Pulmonary Disease, Chronic Obstructive Clinical Trial
Official title:
Innate and Adaptive Immunity in COPD Exacerbations: Severe AE-COPD Clinical Course 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 changes in sputum serial levels of two cytokines, interleukin (IL)-17 and IL-6, during the treatment course of a severe acute exacerbation of chronic obstructive pulmonary disease (AE-COPD) and during the clinical course itself (i.e., rate of recovery or potential complicated course). AE-COPD is defined as an episode requiring emergency room (ER) evaluation.
Status | Completed |
Enrollment | 37 |
Est. completion date | July 2010 |
Est. primary completion date | June 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 - ER visit and/or hospitalization with AE-COPD - Current or former smokers with more than 20 pack-years - Willingness to participate in follow-up studies defined in the protocol - Ability to give informed consent 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
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | biomarker analysis at the time of exacerbation, no clinical outcome | at each exacerbation | No |
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