Pioglitazone for Lung Cancer Chemoprevention
This trial evaluates the oral PPAR gamma agonist pioglitazone in a double-blind placebo
controlled trial. The high risk current and former smokers qualify based on tobacco
exposure, airflow limitation on lung function testing, and sputum cytologic atypia.
Subjects have a quantitative high resolution thoracic CT scan and a fluorescent bronchoscopy
at study entry and after 6 months on drug or placebo. Biologic samples are collected at both
time points. The primary outcome is endobronchial histology and determining if pioglitazone
can retard progression. Secondary endpoints related to the PPAR gamma signaling pathway
will also be analyzed.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Changes in endobronchial histology
Robert L. Keith, MD
VA Eastern Colorado Health Care System, Denver
United States: Federal Government
|VA Eastern Colorado Health Care System, Denver||Denver, Colorado 80220|
|Tennessee Valley Healthcare System Nashville Campus, Nashville, TN||Nashville, Tennessee 37212-2637|