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

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: NCT00281216
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 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 or disease
Pulmonary Disease, Chronic Obstructive Lung Diseases Lung Diseases, Obstructive

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 10 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Innate and Adaptive Immunity in COPD Exacerbations: Prospective Cohort Study
Study Start Date : September 2005
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Primary Outcome Measures :
  1. length of hospital stay [ Time Frame: hospital discharge ]

Biospecimen Retention:   Samples Without DNA
serum, sputum

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
Recruited from pulmonary and general medicine clinics

Inclusion criteria:

  • Diagnosis of COPD (following American Thoracic Society guidelines) and/or chronic bronchitis
  • Forced Expiratory Volume in 1 second 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

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): NCT00281216

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 Division), University of Michigan Identifier: NCT00281216     History of Changes
Other Study ID Numbers: 1324
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