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

This study is currently recruiting participants.

Verified by National Heart, Lung, and Blood Institute (NHLBI), July 2008

Sponsored by:	National Heart, Lung, and Blood Institute (NHLBI)
Information provided by:	National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:	NCT00281242

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

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)

U.S. FDA Resources

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

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

Biospecimen Retention: None Retained

Biospecimen Description:

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, 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

Publications:

Curtis JL, Freeman CM, Hogg JC. The immunopathogenesis of chronic obstructive pulmonary disease: insights from recent research. Proc Am Thorac Soc. 2007 Oct 1;4(7):512-21.

Freeman CM, Curtis JL, Chensue SW. CC chemokine receptor 5 and CXC chemokine receptor 6 expression by lung CD8+ cells correlates with chronic obstructive pulmonary disease severity. Am J Pathol. 2007 Sep;171(3):767-76. Epub 2007 Jul 19.

Responsible Party:	University of Michigan Health System ( Jeffrey L. Curtis, M.D. )
Study ID Numbers:	1325, R01 HL82480
Study First Received:	January 20, 2006
Last Updated:	July 28, 2008
ClinicalTrials.gov Identifier:	NCT00281242
Health Authority:	United States: Federal Government

Keywords provided by National Heart, Lung, and Blood Institute (NHLBI):

Chronic Obstructive Pulmonary Disease
COPD

Study placed in the following topic categories:

Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases

Respiration Disorders
Chronic Disease
Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:

Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on January 15, 2009