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Clinical Trials: A Randomized Phase II Chemoprevention Study of Pioglitazone Versus Placebo in Patients at High Risk for Lung Cancer

 


A Randomized Phase II Chemoprevention Study of Pioglitazone Versus Placebo in Patients at High Risk for Lung Cancer


Trial Focus

Lung Cancer

Objective

         VA patients who are at high risk for developing lung cancer who have abnormal cells in their sputum. Patients will be randomized to take a new drug called Pioglitazone or a placebo. The study lasts for 7 months, and patients will see a doctor once amont

IRB Protocol #

08-0715

Trial Status

OPEN

Principle Investigator

ROBERT KEITH

Sponsor

Dept Of Veterans Affairs Medical Center

Contact

BRANDI BAGWELL at (303)724-1650 or BRANDI.BAGWELL@ucdenver.edu

Location

Dept Of Veterans Affairs Medical Center University of Colorado Hospital Dept Of Veterans Affairs Medical Center University of Colorado Hospital

Eligibility and Other Participant Information


What To Expect : Pioglitazone or a placebo. The study lasts for 7 months, and patients will see a doctor once amonth. They will be on the drug and/or placebo for 6 months. The following tests till be performed: Bronchoscopy (twice), routine and research blood samples, echocardiogram, chest CT. EKG, pulmonaty function test, and a carbon monoxide measurement. // Eligibility criteria : Adult > 18 years of age. A current or ex-smoker with a > 20 pack-year history of smoking. (An ex-smoker is defined as no tobacco use in the prior 6 months.). Mild or worse sputum cytologic atypia or endobronchial dysplasia on a previous bronchoscopy. At least mild airflow limitation on pulmonary function testing (FEV1/FVC 18 years of age. A current or ex-smoker with a > 20 pack-year history of smoking. (An ex-smoker is defined as no tobacco use in the prior 6 months.). Mild or worse sputum cytologic atypia or endobronchial dysplasia on a previous bronchoscopy. At least mild airflow limitation on pulmonary function testing (FEV1/FVC