically significant laboratory abnormalities, clinically significant renal, cardiovascular, neurological, endocrine, immunological, psychiatric, gastrointestinal, hepatic, or hematological abnormalities, or with uncontrolled diabetes, which could interfere with the assessment of the efficacy and safety of the study treatment. 6. Patients with a body mass index (BMI) of more than 40 kg/m2. 7. Patients contraindicated for treatment with, or having a history of reactions/ hypersensitivity to anticholinergic agents, long and short acting beta-2 agonists, or sympathomimetic amines. 8. Patients with any history of asthma, with onset of symptoms prior to age 40 years, or patients with a high blood eosinophil count during screening. Other protocol-defined inclusion/
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1
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 18.0-999.0, CHRONIC OBSTRUCTIVE PULMONARY DISEASE ASTHMA HEALTHY SUBJECTS COPD patients, either male or female, over the age of 40 with a clinical diagnosis of COPD with airflow obstruction(FEV1/FVC<0.7) and post-bronchodilator FEV1>50% predicted, gas trapping (on lung volume testing), and decreased carbon monoxide transfer factor. Healthy subjects will be nonsmokers(or exsmokers stopped 5 years ago), will have no respiratory disease, normal spirometry and be age-matched to the COPD patients. Asthmatic subjects, either male or female, over the age of 18 with a clinical diagnosis of Asthma with airflow obstruction (FEV1/FVC<0.7). All patients should be capable of giving informed consent Oral corticosteroids taken within last month. 2. Current involvement (or involvement in the last 4 weeks)in clinical trials assessing investigational medicinal products. 3. Previous adverse reaction to short or long acting β2 agonist. 4. Any subject with a contraindication to taking inhaled beta2-adrenoceptor agonists (especially salbutamol) as listed in the British National Formulary will not be entered into this study. 5. Those who have experienced an acute respiratory exacerbation requiring emergency room treatment and/ or hospitalisation within four weeks of visit 1 (screening visit). 6. Pregnant or breastfeeding women. 7. Subjects unable to give Informed Consent
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1
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 40.0-999.0, Remote Patient Monitoring in COPD Patients Outpatients with a diagnosis of Chronic Obstructive Pulmonary Disease (COPD), GOLD grade 2 or higher as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines, Updated 2011, including Current or ex-smokers with a smoking history of at least 10 pack years nt Post-bronchodilator Forced Expiratory Volume in one second (FEV1) < 80% of the predicted normal value within 12 months prior to screening or at screening Post-bronchodilator FEV1/FVC (Forced Vital Capacity) < 70% within 12 months prior to screening or at screening A documented history of at least 2 COPD exacerbations requiring treatment with systemic corticosteroids and/or antibiotics in the previous 12 months prior to the screening visit, at least one of which required hospitalization Use of investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer Patients who have a COPD exacerbation not clinically resolved within 30 days prior to screening Patients with a history of asthma, indicated by (but not limited to) the onset of respiratory symptoms suggestive of asthma (such as cough, wheezing, shortness of breath) prior to age 40 years
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1
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 40.0-80.0, COPD Men and women Ages 40-80 years Diagnosis of COPD (according to ATS/ERS consensus guidelines) Smoking history ≥ 10 pack years Hospitalization for exacerbation of COPD Pneumonia Pneumothorax Severe comorbidities, such as -Advanced cancer -Pulmonary tuberculosis, which affects more than one third of the total lung parenchyma -Pneumonectomy -Previous diagnosis of left heart failure -Cardiomyopathy with ventricular dysfunction (ejection fraction <45%) -Chronic inflammatory diseases such as asthma, rheumatoid arthritis, pulmonary fibrosis and autoimmune diseases Mechanical Ventilation
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2
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 40.0-999.0, Pulmonary Disease, Chronic Obstructive -Type of subject: Outpatient Informed Consent: A signed and dated written informed consent prior to study participation Age: Subjects 40 years of age or older at Visit 1 Gender: Male or female subjects. A female is eligible to enter and participate if of non-childbearing potential, or if of child bearing potential, has a negative serum pregnancy test at screening, and agrees to one of the acceptable contraceptive methods listed in the protocol, used consistenty and correctly Diagnosis: An established clinical history of COPD in accordance with the definition by the American Thoracic Society/European Respiratory Society Smoking History: Current or former cigarette smokers with a history of cigarette smoking of ≥10 pack-years [number of pack years = (number of cigarettes per day / 20) x number of years smoked (e.g., 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years)]. Former smokers are defined as those who have stopped smoking for at least 6 months prior to Visit 1. Pipe and/or cigar use cannot be used to calculate pack year history Severity of Disease: A pre and post-albuterol/salbutamol FEV1/FVC ratio of <0.70 and a pre and post-albuterol/salbutamol FEV1 of ≤70% of predicted normal values at Visit 1 (Screening) calculated using Nutrition Health and Examination Survey (NHANES) III reference equations Dyspnea: A score of ≥2 on the mMRC Dyspnea Scale at Visit 1 Pregnancy: Women who are pregnant or lactating or are planning on becoming pregnant during the study Asthma: A current diagnosis of asthma Other Respiratory Disorders: Known α-1 antitrypsin deficiency, active lung infections (such as tuberculosis), and lung cancer are absolute exclusionary conditions. A subject who, in the opinion of the investigator, has any other significant respiratory conditions in addition to COPD should be excluded. Examples may clinically significant bronchiectasis, pulmonary hypertension, sarcoidosis, or interstitial lung disease Other Diseases/Abnormalities: Subjects with historical or current evidence of clinically significant cardiovascular, neurological, psychiatric, renal, hepatic, immunological, endocrine (including uncontrolled diabetes or thyroid disease) or hematological abnormalities that are uncontrolled and/or a previous history of cancer in remission for <5 years prior to Visit 1 (localized carcinoma of the skin that has been resected for cure is not exclusionary). Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the subject at risk through participation, or which would affect the efficacy or safety analysis if the disease/condition exacerbated during the study Contraindications: Any history of allergy or hypersensitivity to any anticholinergic/muscarinic receptor antagonist, beta2-agonist, sympathomimetic, corticosteroid (intranasal, inhaled or systemic) lactose/milk protein or magnesium stearate, or a medical condition such as narrow-angle glaucoma, prostatic hypertrophy or bladder neck obstruction that, in the opinion of the study physician contraindicates study participation or use of an inhaled anticholingeric Hospitalization: Hospitalization for COPD or pneumonia within 12 weeks prior to Visit 1 Lung Resection: Subjects with lung volume reduction surgery within the 12 months prior to Visit 1 Lead ECG: An abnormal and significant ECG finding from the 12-lead ECG conducted at Visit 1. Investigators will be provided with ECG reviews conducted by a centralized independent cardiologist to assist in evaluation of subject eligibility. Specific ECG findings that preclude subject are listed in Appendix 4. The study investigator will determine the medical significance of any ECG abnormalities not listed in Appendix 4 Medication Prior to Spirometry: Unable to withhold albuterol/salbutamol for the 4 hour period required prior to spirometry testing at each study visit Medications Prior to Screening: Use of the medications listed in the protocol according to protocol-specific times prio to visit 1
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1
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 40.0-999.0, Pulmonary Disease, Chronic Obstructive Type of subject: Outpatient Informed Consent: A signed and dated written informed consent prior to study participation Age: Subjects 40 years of age or older at Visit 1 Gender: Male or female subjects. A female is eligible to enter and participate if of non-child-bearing potential, or if of child bearing potential, has a megative serum pregnancy test at screening, and agrees to one of the acceptable contraceptive methods listed in the protocol, used consistently and correctly Diagnosis: An established clinical history of COPD in accordance with the definition by the American Thoracic Society/European Respiratory Society Smoking History: Current or former cigarette smokers with a history of cigarette smoking of ≥10 pack-years [number of pack years = (number of cigarettes per day / 20) x number of years smoked (e.g., 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years)]. Former smokers are defined as those who have stopped smoking for at least 6 months prior to Visit 1. Pipe and/or cigar use cannot be used to calculate pack year history Severity of Disease: A pre and post-albuterol/salbutamol FEV1/FVC ratio of <0.70 and a pre and post-albuterol/salbutamol FEV1 of ≤70% of predicted normal values at Visit 1 (Screening) calculated using Nutrition Health and Examination Survey (NHANES) III reference equations Dyspnea: A score of ≥2 on the mMRC Dyspnea Scale at Visit 1 -Pregnancy: Women who are pregnant or lactating or are planning on becoming pregnant during the study Asthma: A current diagnosis of asthma Other Respiratory Disorders: Known α-1 antitrypsin deficiency, active lung infections (such as tuberculosis), and lung cancer are absolute exclusionary conditions. A subject who, in the opinion of the investigator, has any other significant respiratory conditions in addition to COPD should be excluded. Examples may clinically significant bronchiectasis, pulmonary hypertension, sarcoidosis, or interstitial lung disease Other Diseases/Abnormalities: Subjects with historical or current evidence of clinically significant cardiovascular, neurological, psychiatric, renal, hepatic, immunological, endocrine (including uncontrolled diabetes or thyroid disease) or hematological abnormalities that are uncontrolled and/or a previous history of cancer in remission for <5 years prior to Visit 1 (localized carcinoma of the skin that has been resected for cure is not exclusionary). Significant is defined as any disease that,in the opinion of the investigator, would put the safety of the subject at risk through participation, or which would affect the efficacy or safety analysis if the disease/condition exacerbated during the study Contraindications: Any history of allergy or hypersensitivity to any anticholinergic/muscarinic receptor antagonist, beta2-agonist, sympathomimetic, corticosteroid (intranasal, inhaled or systemic) lactose/milk protein or magnesium stearate, or a medical condition such as narrow-angle glaucoma, prostatic hypertrophy or bladder neck obstruction that, in the opinion of the study physician contraindicates study participation or use of an inhaled anticholingeric Hospitalization: Hospitalization for COPD or pneumonia within 12 weeks prior to Visit 1 Lung Resection: Subjects with lung volume reduction surgery within the 12 months prior to Visit 1 Lead ECG: An abnormal and significant ECG finding from the 12-lead ECG conducted at Visit 1. Investigators will be provided with ECG reviews conducted by a centralized independent cardiologist to assist in evaluation of subject eligibility. Specific ECG findings that preclude subject are listed in Appendix 4. The study investigator will determine the medical significance of any ECG abnormalities not listed in Appendix 4 Medication Prior to Spirometry: Unable to withhold albuterol/salbutamol for the 4 hour period required prior to spirometry testing at each study visit Medications Prior to Screening: use of certain medications for the protocol-specific times prior to Visit 1. Oxygen: Use of long-term oxygen therapy (LTOT) described as oxygen therapy prescribed for greater than 12 hours a day. As-needed oxygen use (i.e., ≤12 hours per day) is not exclusionary
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1
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 18.0-999.0, Atrial Fibrillation Tachycardia ICD Therapy Thromboembolic Events Heart Failure Indication for implantation of a single chamber ICD (primary or secondary prevention) according to current guidelines Implanted with a Lumax 540 VR-T DX ICD with Linoxsmart S DX or successor single chamber DX system within 90 days prior to enrollment Written informed consent, willingness and ability to comply with the protocol Age < 18 years Any limitation to contractual capability Female patients who are pregnant or breast feeding or plan a pregnancy during the course of the study Known active malignant disease or recovered from malignant disease within 2 years prior to enrollment Simultaneous participation in another study Life expectancy < 2 years
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0
