Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial
Official title:
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.
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