Innate and Adaptive Immunity in Individuals Experiencing Chronic Obstructive Pulmonary Disease Exacerbations

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jeffrey L. Curtis, University of Michigan
ClinicalTrials.gov Identifier:
NCT00281216
First received: January 20, 2006
Last updated: July 15, 2013
Last verified: July 2013
  Purpose

The purpose of this study is to determine whether there is a statistical association between the changes from baseline in the levels of two cytokines interleukin (IL)-17A and IL-6 in the sputum of patients with chronic obstructive pulmonary disease (COPD) and the severity of acute exacerbations of COPD (AE-COPD). These sputum cytokine levels are taken as measures of the adaptive immune response (IL-17A) and the innate immune response (IL-6), respectively. Sputum will be collected either spontaneously or will be obtained by induction; cytokine levels will be measured by ELISA. The primary analysis, comparisons of sputum cytokine levels between clinical states, will be done using random effects modeling.


Condition
Pulmonary Disease, Chronic Obstructive
Lung Diseases
Lung Diseases, Obstructive

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Innate and Adaptive Immunity in COPD Exacerbations: Prospective Cohort Study

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • length of hospital stay [ Time Frame: hospital discharge ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

serum, sputum


Enrollment: 10
Study Start Date: September 2005
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Recruited from pulmonary and general medicine clinics

Criteria

Inclusion criteria:

  • Diagnosis of COPD (following American Thoracic Society guidelines) and/or chronic bronchitis
  • Forced Expiratory Volume in 1 second of less than 70% predicted value after bronchodilator
  • Current or former smokers with more than 20 pack-years
  • Daily productive cough for 3 months of the year for 2 consecutive years
  • At least one AE-COPD requiring medical attention in each year for the previous 3 years
  • Willingness to participate in follow-up studies defined in the protocol

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
  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: NCT00281216

Locations
United States, Michigan
University of Michigan at Ann Arbor
Ann Arbor, Michigan, United States, 48105
Sponsors and Collaborators
University of Michigan
Investigators
Study Chair: Jeffrey L. Curtis University of Michigan at Ann Arbor
  More Information

Additional Information:
Publications:
Responsible Party: Jeffrey L. Curtis, Professor of Internal Medicine (Pulmonary & Critical Care Medicine Division), University of Michigan
ClinicalTrials.gov Identifier: NCT00281216     History of Changes
Other Study ID Numbers: 1324, R01HL082480, R01 HL82480
Study First Received: January 20, 2006
Last Updated: July 15, 2013
Health Authority: United States: Federal Government

Keywords provided by University of Michigan:
Chronic Obstructive Pulmonary Disease
COPD

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

ClinicalTrials.gov processed this record on August 27, 2014