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 40.0-70.0, COPD Provision of signed written informed consent which includes genetic consent Ability to comply with study procedures Males and females aged 40-70 years inclusive Have a body mass index (BMI) between 18 and 35 kg/m2 inclusive and minimum body weights of 50 kg Have a normal physical examination, and have normal laboratory values, 12-lead ECG and vital signs (blood pressure, heart rate and respiratory rate), unless the Investigator considers an abnormality as not clinically significant Ability to perform reproducible spirometry according to the American Thoracic Society and the European Respiratory Society (ATS/ERS) guidelines (American Thoracic Society, 2005) Ability to produce a minimum 0.1 gram sputum sample after induction with inhaled hypertonic saline. Additional COPD Group A clinical diagnosis of COPD according to the GOLD guidelines (stage 1-2) Current smokers with ≥10 pack-year smoking history Demonstrate a post-bronchodilator ratio between FEV1 and FVC of <70 % and FEV1 ≥50 % of predicted normal. Additional Non-Smokers Group Current evidence or recent history of any clinically significant disease or abnormality (other than COPD in the subjects with COPD group), which in the opinion of the Investigator, would put the subject at risk, or which would compromise the quality of the study data, including but not limited, to cardiovascular disease, myocardial infarction, cardiac failure, uncontrolled hypertension, life-threatening arrhythmias, uncontrolled diabetes, neurologic or neuromuscular disease, liver disease, gastrointestinal disease or electrolyte abnormalities Females with a positive pregnancy test at visit 1 or 3 Females currently breastfeeding Involvement in the planning and conduct of the study Surgery or significant trauma within 3 months of visit 1 History of tuberculosis or other non-specific pulmonary diseases such as asthma Symptoms, signs or laboratory findings suggestive of an ongoing infective illness as judged by the Investigator at visit 1 or 2 Participation in any clinical study with an investigational drug in the 4 months prior to visit 1, or participation in a study with a new formulation of a marketed drug in the 3 months prior to visit 1, or participation in a methodology study in the month prior to visit 1 Symptoms of any clinically significant illness within 2 weeks prior to visit 1 A significant history of alcohol abuse or consumption of more than the recommended units of alcohol per week (28 units for males and 21 units for females)
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1
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 50.0-75.0, Chronic Obstructive Pulmonary Disease Clinical diagnosis of the COPD (Chronic Obstructive Pulmonary Disease) the COPD patients were all in stable condition during recovery from acute exacerbation severe Cardiovascular disease Pneumonia neuromuscular and chest wall deformity Respiratory arrest Cardiovascular instability (hypotension, arrhythmias, myocardial infarction) Change in mental status; uncooperative patient High aspiration risk Viscous or copious secretions Recent facial or gastroesophageal surgery Craniofacial trauma
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1
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 18.0-999.0, Chronic Obstructive Pulmonary Disease (COPD) -Individuals over the age of 18 who have COPD or may be considered to be at increased risk for development of COPD -Individuals under the age of 18
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2
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 40.0-999.0, COPD Aged ≥40 years at initial date of COPD diagnosis COPD diagnosis with Quality Outcome Framework (QoF) approved read code has spirometry data supportive of a COPD diagnosis in the 5 years around initial date diagnosis of COPD (FEV1 % predicted) Patient has one year of data prior to initial date of COPD diagnosis Patient has a minimum of two years of data post initial date of COPD diagnosi Patients whose initial date of COPD diagnosis is before 1997
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2
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 18.0-62.0, Chronic Illness 18 ED visits per year Frequent ED users age 18 to 62 Medicaid insurance only Those living in the greater New Haven area (i.e. having a zip code that matches that) the current visit for primary psychiatric or substance abuse more than 50% of all ED visits in the past year for primary psychiatric or substance abuse
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0
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 40.0-999.0, Pulmonary Disease, Chronic Obstructive Diagnosis of chronic obstructive pulmonary disease 2. Smoking history of more than 10-pack years History of asthma, allergic rhinitis, myocardial infarction or unstable of life-threatening cardiac arrhythmias 2. Marked baseline prolongation of QT/QTc interval
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2
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 18.0-65.0, Obese BMI limited in the range of 30 kg/ m2 to 50 kg/ m2, 18-65 years of age ASA physical status classification I-III Requiring general anesthesia for elective surgery - Patients with major cardiovascular disease, respiratory disease, cerebral vascular disease or American Society of Anesthesiologists physical status class IV or greater. 2. Abnormal vital signs on the day of admission for surgery [heart rate (HR, >100 bpm or < 40 bpm), blood pressure (BP, >180/100 mmHg or < 90/60 mmHg), room air transcutaneous oxyhemoglobin saturation (SPO2) < 96%] that are not correctable with his or her routine medication or commonly used pre-operative medication. 3. Having claustrophobia and not able to tolerate the mask. 4. Any person with an anticipated difficult airway or those with a history of difficult airway who requires a fiberoptic intubation while awake. 5. Gastric-esophageal reflex disease that is refractory to treatment or a full stomach. 6. The subject has been in bed for more than 24 hours. 7. Neurological symptoms associated with neck extension, a neurological deficit from a previous stroke or spinal cord injury, a recent stroke or transient ischemic attack (TIA) within 2 weeks. 8. Pregnant women and women less than one month post-partum. Ruling out pregnancy will be conducted by careful history and physical examination as performed routinely prior to surgery. If the history is believed to be unreliable, the patient will be excluded unless a pregnancy test is performed and the result of the test is negative. 9. Emergency cases and subjects who have not adhered to the ASA NPO (Nil Per Os) guidelines. -
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0
