Clinical trial · Interventional
Randomized Trial of Fluticasone in Bronchial Premalignancy
The Influence of Fluticasone Inhalation on Intermediate Markers of Carcinogenesis in the Bronchial Epithelium of a High Risk Population : A Double Blind Placebo-Controlled Randomised Phase II Study
NCT00407264CI-TRIAL-00000524completedPhase 2ClinicalTrials.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)
The purpose of this study is to assess the efficacy of fluticasone on the development of lung cancer in smokers
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 |
|---|---|---|---|
| Bronchogenic Carcinoma | Bronchogenic Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fluticasone propionate | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Reversal of histological abnormality bronchial biopsies at 6 months
Secondary outcomes (3)
- measure
- Reversal of suprabasal p53 staining at 6 months
- measure
- Reversal of elevated hTERT mRNA levels at 6 months
- measure
- Reversal of increased KI-67 at 6 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * signed informed consent * age over 18 * metaplasia index \> 15% * over 25 pack years smoking history or history of lung- or head\&neck cancer * male/female of non-childbearing potential or using approved contraception Exclusion Criteria: * use of inhaled/systemic corticosteroid drugs in the preceding 12 months * contraindications for bronchoscopy/use of fluticasone * major illness * Baseline FEV1\<1000ml * Previous participation in clinical study * nodules \> 1cm on CT
References
Publications (2)
- BACKGROUNDWattenberg LW, Wiedmann TS, Estensen RD, Zimmerman CL, Galbraith AR, Steele VE, Kelloff GJ. Chemoprevention of pulmonary carcinogenesis by brief exposures to aerosolized budesonide or beclomethasone dipropionate and by the combination of aerosolized budesonide and dietary myo-inositol. Carcinogenesis. 2000 Feb;21(2):179-82. doi: 10.1093/carcin/21.2.179. PMID 10657955
- BACKGROUNDBreuer RH, Snijders PJ, Sutedja TG, v d Linden H, Risse EK, Meijer CJ, Postmus PE, Smit EF. Suprabasal p53 immunostaining in premalignant endobronchial lesions in combination with histology is associated with bronchial cancer. Lung Cancer. 2003 May;40(2):165-72. doi: 10.1016/s0169-5002(03)00029-1. PMID 12711117