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Innate Immune Response in COPD

This study has been completed.
Sponsor:
Collaborators:
University of Washington
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Vincent S. Fan, VA Puget Sound Health Care System
ClinicalTrials.gov Identifier:
NCT02637219
First received: December 3, 2015
Last updated: December 18, 2015
Last verified: December 2015
  Purpose
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.

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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Innate Immune Response in COPD

Further study details as provided by Vincent S. Fan, VA Puget Sound Health Care System:

Primary Outcome Measures:
  • Cytokine production (TNF-alpha, IL-6, IL-8, IL-10, IL-1RA, G-CSF, IL-1B, MCP-1). [ Time Frame: This is a cross-sectional study with no follow-up period. Therefore the study outcomes were measured at the baseline visit (Time = day 0) ]
    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.


Enrollment: 30
Study Start Date: March 2006
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   50 Years to 89 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02637219

Locations
United States, Washington
VA Puget Sound Health Care System
Seattle, Washington, United States, 98108
Sponsors and Collaborators
VA Puget Sound Health Care System
University of Washington
Novartis Pharmaceuticals
Investigators
Principal Investigator: Vincent Fan, MD MPH VA Puget Sound Health Care System
  More Information

Responsible Party: Vincent S. Fan, Associate Professor, VA Puget Sound Health Care System
ClinicalTrials.gov Identifier: NCT02637219     History of Changes
Other Study ID Numbers: 01439
Study First Received: December 3, 2015
Last Updated: December 18, 2015

Additional relevant MeSH terms:
Lung Diseases
Inflammation
Chronic Disease
Pulmonary Disease, Chronic Obstructive
Bronchitis
Bronchitis, Chronic
Respiratory Tract Diseases
Pathologic Processes
Disease Attributes
Lung Diseases, Obstructive
Bronchial Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on August 22, 2017