Status:
TERMINATED
Evaluating Genes in Sputum to Measure Drug Response in COPD
Lead Sponsor:
National Jewish Health
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Chronic Obstructive Pulmonary Disease (COPD)
Emphysema
Eligibility:
All Genders
40+ years
Phase:
NA
Brief 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 polym...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2006
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00233051
Start Date
April 1 2003
End Date
June 1 2006
Last Update
March 29 2017
Active Locations (1)
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1
National Jewish Medical and Research Center
Denver, Colorado, United States, 80206