A Study for Disease Profiling of Asthma and Chronic Obstructive Pulmonary Disease

A Multicenter Longitudinal Study for Disease Profiling of Asthma and Chronic Obstructive Pulmonary Disease

The purpose of this study is to characterize the clinical, physiologic, and molecular profiles of healthy participants, participants with mild, moderate, and severe asthma; and participants with moderate to severe Chronic Obstructive Pulmonary Disease (COPD).

This is a multi-center, longitudinal (participants are followed over long period of time with continuous or repeated observations of health outcomes) exploratory study (biomarkers, clinical and physiological parameters for participants with asthma and COPD are observed for the first time). This study will be conducted in 2 parts. Part 1 will include healthy participants and participants with mild, moderate, and severe asthma. Part 2 will include healthy nonsmokers, healthy asymptomatic smokers, and participants with moderate and or severe COPD. Study participants will undergo medical tests that will include pulmonary function testing, assessment of airway reactivity, bronchoscopy procedure, blood samples for routine laboratory tests, biomarkers and DNA evaluation (for some study participants), induced sputum collection, and exhaled nitric oxide collection. Safety evaluations will includes assessment of adverse events, clinical laboratory tests, 12-lead electrocardiogram, vital signs, and physical examinations.

Inclusion Criteria:

• Age: for Part 1, healthy: 18 and 55 years; for Part 1, asthma: 18 and 70 years; for Part 2, nonsmokers: 40 and 65 years; for Part 2, smokers: 40 and 65 years; for Part 2, chronic obstructive pulmonary disease (COPD): 40 and 65 years
• Having mild, moderate, or severe asthma (for Part 1, asthma)
• Clinically stable asthma and have been on their current asthma controller therapy for at least 6 weeks prior to screening (for Part 1, asthma)
• No history of chronic respiratory disease including asthma (for Part 2, nonsmokers)
• Be a nonsmoker for 1 year or more at initial screening visit and have 10 packs or less per year history of smoking (for all Part 1 and Pat 2, nonsmokers)
• Be a current smoker with a current history of at least 20 pack years (for Part 2, smokers)
• Stable COPD in the 3 months prior to screening (for Part 2, COPD)
• Treating with Beta-adrenergic receptor agonist, anticholinergic bronchodilators, inhaled corticosteroid at stable doses for at least 4 weeks prior to screening (for Part 2, COPD)

Exclusion Criteria:

• History of sleep apnea requiring medical intervention and positive urine pregnancy screening result (for all Part 1 and Part 2)
• Positive urine screen for nicotine; positive serology test for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen, or hepatitis C virus antibody at screening (for all Part 1 and Part 2)
• Allergic bronchopulmonary aspergillosis, allergic bronchopulmonary mycosis, or occupational asthma (for Part 1, asthma)
• Requires long term oxygen therapy on a daily basis for chronic hypoxemia at screening visit except when used for exercise only (for Part 2, COPD)
• Pneumonia, COPD exacerbation that required systemic steroids, upper or lower respiratory tract infection, lung cancer surgery, lung volume reduction, or a lung transplant (for Part 2, COPD)