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Evaluating Genes in Sputum to Measure Drug Response in COPD

This study has been terminated.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
National Jewish Health
ClinicalTrials.gov Identifier:
NCT00233051
First received: October 3, 2005
Last updated: July 19, 2011
Last verified: July 2011
History of Changes

October 3, 2005
July 19, 2011
April 2003
June 2006   (final data collection date for primary outcome measure)
Induced Sputum Gene Expression
Same as current
Complete list of historical versions of study NCT00233051 on ClinicalTrials.gov Archive Site
Lung Function
Same as current
Not Provided
Not Provided
 
Evaluating Genes in Sputum to Measure Drug Response in COPD
Expression of Inflammatory Mediators in Induced Sputum: A Potential Biomarker of Drug Response in COPD

The purpose of this research study is to determine whether analysis of genes in sputum is a useful noninvasive technique for measuring response to drugs in patients with COPD.

We propose to use polymerase chain reaction to evaluate gene expression in induced sputum from adult current smokers with moderate COPD, adult former smokers with moderate COPD. This study is designed to determine whether changes in expression of previously-identified inflammatory markers in induced sputum can be detected in response to drug therapy in COPD and to evaluate potential differences in the expression of these markers in adult smokers with and without COPD. Pre- and post-treatment serum will be obtained to facilitate proteomic analysis of therapeutic response as well. Changes in sputum gene expression in response to treatment will be the primary outcome variable in this study. Secondary outcomes will include changes in lung function, as well as changes in induced sputum inflammation. These endpoints will be evaluated before and directly after 6 weeks of randomly-assigned treatment with either salmeterol xinafoate or fluticasone propionate/50mcg salmeterol xinafoate combination DPI bid. Endpoints will be re-evaluated following a 4 week wash-out period.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Chronic Obstructive Pulmonary Disease (COPD)
  • Emphysema
  • Chronic Bronchitis
Drug: Salmeterol or Salmeterol/Fluticasone
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
20
June 2006
June 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Twenty adult subjects ≥ 40 years of age and ≥ 10 pack/year cigarette history will be evaluated.
  • Subjects will be recruited such that one-half are current smokers and one-half are former smokers.
  • All subjects will have COPD (FEV1/FVC < 70% and FEV1 => 40% predicted).
  • Airway hyperresponsiveness and diffusion capacity for carbon monoxide will also be performed to more precisely characterize the physiologic phenotype in these subjects.

Exclusion Criteria:

  • Subjects will be excluded if they have used inhaled or systemic corticosteroid or antibiotic use within 6 weeks or if they are currently treated with theophylline.
  • A 6 weeks run off after an upper respiratory infection will be required for qualifying subjects.
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00233051
HS-1728
Not Provided
E. Rand Sutherland, MD, MPH, National Jewish Health
National Jewish Health
GlaxoSmithKline
Principal Investigator: E Rand Sutherland, MD, MPH National Jewish Medical and Research Center Faculty
National Jewish Health
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP