Randomized Trial of Fluticasone in Bronchial Premalignancy
- Conditions
- Bronchogenic Carcinoma
- Registration Number
- NCT00407264
- Lead Sponsor
- Amsterdam UMC, location VUmc
- Brief Summary
The purpose of this study is to assess the efficacy of fluticasone on the development of lung cancer in smokers
- Detailed Description
Bronchial epithelium exposed to cigarette smoke undergoes a series of histological changes that may ultimately lead to invasive cancer. In rats exposed to cigarette smoke inhaled corticosteroids reduce the number of lung tumors. The purpose of this study is to assess the efficacy of fluticasone on premalignant lesions in volunteers with a smoking history of \>10 pack-years and patients cured of head and neck cancer or lung cancer. Participants are screened for premalignant lesions by bronchoscopy and if these are present randomised to receive a powder inhalation device containing either fluticasone 500 μg or a placebo. After 6 months, biopsies are taken from the same locations. Efficacy of treatment is assessed by reversal of metaplasia/dysplasia; secondary end-points are reversal of increased p53 immunoreactivity and hTERT expression.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 90
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Reversal of histological abnormality bronchial biopsies at 6 months
- Secondary Outcome Measures
Name Time Method Reversal of suprabasal p53 staining at 6 months Reversal of elevated hTERT mRNA levels at 6 months Reversal of increased KI-67 at 6 months
Trial Locations
- Locations (2)
the Netherlands Cancer Institute / Antoni van Leeuwenhoek Hospital
🇳🇱Amsterdam, Netherlands
VU medical center
🇳🇱Amsterdam, Netherlands