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 40.0-999.0, Emphysema Subject has severe and heterogeneous emphysema with severe dyspnea Subject certified to meet the of ATS/ERS guidelines for management of stable COPD Subject must be able to demonstrate physical ability to participate in the study by performing a 6-minute walk distance of ≥ 140 m Subject has abstained from cigarette smoking for 4 months and is willing to abstain throughout the study Pulmonary Function Testing Results (PFT's) demonstrate FEV1 ≤ 45% of predicted RV ≥ 150% of predicted TLC ≥ 100% of predicted Patient has a BMI < 15 kg/m2 Arterial Blood Gas Level (ABG) indicates PCO2 > 55 mm Hg PO2 < 45 mm Hg on room air Subject has a diffuse emphysema pattern Subject has bronchitis with sputum production > 4 Tablespoons or 60 ml per day Subject has an active asthma (>15 mg of prednisone daily) Giant bulla (> 1/3 volume of lung) Pulmonary hypertension Subject with prior major lung surgery or recent hospitalization for COPD exacerbation or respiratory infections
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1
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 0.0-999.0, COPD - Chronic Obstructive Pulmonary Disease Muscle Atrophy Have a primary diagnosis of COPD Be admitted to the pulmonary ward due to an exacerbation in COPD Provide informed consent to participation in the study Be able to maintain an upright position on a chair Be able to be guided to training and understand instructions for participating Patients suffering from diseases that prevents the use of wrist weights such as Deep venous thrombosis (DVT) Erysipelas Painfull edema of the limbs And Lack of ability to walk, habitually Already participating in COPD rehabilitation program Predicted hospital stay of less than tree days as predicted by a • pulmonary physician Patients admitted Friday night or Saturday morning cannot be stared up within 24 hours of admittance
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2
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 18.0-50.0, Asthma Healthy Volunteers Be a man or woman between 18 to 50 years of age, inclusive, at the time of signing the informed consent Sign an informed consent document indicating they understand the purpose of and procedures required for the study and are willing to participate in the study If a woman of childbearing potential, must have a documented menstrual period prior to the first dose and be willing and able to use two forms of contraception from screening to 90 days after the final dose of RV1729, OR If a woman of non-childbearing potential must be amenorrhoeic for greater than 1 year or have been permanently sterilised, OR If a man, must be willing and able to use one of the contraception methods listed in the protocol and agree not to donate sperm, the first dose until 90 days after they receive the final dose of RV1729 Body mass index between 19 and 30 kg/m2 (inclusive), and body weight not less than 50 kg Vital sign assessments within normal ranges: blood pressure between 90 and 140 mmHg systolic, inclusive, and between 40 and 90 mmHg diastolic; heart rate 40 bpm Have a 12-lead ECG consistent with normal cardiac conduction and function Capable of complying with all study restrictions and procedures including ability to use the study Dry Powder Inhaler correctly Parts A & B (healthy volunteers only) Upper or lower respiratory tract infection within 4 weeks of the screening visit Clinically significant abnormal values for haematology, clinical chemistry or urinalysis at screening History of, or a reason to believe a subject has a history of drug or alcohol abuse within the past 5 years Positive test for alcohol or drugs of abuse at screening or prior to dosing History of clinically significant allergies that would contraindicate participation Known allergy to the study drug or any of the excipients of the formulation Donated blood or blood products or had substantial loss of blood (more than 500 mL) within 3 months before the study Received an experimental drug or used an experimental medical device within 3 months or within a period less than 10 times the drug's half life before the first dose of the study drug is scheduled If a woman, has a positive serum pregnancy test at screening or on admission, is pregnant, breast-feeding or planning to become pregnant during the study Positive test for human immunodeficiency virus (HIV) 1 and 2 antibodies, hepatitis B virus (HBV) infection, or hepatitis C antibodies
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1
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 18.0-999.0, COPD Severe or Very Severe Airflow Obstruction and/or Receiving or Eligible to Receive Long-term Oxygen Therapy Idiopathic Pulmonary Fibrosis Other Interstitial Lung Disease Without Curative Therapy Congestive Heart Failure NYHA Class IV or NYHA Class III Plus 1 Hospitalization in the Past Year Malignancy Any Stage 3B or 4 Solid Tumor Age > 18 years Chronic Obstructive Pulmonary Disease (COPD) with severe or very severe airflow obstruction on pulmonary function testing and or receiving or eligible to receive long-term oxygen therapy AND/OR Idiopathic Pulmonary Fibrosis (IPF) AND/OR Other interstitial lung disease without curative therapy AND/OR Any stage 3B or 4 solid tumor AND/OR Congestive Heart Failure (CHF) either New York Heart Association NYHA) class IV or NYHA class III plus 1 hospitalization in the past year No previously signed advance directive in the medical record Neither listed for nor considering lung or heart transplantation High anticipated risk for critical illness in the next 2 years based on clinical judgment Interest in thinking about filling out an Advance Directive Diseases for which life-extending medical therapies may be available Inability to speak and/or read English proficiently New clinic patients meeting the clinic provider for the first time Patients being actively evaluated or already listed for transplants Patients already having an AD Cognitive impairment necessitating proxy consent
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2
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 18.0-999.0, Chronic Obstructive Pulmonary Disease COPD diagnosis with exacerbation No contraindication of physiotherapy Signed written consent Medical approval for inclusion Heart disease Neurological patients Contraindications of physiotherapy
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2
