Clinical trial · Interventional
A Phase IIb Trial of Pulmicort Turbuhaler (Budesonide)
A Randomized Phase IIb Trial of Pulmicort Turbuhaler (Budesonide) in People With Dysplasia of the Bronchial Epithelium
NCT00175747CI-TRIAL-00000147completedPhase 2 / Phase 3ClinicalTrials.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)
Studies in animals suggest that inhaled budesonide may prevent the occurrence of lung cancer. We conducted a clinical trial to determine the effects of inhaled budesonide in smokers who had precancerous lesions in the breathing tubes (i.e. bronchial dysplasia.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Inhaled Budesonide 800 µg twice daily | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Rate of progression of bronchial dysplasia
Secondary outcomes (1)
- measure
- Number of pulmonary nodules on thoracic CT scanning and BCL-2 and p53 expression in the bronchial epithelial cells.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: * age \> 40 years; smoking history of 30 pack-years or more; normal organ function; sputum atypia Exclusion Criteria: * general debility that would prevent completion of 6 month follow-up; existing cancer diagnosis
References
Publications (1)
- RESULTLam S, leRiche JC, McWilliams A, Macaulay C, Dyachkova Y, Szabo E, Mayo J, Schellenberg R, Coldman A, Hawk E, Gazdar A. A randomized phase IIb trial of pulmicort turbuhaler (budesonide) in people with dysplasia of the bronchial epithelium. Clin Cancer Res. 2004 Oct 1;10(19):6502-11. doi: 10.1158/1078-0432.CCR-04-0686. PMID 15475437