Clinical trial · Interventional
Pioglitazone for Lung Cancer Chemoprevention
NCT00780234CI-TRIAL-00038075completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endobronchial Dysplasia | — | UNRESOLVED | — |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| fluorescence bronchoscopy | Procedure | — | UNRESOLVED |
| PIOGLITAZONE VS. PLACEBO 30 mg | Drug | — | UNRESOLVED |
| quantitative high resolution CT scan | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm 1: pioglitazone
- description
- Current or former smokers receive 6 months of treatment with pioglitazone
- interventionNames
- Procedure: fluorescence bronchoscopy
- Procedure: quantitative high resolution CT scan
- Drug: PIOGLITAZONE VS. PLACEBO 30 mg
- type
- PLACEBO_COMPARATOR
- label
- Arm 2: placebo
- description
- Current or former smokers receive 6 months of treatment with placebo
- interventionNames
- Procedure: fluorescence bronchoscopy
- Procedure: quantitative high resolution CT scan
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.