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 21.0-90.0, Chronic Obstructive Pulmonary Disease patients with COPD meeting the Global Initiative for Obstructive Lung Disease (GOLD) guidelines, with forced expiratory volume in the first second of expiration (FEV1) <80% predicted, FEV1/FVC ratio <70% predicted (FVC= forced vital capacity), and total lung capacity (TLC) >80% predicted), with or without sputum, will be included. The severity of COPD will be classified according to GOLD Stage I: mild FEV1/FVC<0.70 and FEV1>80% predicted; Stage II: moderate FEV1/FVC<0.70 and 50<FEV1<80% predicted; Stage III: severe FEV1/FVC<0.70 and 30<FEV1<50% predicted; Stage IV: very severe FEV1/FVC<0.70 and FEV1<30% or FEV1<50% predicted plus chronic respiratory failure Patients with Upper respiratory tract infection within the previous 28 days Treatment with antibiotics within 4 weeks prior the study Acute dyspnoea or hemoptysis Chest pain or recent history of rib fracture or pneumothorax Acute cardiovascular events in the previous 3 months Any history or evidence of renal, gastrointestinal or hepatic disease Any history and evidence of neuropsychiatric disease Alcohol, drug abuse or any other condition associated with poor compliance Breast feeding
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1
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 18.0-65.0, Asthma Asthma: A doctor diagnosis of asthma Age of subject: 18 to 65 years of age inclusive, at the time of signing the informed consent Severity of Disease: A screening pre-bronchodilator FEV1 >=60% of predicted Reversibility of Disease: Demonstrated presence of reversible airway disease at screening Current Therapy: On inhaled corticosteroid (ICS) with or without a SABA for at least 12 weeks prior to screening. Able to stop current Short-Acting Beta2-Agonists (SABA) and replace with albuterol/salbutamol inhaler Body weight and BMI: Body weight >=50 kilogram (kg) and Body Mass Index (BMI) within the range 19.0 to 29.9 kilogram per square meter (kg/m^2) (inclusive) Gender: Male or female. A female subject is eligible to participate if she is of: Non-childbearing potential. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment. Child-bearing potential and agrees to use one of the contraception methods for an appropriate period of time (as determined by the product label or investigator) prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point. Female subjects must agree to use contraception until completion of the follow-up visit Liver Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) <2x Upper limit of normal (ULN); alkaline phosphatase and bilirubin <=1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%) Consent: Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form A history of life-threatening asthma Other significant pulmonary diseases: pneumonia, pneumothorax, atelectasis, pulmonary fibrotic disease, bronchopulmonary dysplasia, chronic bronchitis, emphysema, chronic obstructive pulmonary disease, or other respiratory abnormalities other than asthma Respiratory Infection: 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 screening that; 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 Asthma Exacerbation: Any asthma exacerbation requiring oral corticosteroids within 12 weeks of screening or that resulted in overnight hospitalization requiring additional treatment for asthma within 6 months prior to screening Concomitant Medications: Use of the medications, ICS were prohibited for each study period from 24 hours prior to dosing to 72 hours after dosing; Long acting beta agonist (LABA), leukotriene receptor antagonist (LTRA) or long acting muscarinic anatagonist (LAMA) were prohibited for 12 weeks prior to screening; High doses of an ICS were prohibited for 8 weeks prior to screening; Oral steroids were prohibited for 12 weeks prior to screening; Potent CYPP3A4 inhibitors were prohibited within 4 weeks prior to dosing. The following medications may not be used during the study from first dosing to the end of period 2 inclusive: Anticonvulsants, Polycyclic antidepressants, β-adrenergic blocking agents, Phenothiazines and Monoamine oxidase (MAO) inhibitors Other concurrent Diseases/Abnormalities: A subject has any clinically significant, uncontrolled condition or disease state that, in the opinion of the investigator, would put the safety of the subject at risk through study participation or would confound the interpretation of the study results if the condition/disease exacerbated during the study Oropharyngeal examination: A subject will not be eligible if he/she has clinical visual evidence of oral candidiasis at screening Pregnancy and Lactating Females:Pregnant females as determined by positive serum human chorionic gonadotropin (hCG) test at screening or by positive urine hCG test prior to dosing. Lactating females Allergies: Milk Protein Allergy: History of severe milk protein allergy. Drug Allergy: Any adverse reaction including immediate or delayed hypersensitivity to any beta2-agonist, sympathomimetic drug, or any intranasal, inhaled, or systemic corticosteroid therapy. Known or suspected sensitivity to the constituents of the dry powder inhaler (DPI) (i.e., lactose or magnesium stearate). Historical Allergy: History of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation Lead ECG abnormality: Significant abnormality in the 12-lead electrocardiogram (ECG) performed at screening
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0
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 40.0-999.0, Pulmonary Disease, Chronic Obstructive Men and women aged 40 years or over History of current or former smoking of at least 10 pack-years Cooperative outpatients, with a COPD diagnosis established by the measurement of FEV1/FVC < 0.7 post-bronchodilation in basal spirometry (without use of medication or post-washout). Moderate to severe stage patients will be included, with post-bronchodilator FEV1 between 30 and 80% of the normal value according to GOLD 2011 since the in this trial will be based on spirometry results Pregnant women or nursing mothers History of asthma at visit 1 indicated by, but not limited to Onset of respiratory symptoms suggestive of asthma (such as coughing, wheezing, shortness of breath) before the age of 40 History of diagnosed asthma History of respiratory tract infection within six weeks prior to Visit 1 History of hospitalization or emergency care for a COPD exacerbation in the 3 months prior to Visit 1 Subjects who require use of home oxygen therapy
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1
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 0.0-999.0, Fever COPD Obesity Congenital Heart Disease Respiratory Distress Adults with controlled and non-controlled hypertension (hypertension defined as > 130/90 on two separate occasions and history of hypertension) Adults with known chronic obstructive pulmonary disease in respiratory distress with oxygen saturations < 90% Febrile adults (temp at triage > 38 C) with no significant co-morbidities Elderly (>70 years) patients with no significant co-morbidities Obese adults (BMI > 30) Febrile (temp at triage > 38 C) and non-febrile children (age < 18 yrs) Obese children (BMI > 30) Neonates (age < 6 weeks) Children with corrected cyanotic congenital heart disease Children in respiratory distress that present with oxygen saturations < 90% -Subjects with unstable vital signs will be excluded
