Innate and Adaptive Immunity in Individuals Experiencing Chronic Obstructive Pulmonary Disease Exacerbations
Completed
Conditions studied: Pulmonary Disease, Chronic Obstructive, Lung Diseases, Lung Diseases, Obstructive
In brief
The purpose of this study is to determine whether there is a statistical association between the changes from baseline in the levels of two cytokines interleukin (IL)-17A and IL-6 in the sputum of patients with chronic obstructive pulmonary disease (COPD) and the severity of acute exacerbations of COPD (AE-COPD). These sputum cytokine levels are taken as measures of the adaptive immune response (IL-17A) and the innate immune response (IL-6), respectively. Sputum will be collected either spontaneously or will be obtained by induction; cytokine levels will be measured by ELISA. The primary analysis, comparisons of sputum cytokine levels between clinical states, will be done using random effects modeling.
Key facts
- Study ID
- NCT00281216
- Run by
- University of Michigan
- People needed
- 10
- Starts
- 2005-09-01
- Expected to finish
- 2010-09-01
- Last updated by the study team
- 2016-01-29
Who can join
Age: 40 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Diagnosis of COPD (following American Thoracic Society guidelines) and/or chronic bronchitis
- Forced Expiratory Volume in 1 second of less than 70% predicted value after bronchodilator
- Current or former smokers with more than 20 pack-years
- Daily productive cough for 3 months of the year for 2 consecutive years
- At least one AE-COPD requiring medical attention in each year for the previous 3 years
- Willingness to participate in follow-up studies defined in the protocol
You may not qualify if…
- Unstable cardiovascular disease
- Other systemic disease in which survival of more than 2 years is unlikely
- Mental incompetence or active psychiatric illness
- Currently taking more than 20 mg/day of Prednisone
- Participation in another experimental protocol within 6 weeks of study entry
- Asthma
- Cystic fibrosis
- Clinically significant bronchiectasis
- Lung cancer
- Other inflammatory or fibrotic lung disease
Where it is running
- University of Michigan at Ann Arbor — Ann Arbor, Michigan, United States
Full record on ClinicalTrials.gov
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