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

Completed · Early Phase 1

Conditions studied: Asthma, Pulmonary Disease, Chronic Obstructive

In brief

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).

Key facts

Study ID

NCT01274507

Run by

Janssen Research & Development, LLC

People needed

328

Starts

2010-07-01

Expected to finish

2014-07-01

Last updated by the study team

2016-12-20

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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)

Where it is running

• Study site — Birmingham, Alabama, United States
• Study site — New Haven, Connecticut, United States
• Study site — Chicago, Illinois, United States
• Study site — Iowa City, Iowa, United States
• Study site — Baltimore, Maryland, United States
• Study site — Chapel Hill, North Carolina, United States
• Study site — Cleveland, Ohio, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Galveston, Texas, United States
• Study site — Calgary, Alberta, Canada
• Study site — Vancouver, British Columbia, Canada
• Study site — Montreal, Quebec, Canada
• Study site — Sainte-Foy, Quebec, Canada
• Study site — København NV, Denmark
• Study site — Bordeaux Pessac N/A, France
• Study site — Marseille, France
• Study site — Frankfurt, Germany
• Study site — Lübeck, Germany
• Study site — Rotterdam, Netherlands
• Study site — Bucharest, Romania
• Study site — Manchester, United Kingdom

Full record on ClinicalTrials.gov

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