A Study of the Inflammatory Pathways Associated With Chronic Obstructive Pulmonary Disease Exacerbations
Completed
- Conditions
- Chronic Obstructive Pulmonary Disease
- Registration Number
- NCT01337661
- Lead Sponsor
- MedImmune LLC
- Brief Summary
The purpose of this study is to observe how the inflammatory pathways differ in subjects with chronic obstructive pulmonary disease (COPD) during an acute exacerbation of COPD (AECOPD).
- Detailed Description
This is an observational study in adult male and female subjects with COPD to collect blood, endobronchial tissues and BAL to investigate the inflammatory genes/pathways associated with AECOPD at the time of exacerbation (ie, active disease) and at 6 weeks later (ie, stable disease).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 26
Inclusion Criteria
- Physician-diagnosed acute exacerbations of chronic obstructive pulmonary disease
- Current or ex-smoker with a tobacco history of 15 or more pack years
- Females of childbearing potential must use birth control for the duration of the study.
Exclusion Criteria
- Evidence or history of clinically significant disease
- Subjects with asthma
- Subjects taking anti-leukotriene medications
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Identification of how inflammatory pathways differ in COPD subjects 6 weeks Identify how inflammatory pathways differ in subjects with COPD during an acute exacerbation relative to when the disease is stable.
- Secondary Outcome Measures
Name Time Method Biomarker Sample Repository 6 weeks Establish a biomarker sample repository to support future target validation for the treatment of subjects with COPD.
Trial Locations
- Locations (1)
Research Site
🇮🇪Dublin, Ireland