Innate Immune Response in COPD

NCT02637219 | Completed

• 1 other identifier: 01439
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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)

Eligibility Criteria

• Age: 50 Years - 89 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with a clinical history of COPD recruited from a pulmonary subspecialty clinic at an academic medical center

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Puget Sound Health Care System: lead
• University of Washington: collaborator
• Novartis Pharmaceuticals: collaborator

Study Sites (1)

VA Puget Sound Health Care System

Seattle, Washington, 98108, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Inflammation; Bronchitis, Chronic

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases

Study Officials

• Vincent Fan, MD MPH

  VA Puget Sound Health Care System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 3, 2015
• First Posted: December 22, 2015
• Study Start: March 1, 2006
• Primary Completion: January 1, 2008
• Study Completion: January 1, 2008
• Last Updated: December 22, 2015

Record last verified: 2015-12

Locations

US (1)