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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by National Heart, Lung, and Blood Institute (NHLBI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00281216
First received: January 20, 2006
Last updated: July 14, 2009
Last verified: July 2009
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Estimated Enrollment: 100
Study Start Date: September 2005
Estimated Study Completion Date: July 2010
Estimated Primary Completion Date: July 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 ATS guidelines) and/or chronic bronchitis
  • FEV1 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00281216

Locations
United States, Michigan
University of Michigan at Ann Arbor Recruiting
Ann Arbor, Michigan, United States, 48105
Contact: Lisa McCloskey, BA, RRT     734-769-7100 ext 53533     lmcclosk@med.umich.edu    
Contact: Deborah Thompson, Ph.D.     734-764-7388     debthomp@med.umich.edu    
Principal Investigator: Jeffrey L. Curtis, M.D.            
Sub-Investigator: Fernando J Martinez, M.D., M.S.            
Sub-Investigator: MeiLan K Han, M.D., M.S            
Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Study Chair: Jeffrey L. Curtis University of Michigan at Ann Arbor
  More Information

Additional Information:
Curtis Laboratory  This link exits the ClinicalTrials.gov site
COPD Foundation  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Jeffrey L. Curtis, M.D., University of Michigan Health System
ClinicalTrials.gov Identifier: NCT00281216     History of Changes
Other Study ID Numbers: 1324, R01 HL82480
Study First Received: January 20, 2006
Last Updated: July 14, 2009
Health Authority: United States: Federal Government

Keywords provided by National Heart, Lung, and Blood Institute (NHLBI):
Chronic Obstructive Pulmonary Disease
COPD

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

ClinicalTrials.gov processed this record on May 23, 2013