Randomized Trial of Fluticasone in Bronchial Premalignancy

Amsterdam UMC, location VUmc

Status and phase: Completed; Phase 2

Conditions: Bronchogenic Carcinoma

Treatments: Drug: Fluticasone propionate

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00407264

FPD2001

FLU 00-02

Details and patient eligibility

About

The purpose of this study is to assess the efficacy of fluticasone on the development of lung cancer in smokers

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind