Evaluating Genes in Sputum to Measure 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.
Chronic Obstructive Pulmonary Disease (COPD)
Drug: Salmeterol or Salmeterol/Fluticasone
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Expression of Inflammatory Mediators in Induced Sputum: A Potential Biomarker of Drug Response in COPD|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00233051
|United States, Colorado|
|National Jewish Medical and Research Center|
|Denver, Colorado, United States, 80206|
|Principal Investigator:||E Rand Sutherland, MD, MPH||National Jewish Medical and Research Center Faculty|