Text Size

Changes in Cytokine Levels During an Acute Exacerbation of Chronic Obstructive Pulmonary Disease

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:
NCT00281242
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 changes in sputum serial levels of two cytokines, interleukin (IL)-17A and IL-6, during the treatment course of a severe acute exacerbation of chronic obstructive pulmonary disease (AE-COPD) and during the clinical course itself (i.e., rate of recovery or potential complicated course). AE-COPD is defined as an episode requiring emergency room (ER) evaluation.


Condition
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Innate and Adaptive Immunity in COPD Exacerbations: Severe AE-COPD Clinical Course 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

Emergency room and clinics

Criteria

Inclusion criteria:

  • Diagnosis of COPD (following ATS guidelines) and/or chronic bronchitis
  • ER visit and/or hospitalization with AE-COPD
  • Current or former smokers with more than 20 pack-years
  • Willingness to participate in follow-up studies defined in the protocol
  • Ability to give informed consent

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: NCT00281242

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     lmlccosk@med.umich.edu    
Contact: Deborah Thompson, Ph.D.     734-764-7388     debthomp@med.umich.edu    
Principal Investigator: Jeffrey L. Curtis, MD            
Sub-Investigator: Fernando J. Martinez, MD, MS            
Sub-Investigator: MeiLan K Han, MD, MS            
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: NCT00281242     History of Changes
Other Study ID Numbers: 1325, 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 22, 2013