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2
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 35.0-75.0, Pulmonary Emphysema HRCT-confirmed diagnosis of lung emphysema by two independent radiologists post-bronchodilator FEV1/FVC ratio < 0.7 post-bronchodilator FEV1 % predicted value ≥ 20% and < 50% age 35 and 75 years of, of either sex, and of any race current or ex-smoker, with a cigarette smoking history ≥ 10 pack-years • asthma or other clinically relevant lung disease other than COPD (e.g. restrictive lung diseases, sarcoidosis, tuberculosis, idiopathic pulmonary fibrosis, or lung cancer) α1-Antitrypsin deficiency Presence of bullae (more than 10 cm in the diameter) active infection within 4 weeks of screening significant exacerbation of COPD or has required mechanical ventilation within 4 weeks of screening clinically relevant uncontrolled medical condition not associated with COPD documented history of uncontrolled heart failure pulmonary hypertension due to left heart condition Subject has evidence of active malignancy, or prior history of active malignancy Subject has a life expectancy of < 6 months
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1
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 18.0-80.0, Snoring every night snoring; 2. no medication known to influence nasal resistance (e.g., antihistamines, vasoconstrictors, topical or systemic steroids); 3. no smoking for the last 6 months; 4. no upper or lower respiratory tract disease (e.g., upper respiratory tract infection, rhinitis, sinusitis, chronic obstructive pulmonary disease), including a history of nasal allergy; and 5. written informed consent from each patient duration of snoring less than 60 minutes during sleep study, and 2. central apnoeas more than five percent of total apnoeas
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0
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 40.0-999.0, Chronic Obstructive Pulmonary Disease Dyspnea Male or Female Aged ≥40 years Ambulatory Cigarette smoking history ≥15 pack years No change in medication dosage or frequency of administration, with no exacerbations or hospitalization in the preceding 6 weeks Post-bronchodilator Forced Expiratory Volume in 1 second between 30-80% predicted Post-bronchodilator Forced Expiratory Volume in 1 second/forced vital capacity ratio of <70% Presence of active cardiopulmonary disease other than COPD Use of domiciliary oxygen Exercise-induced arterial blood oxyhemoglobin desaturation to <80% on room air Body Mass Index <18.5 or ≥35 kg/m2 Allergy to latex Allergy to lidocaine or its "caine" derivates
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1
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 45.0-90.0, Chronic Obstructive Pulmonary Disease (COPD) Signature of informed consent COPD patients with age raging from 50 to 85 years old Patients with at least a history of COPD of one year COPD patients clinically stable in the last three months COPD subjects with FEV1 (Forced Expiratory Volume in 1st second)<70% of predicted value FEV1/FVC (Forced Expiratory Volume in 1st second/Forced Vital Capacity) <88% (males) or <89% (females) of LLN (Low Levels of Normality) COPD former or active smokers with at least a smoking history of 20 pack year Acute Bronchial Exacerbation at recruitment Fertile women with age between 18 and 50 years old or with active period Pregnancy Subjects enrolled in other clinical trials or that have taken part in one of them in the month preceding the enrollment FEV1/FVC more than 70% of predicted value in basal conditions FEV1 more than 70% of predicted value in basal conditions Known deficit of alpha 1 antitrypsin Subjects that underwent a Lung Volume Reduction Surgery (LVRS) Subjects with known positivity to Human Immunodeficiency Virus (HIV) Misuse of alcool or drugs
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1
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 40.0-999.0, Pulmonary Disease, Chronic Obstructive Patients Admitted in Emergency Department for Acute Exacerbation patients > 40 years old Acute exacerbation of COPD Medico social conditions not allowing home discharge Other causes of Dyspnea: Pneumothorax, pulmonary embolism, pulmonary oedema, lung cancer Pneumonia on chest ray acute respiratory distress requiring immediate ICU transfer
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2
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 40.0-90.0, Chronic Obstructive Pulmonary Disease Patients with moderate or severe COPD exacerbation who are older than 40-years-old A smoking history of at least 10-pack-years Requiring hospitalization because of COPD exacerbation Presence of asthma, allergic rhinitis, atopy or any systemic disease (such as diabetes mellitus or hypertension) Exposed to systemic corticosteroids in the preceding month or used more than 1,500 microg/d of inhaled beclomethasone equivalent Admission to the intensive care unit (pH<7.30 and/or PaCO2 > 70 mm Hg, and/or PaO2 < 50 mm Hg despite supplemental oxygen) If a specific cause for the exacerbation, such as pneumonia, pneumothorax, or heart failure, was diagnosed
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2
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 40.0-999.0, Pulmonary Disease, Chronic Obstructive Informed consent Subject must give their signed and dated written informed consent to participate Subject understands and is willing, able, and likely to comply with study procedures and restrictions Subject must be able to read, comprehend, and record information in English Age: >=40 years of age at Visit 1 Gender: Male or female subjects COPD diagnosis subjects with a clinical history of COPD in accordance with the definition by the American Thoracic Society/European Respiratory Society Severity of disease Subject with a measured post-albuterol Forced expiratory volume in 1 second (FEV1)/ Forced vital capacity (FVC) ratio of <=0.70 at Visit 1 Subjects with a measured post-albuterol FEV1 <=70% of predicted normal values calculated using Third National Health and Nutrition Examination Survey reference equations at Visit 1 Previous experience with the inhaler Subjects who used any inhaler (e.g., participated in a clinical study of fluticasone propionate/salmeterol, or any component of them, or placebo) within 6 months (i.e., 180 days) prior to Visit 1 Previous experience with the inhaler Subjects who used any inhaler (e.g., participated in a clinical study of FF/VI or GSK573719/GW642444 [umeclidinium/vilanterol], or any component of them, or placebo) within 6 months (i.e., 180 days) prior to Visit 1 Asthma: Subjects with a current diagnosis of asthma Subjects with a prior history of asthma are eligible if they have a current diagnosis of COPD Poorly controlled COPD: Subjects with symptoms of poorly controlled COPD such as Acute worsening of COPD that is managed by the subject with corticosteroids or antibiotics or that requires treatment prescribed by a physician, in the 4 weeks prior to Visit 1 Hospitalization due to acute worsening of COPD within 4 weeks of Visit 1 Use of a total of 8 puffs/day or more of short-acting symptom relief medications such as albuterol and ipratropium for 2 consecutive days or any 3 days within 7 days immediately preceding Visit 1
