Phase 2
N=92
Pioglitazone for Lung Cancer Chemoprevention
Lung Cancer · Endobronchial Dysplasia
Bottom Line
View on ClinicalTrials.gov: NCT00780234 ↗Enrolled (actual)
92
Serious AEs
8.7%
Results posted
Apr 2019
Primary outcome: Primary: 6-month Histology Score — 3.07; 3.71 Units on a scale — p=0.53
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- fluorescence bronchoscopy (Procedure); quantitative high resolution CT scan (Procedure); PIOGLITAZONE VS. PLACEBO 30 mg (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Jun 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 6-month Histology Score |
3.07; 3.71 | 0.53 |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00780234). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.