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Innate Immune Response in COPD

NCT ID: NCT02637219

Last Updated: 2015-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-03-31

Study Completion Date

2008-01-31

Brief Summary

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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.

Detailed Description

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The airways of COPD patients are often colonized with bacteria leading to increased airway inflammation. This study sought to determine whether systemic cytokine responses to microbial pathogen-associated molecular patterns (PAMPs) are increased among subjects with severe COPD.

In an observational cross-sectional study of COPD subjects, PAMP-induced cytokine responses were measured in whole blood ex vivo. We used PAMPs derived from microbial products recognized by TLR 1, 2, 4, 5, 6, 7, and 8. Patterns of cytokine response to PAMPs were assessed using hierarchical clustering. One-sided t-tests were used to compare PAMP-induced cytokine levels in blood from patients with and without severe COPD, and for subjects with and without chronic bronchitis.

Conditions

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Pulmonary Disease, Chronic Obstructive Immunity, Innate Inflammation Bronchitis, Chronic Toll-Like Receptors

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

89 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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University of Washington

OTHER

Sponsor Role collaborator

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role collaborator

VA Puget Sound Health Care System

FED

Sponsor Role lead

Responsible Party

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Vincent S. Fan

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Vincent Fan, MD MPH

Role: PRINCIPAL_INVESTIGATOR

VA Puget Sound Health Care System

Locations

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VA Puget Sound Health Care System

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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01439

Identifier Type: -

Identifier Source: org_study_id