CompletedPhase 2

Pioglitazone for Lung Cancer Chemoprevention

United States92 participantsStarted 2009-08

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

What they're measuring

6-month Histology Score

Timeframe: 6 months

Trial details

NCT IDNCT00780234

SponsorVA Office of Research and Development

Sponsor typeFED

Study typeINTERVENTIONAL

Primary completion2016-06

Results submitted2018-12-20

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