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1
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 50.0-999.0, Benign Prostatic Hyperplasia Males age of 50 years or older diagnosed with symptomatic benign prostatic hyperplasia (BPH) Size, volume,length of prostate
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0
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 40.0-90.0, COPD volunteers with COPD for Patients Group volunteers without any respiratory disease for the control group individuals with history of tuberculosis or other lung disease heart disease in general and disability in the exams
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2
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 0.083-19.0, Sepsis Critical Illness Children age 1 month-19 years 2. Diagnosis of severe sepsis diagnosed as clinical sepsis syndrome (requires two of the following criteria) Source of infection Fever or Hypothermia Leukocytosis or Leucopenia Poor organ perfusion (such as delayed capillary refill or decreased urine output or hypotension) Bacteremic sepsis demonstrated by positive blood culture 3. Weight greater or equal to 4.0 kg 4. Need for enteral nutrition by a nasogastric/nasoduodenal tube 5. Presence of central and/or arterial venous access as per clinical indication Patients with metabolic diseases (i.e. Insulin dependent diabetes mellitus, urea cycle disorders, cystinuria, etc.) 2. Pregnancy 3. Primary liver failure 4. Primary renal failure 5. Patients unable to tolerate enteral feedings 6. Weight less than 4.0 kg
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0
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 18.0-65.0, Irritable Bowel Syndrome Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Abdominal Pain Meet Rome III for IBS. 2. Willing and able to provide written informed consent. 3. If a female of childbearing potential, must be using an acceptable form of contraception during the study and for 30 days after the last dose. Acceptable methods surgical sterilization, hormonal contraceptives (such as oral contraceptives, Depo-Provera, NuvaRing), condoms used with a spermicide, an IUD [Intrauterine device] or abstinence. Females are not considered to be of childbearing potential if they are postmenopausal for at least 2 years or have been surgically sterilized. 4. Aged 18 to 65 years, inclusive. 5. Have a body mass index (BMI) between 18 and 40 kg/m2, inclusive. 6. Have a negative urine drug screening at Visit 1. 7. Have normal or not clinically significant laboratory results as reviewed by the study physicians. 8. Have a normal rectal examination result on file within the past 2 years or performed at Visit 1 in order to the possibility of an evacuation disorder (examination must findings suggestive of an evacuation disorder such as high sphincter tone at rest, failure of perineal descent and spasm, tenderness or paradoxical contraction of the puborectalis muscles). 9. Agree to avoid alcohol during the entire study to avoid corrupting the data from the rectal barostat tests Have a structural or metabolic diseases or conditions that affect the GI system. 2. Be taking any medication that in the opinion of the principal investigator has a potential to alter GI transit (this includes but is not limited to osmotic or stimulant laxatives, magnesium or aluminum-containing antacids, prokinetics, erythromycin, gabapentin, pregabalin, narcotics, anticholinergics, antidepressants [including selective norepinephrine reuptake inhibitors], antipsychotics, opiates, GABAergic agents and benzodiazepines). Note: Tricyclic antidepressants are permissible at doses equal to or less than 25 mg daily; selective serotonin reuptake inhibitor antidepressants are permissible at low, stable doses. Analgesics such as Tylenol, ibuprofen, naproxen and aspirin are not permissible during Visits 2 and 3 to avoid corrupting data from the rectal barostat tests. All medications will be reviewed by the principal investigator on a case by case basis. Rescue medications: Rescue medications will be reviewed and approved as necessary for exacerbation of constipation or diarrhea since the study medication treatment period is about 14 days total. The patient will contact the study staff to request review and approval of the use of a rescue medication by the principal investigator. The use of the rescue medication will be documented by the patient in the bowel pattern, bloating and pain diary. Rescue medications are not allowed within 7 days of the rectal sensation studies to ensure data integrity. 3. Have clinical evidence, including but not limited to, of a clinically significant abnormal physical examination or laboratory value or of a past event documented in the past medical record, or current clinically significant abnormal physical examination or laboratory value that could indicate significant cardiovascular, respiratory, renal, hepatic, GI, hematological, neurological, psychiatric or other diseases that interfere with the objectives of the study. If a laboratory test value falls outside of the reference range and is considered clinically significant, it may be repeated once at the discretion of the principal investigator. If the laboratory test result remains abnormal and clinically significant, the patient will be discontinued from the study and referred to a primary care physician for evaluation. 4. Be a known substance abuser or be considered to be an alcoholic not in remission. 5. Have participated in another clinical study in the past 30 days. 6. Have a history of allergic reactions to egg, ginseng, ginger or Sichuan pepper. 7. Be clinically lactose intolerant
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0
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 0.083-19.0, Sepsis Critical Illness Age 1 month-19 years 2. Diagnosis of severe sepsis diagnosed as clinical sepsis syndrome (requires two of the following criteria) Source of infection Fever or Hypothermia Leukocytosis or Leucopenia Poor organ perfusion (such as delayed capillary refill or decreased urine output or hypotension) Bacteremic sepsis demonstrated by positive blood culture 3. Weight greater or equal to 4 kg 4. Need for parenteral nutrition 5. Presence of central and/or arterial venous access as per clinical indication Patients with metabolic diseases (i.e. Insulin dependent diabetes mellitus, urea cycle disorders, cystinuria, etc.) 2. Pregnancy 3. Primary liver failure 4. Primary renal failure 5. Patients on enteral feedings greater than 20% of daily requirement 6. Weight less than 4.0 kg
