Evaluating Genes in Sputum to Measure Drug Response in COPD
Information source: National Jewish Medical and Research Center
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Obstructive Pulmonary Disease (COPD); Emphysema; Chronic Bronchitis
Intervention: Salmeterol or Salmeterol/Fluticasone (Drug)
Sponsored by: National Jewish Medical and Research Center
Official(s) and/or principal investigator(s):
E Rand Sutherland, MD, MPH, Principal Investigator, Affiliation: National Jewish Medical and Research Center Faculty
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.
Official title: Expression of Inflammatory Mediators in Induced Sputum: A Potential Biomarker of Drug Response in COPD
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Primary outcome: Induced Sputum Gene Expression
Secondary outcome: Lung Function
Minimum age: 40 Years.
Maximum age: N/A.
- Twenty adult subjects ≥ 40 years of age and ≥ 10 pack/year cigarette history will be
- Subjects will be recruited such that one-half are current smokers and one-half are
- 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.
- 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
Locations and Contacts
National Jewish Medical and Research Center, Denver, Colorado 80206, United States
clinical lab website within National Jewish Medical and Research Center
Starting date: April 2003
Last updated: June 21, 2006