Pioglitazone for Lung Cancer Chemoprevention

Completed · Phase 2 · Has a placebo group

Conditions studied: Lung Cancer, Endobronchial Dysplasia

In brief

This is a chemoprevention trial evaluating the diabetic agent pioglitazone. Non-diabetic subjects at risk for lung cancer (based on smoking history, lung function testing, and atypical cells in a sputum sample) receive either placebo or pioglitazone and have chest computerized tomography (CAT) scans and examinations of their airways with a bronchoscope at the start of the trial and after 6 months on treatment. Compensation will be provided to the subject after completing the trial.

Key facts

Study ID

NCT00780234

Run by

VA Office of Research and Development

People needed

92

Starts

2009-08-01

Expected to finish

2017-08-01

Last updated by the study team

2019-04-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Current or former smoker (at least 10 pack years);
• One or more of the following:
• Mild or worse sputum atypia
• Airflow Limitation (FEV1/FVC<70% predicted)
• Biopsy proven airway dysplasia

You may not qualify if…

• myocardial infarction (MI) with ejection fraction < 50%;
• severe/unstable angina;
• history of coronary or peripheral arterial bypass grafting;
• New York Heart Association (NYHA) class III or IV congestive heart failure;
• hypoxemia (less than POX 90 with supplemental oxygen); Diabetes type I or II; severe COPD (GOLD stage III or IV); clinically significant edema requiring diuretic therapy;
• life expectancy < 6 months; history of bladder cancer
• pregnant or breast feeding; inability to give informed consent

Where it is running

• VA Eastern Colorado Health Care System, Denver, CO — Denver, Colorado, United States
• Tennessee Valley Healthcare System Nashville Campus, Nashville, TN — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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