Evaluating Genes in Sputum to Measure Drug Response in COPD
Status:
Terminated
Trial end date:
2006-06-01
Target enrollment:
Participant gender:
Summary
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.