|
0
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 18.0-999.0, Chronic Obstructive Pulmonary Disease (COPD) patients with diagnosed COPD via the medical records with code J44 terminal illness cognitive impairments
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2
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 40.0-999.0, Pulmonary Disease, Chronic Obstructive Type of subject: Outpatient Informed Consent: A signed and dated written informed consent prior to study participation Age: Subjects 40 years of age or older at Visit 1 Gender: Male or female subjects. A female is eligible to enter and participate in the study if she is of: Non-child bearing potential (i.e. physiologically incapable of becoming pregnant, including any female who is post-menopausal or surgically sterile). Surgically sterile females are defined as those with a documented hysterectomy and/or bilateral oophorectomy or tubal ligation. Post-menopausal females are defined as being amenorrhoeic for greater than 1 year with an appropriate clinical profile, e.g. age appropriate, >45 years, in the absence of hormone replacement therapy. OR Child bearing potential, has a negative pregnancy test at screening, and agrees to one of the following acceptable contraceptive methods used consistently and correctly (i.e. in accordance with the approved product label and the instructions of the physician for the duration of the study screening to follow-up contact) Abstinence Oral Contraceptive, either combined or progestogen alone Injectable progestogen Implants of levonorgestrel Estrogenic vaginal ring Pregnancy: Women who are pregnant or lactating or are planning on becoming pregnant during the study Asthma: A current diagnosis of asthma Other Respiratory Disorders: Known α-1 antitrypsin deficiency, active lung infections (such as tuberculosis), and lung cancer are absolute exclusionary conditions. A subject who, in the opinion of the investigator, has any other significant respiratory conditions in addition to COPD should be excluded. Examples may clinically significant bronchiectasis, pulmonary hypertension, sarcoidosis, or interstitial lung disease. Allergic rhinitis is not exclusionary Other Diseases/Abnormalities: Subjects with historical or current evidence of clinically significant cardiovascular, neurological, psychiatric, renal, hepatic, immunological, endocrine (including uncontrolled diabetes or thyroid disease) or hematological abnormalities that are uncontrolled and/or a previous history of cancer in remission for <5 years prior to Visit 1 (localized carcinoma of the skin that has been resected for cure is not exclusionary). Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the subject at risk through participation, or which would affect the efficacy or safety analysis if the disease/condition exacerbated during the study Exacerbations: Has had more than 1 moderate or severe COPD exacerbation in the past 12 months. Subjects with a moderate exacerbation within 6 weeks or severe exacerbations within 10 weeks prior to Visit 1 are excluded from study. A moderate COPD exacerbation is defined as worsening symptoms of COPD that require treatment with oral/systemic corticosteroids and/or antibiotics. A severe exacerbation is defined as worsening symptoms of COPD that require in-patient hospitalization Contraindications: A history of allergy or hypersensitivity to any anticholinergic/muscarinic receptor antagonist, beta2-agonist, lactose/milk protein or magnesium stearate or a medical condition such as narrow-angle glaucoma, prostatic hypertrophy or bladder neck obstruction that, in the opinion of the study physician contraindicates study participation or use of an inhaled anticholinergic Lung Resection: Subjects with lung volume reduction surgery within the 12 months prior to Screening (Visit 1) Lead ECG: An abnormal and significant ECG finding from the 12-lead ECG conducted at Visit 1, including the presence of a paced rhythm on a 12-lead ECG which causes the underlying rhythm and ECG to be obscured. Investigators will be provided with ECG reviews conducted by a centralized independent cardiologist to assist in evaluation of subject eligibility. Specific ECG findings that preclude subject are listed in Appendix 3. The study investigator will determine the medical significance of any ECG abnormalities not listed in Appendix 3. Appendix 3 Sinus tachycardia ≥120 bpm. *Note: sinus tachycardia ≥120bpm should be confirmed by two additional readings at least 5 minutes apart Sinus bradycardia <45bpm. *Note: Sinus bradycardia <45bpm should be confirmed by two additional readings at least 5 minutes apart
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1
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 18.0-999.0, Chronic Illness years or older Having one or more of 21 chronic conditions, including those with depression and multiple chronic comorbidities Presence of Major Cancer, HIV, or ESRD in either the baseline or measurement periods Claims in excess of $100,000 in either baseline or intervention period Claims for long term care or hospice in either baseline or intervention period
|
0
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 40.0-999.0, Chronic Obstructive Pulmonary Disease Male or female adults aged ≥ 40 years with a diagnosis of COPD Current smokers or ex-smokers A post-bronchodilator FEV1 < 50% of the predicted normal value and a post- bronchodilator FEV1/FVC < 0.7 At least one exacerbation in the 12 months preceding the screening visit Pregnant or lactating women Diagnosis of asthma or history of allergic rhinitis or atopy Patients treated with non-cardioselective β-blockers in the month preceding the screening visit Patients treated for exacerbations in the 4 weeks prior to screening visit Patients treated with long-acting antihistamines unless taken at stable regimen at least 2 months prior to screening and to be maintained constant during the study or if taken as PRN Patients requiring long term (at least 12 hours daily) oxygen therapy for chronic hypoxemia Known respiratory disorders other than COPD Patients who have clinically significant cardiovascular condition
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1
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 18.0-999.0, COPD Exacerbation Severe exacerbation episode of COPD, requiring hospital admission
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2
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