Randomized Trial of Fluticasone in Bronchial Premalignancy
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The purpose of this study is to assess the efficacy of fluticasone on the development of lung cancer in smokers
Condition or disease
Drug: Fluticasone propionate
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.
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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