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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00281242
Recruitment Status : Completed
First Posted : January 24, 2006
Last Update Posted : January 29, 2016
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Jeffrey L. Curtis, University of Michigan

Brief Summary:
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 or disease Intervention/treatment
Pulmonary Disease, Chronic Obstructive Lung Diseases, Obstructive Other: blood draw

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 37 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Innate and Adaptive Immunity in COPD Exacerbations: Severe AE-COPD Clinical Course Study
Study Start Date : September 2005
Actual Primary Completion Date : June 2010
Actual Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Group/Cohort Intervention/treatment
Research subjects
All participants undergo the same testing in this observational trial. There is no randomization, and no interventions other than blood drawing.
Other: blood draw
All subjects undergo blood draws at study visits and at the time of COPD exacerbation visits.

Primary Outcome Measures :
  1. biomarker analysis at the time of exacerbation, no clinical outcome [ Time Frame: at each exacerbation ]

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Emergency room and clinics

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00281242

United States, Michigan
University of Michigan at Ann Arbor
Ann Arbor, Michigan, United States, 48105
Sponsors and Collaborators
University of Michigan
National Heart, Lung, and Blood Institute (NHLBI)
Study Chair: Jeffrey L. Curtis University of Michigan at Ann Arbor

Additional Information:
Publications of Results:
Other Publications:
Responsible Party: Jeffrey L. Curtis, Professor of Internal Medicine (Pulmonary & Critical Care Medicine), University of Michigan Identifier: NCT00281242     History of Changes
Other Study ID Numbers: 1325
R01HL082480 ( U.S. NIH Grant/Contract )
First Posted: January 24, 2006    Key Record Dates
Last Update Posted: January 29, 2016
Last Verified: January 2016

Keywords provided by Jeffrey L. Curtis, University of Michigan:
Chronic Obstructive Pulmonary Disease

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