Pulmonary Disease, Chronic Obstructive Clinical Trial
Official title:
Innate and Adaptive Immunity in COPD Exacerbations: Prospective Cohort Study
Verified date | January 2016 |
Source | University of Michigan |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Observational |
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.
Status | Completed |
Enrollment | 10 |
Est. completion date | September 2010 |
Est. primary completion date | September 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 40 Years to 80 Years |
Eligibility |
Inclusion criteria: - 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 Exclusion criteria: - 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 |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | University of Michigan at Ann Arbor | Ann Arbor | Michigan |
Lead Sponsor | Collaborator |
---|---|
University of Michigan | National Heart, Lung, and Blood Institute (NHLBI) |
United States,
Curtis JL, Freeman CM, Hogg JC. The immunopathogenesis of chronic obstructive pulmonary disease: insights from recent research. Proc Am Thorac Soc. 2007 Oct 1;4(7):512-21. Review. — View Citation
Freeman CM, Curtis JL, Chensue SW. CC chemokine receptor 5 and CXC chemokine receptor 6 expression by lung CD8+ cells correlates with chronic obstructive pulmonary disease severity. Am J Pathol. 2007 Sep;171(3):767-76. Epub 2007 Jul 19. — View Citation
Freeman CM, Han MK, Martinez FJ, Murray S, Liu LX, Chensue SW, Polak TJ, Sonstein J, Todt JC, Ames TM, Arenberg DA, Meldrum CA, Getty C, McCloskey L, Curtis JL. Cytotoxic potential of lung CD8(+) T cells increases with chronic obstructive pulmonary diseas — View Citation
Freeman CM, Martinez CH, Todt JC, Martinez FJ, Han MK, Thompson DL, McCloskey L, Curtis JL. Acute exacerbations of chronic obstructive pulmonary disease are associated with decreased CD4+ & CD8+ T cells and increased growth & differentiation factor-15 (GD — View Citation
Freeman CM, Martinez FJ, Han MK, Ames TM, Chensue SW, Todt JC, Arenberg DA, Meldrum CA, Getty C, McCloskey L, Curtis JL. Lung dendritic cell expression of maturation molecules increases with worsening chronic obstructive pulmonary disease. Am J Respir Cri — View Citation
Freeman CM, Martinez FJ, Han MK, Washko GR Jr, McCubbrey AL, Chensue SW, Arenberg DA, Meldrum CA, McCloskey L, Curtis JL. Lung CD8+ T cells in COPD have increased expression of bacterial TLRs. Respir Res. 2013 Feb 1;14:13. doi: 10.1186/1465-9921-14-13. — View Citation
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Primary | length of hospital stay | hospital discharge | No |
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