Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
An Exploratory Study of the Cellular Inflammatory Mechanisms Associated With Chronic Obstructive Pulmonary Disease Exacerbations
Verified date | August 2012 |
Source | MedImmune LLC |
Contact | n/a |
Is FDA regulated | No |
Health authority | Ireland: Research Ethics Committee |
Study type | Observational |
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).
Status | Completed |
Enrollment | 26 |
Est. completion date | February 2012 |
Est. primary completion date | January 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 40 Years to 85 Years |
Eligibility |
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 |
Observational Model: Case-Only, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Ireland | Research Site | Dublin |
Lead Sponsor | Collaborator |
---|---|
MedImmune LLC |
Ireland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Identification of how inflammatory pathways differ in COPD subjects | Identify how inflammatory pathways differ in subjects with COPD during an acute exacerbation relative to when the disease is stable. | 6 weeks | No |
Secondary | Biomarker Sample Repository | Establish a biomarker sample repository to support future target validation for the treatment of subjects with COPD. | 6 weeks | No |
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