Inflammation Clinical Trial
Official title:
Innate Immune Response in COPD
The purpose of this study is to determine whether the response of the immune system to bacterial components differs between patients with severe COPD compared to those with less severe COPD.
Status | Completed |
Enrollment | 30 |
Est. completion date | January 2008 |
Est. primary completion date | January 2008 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 50 Years to 89 Years |
Eligibility |
Inclusion Criteria: - post-bronchodilator FEV1/FVC <0.7 - FEV1 < 80% - > 10 pack-years tobacco smoking - no respiratory illnesses or prednisone or antibiotics in the last 4 weeks Exclusion Criteria: - Primary diagnosis of asthma - > 15% change in FEV1 - Chronic inflammatory or infectious disease - Cancer - Autoimmune disease - Chronic renal failure with a creatinine > 1.5 - Chronic liver disease - Chronic antibiotic use Note: Due to difficulty recruiting patients after 6 participants were enrolled, the exclusion criteria were modified to allow patients with > 15% change in FEV1. The exclusion criteria were also changed to allow chronic renal failure not requiring dialysis, and non-metastatic cancer provided there was no diagnosis of lung cancer. |
Observational Model: Cohort, Time Perspective: Cross-Sectional
Country | Name | City | State |
---|---|---|---|
United States | VA Puget Sound Health Care System | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
VA Puget Sound Health Care System | Novartis Pharmaceuticals, University of Washington |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cytokine production (TNF-alpha, IL-6, IL-8, IL-10, IL-1RA, G-CSF, IL-1B, MCP-1). | A whole blood stimulation assay was performed on blood samples from study participants. The whole blood was stimulated using several pathogen-associated molecular patterns that were agonists to seven different TLR receptors: 1) Pam3SCK4, 2) Zymosan, 3) FSL-1, 4) LPS, 5) flagellin, 6) R848. After stimulation with the PAMP, the cytokine levels (TNF-alpha, IL-6, IL-8, IL-10, IL-1RA, G-CSF, IL-1B, and MCP-1) were measured and the cytokine level results are in picograms per liter. Note, there is no treatment in this observational non-interventional trial. Therefore the multiple cytokine levels for each patient will not be aggregated or summarized into one measure. This study was a small pilot study and the results are exploratory. | This is a cross-sectional study with no follow-up period. Therefore the study outcomes were measured at the baseline visit (Time = day 0) | No |
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