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
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.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Prevention
Reversal of histological abnormality bronchial biopsies at 6 months
Egbert F Smit, MD PHD
Principal Investigator
VU University Medical Center
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
FPD2001
NCT00407264
February 2002
December 2005
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