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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jeffrey L. Curtis, University of Michigan
ClinicalTrials.gov Identifier:
NCT00281242
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 changes in sputum serial levels of two cytokines, interleukin (IL)-17 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:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • biomarker analysis at the time of exacerbation, no clinical outcome [ Time Frame: at each exacerbation ] [ Designated as safety issue: No ]

Enrollment: 37
Study Start Date: September 2005
Study Completion Date: July 2010
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 American Thoracic Society 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
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: NCT00281242

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), University of Michigan
ClinicalTrials.gov Identifier: NCT00281242     History of Changes
Other Study ID Numbers: 1325, R01HL082480
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:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Chronic Disease
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on October 19, 2014