Budesonide in Treating Former and Current Smokers With Bronchial Dysplasia
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of budesonide may be an effective way to prevent bronchial dysplasia.
PURPOSE: Randomized double-blinded phase II trial to determine the effectiveness of budesonide in treating former or current smokers who have bronchial dysplasia.
|Study Design:||Allocation: Randomized
Primary Purpose: Prevention
|Official Title:||A Phase II Trial of Inhaled Budesonide (Pulmicort Turbuhaler) in Persons With Dysplasia of the Bronchial Epithelium|
|Study Start Date:||July 2000|
OBJECTIVES: I. Determine the efficacy of inhaled budesonide on the number and grade of bronchial epithelial dysplastic lesions in former and current smokers. II. Compare the effect of inhaled budesonide vs placebo in modulating several intermediate biomarkers (i.e., proliferation, apoptosis, morphometric, and methylation markers) in this patient population. III. Correlate the regression of bronchial dysplasia (number and grade) and improvement in sputum cytology (morphometric grade of atypical cells) with the modulations in molecular biomarkers in this patient population. IV. Compare the stability of the chemopreventive effect of these treatment regimens at six months after completion of these regimens in these patients. V. Compare the safety of these treatment regimens in these patients.
OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are stratified according to gender, smoking status (current vs former), and morphometric index (no greater than 3.4 vs greater than 3.4). Patients are randomized into one of two treatment arms. Arm I: Patients receive inhaled budesonide twice daily. Arm II: Patients receive an inhaled placebo twice daily. Treatment continues for 6 months in the absence of disease progression or unacceptable toxicity. Patients are followed at 7 months and 12 months.
PROJECTED ACCRUAL: A total of 110 patients (55 per treatment arm) will be accrued for this study within 15 months.
|Canada, British Columbia|
|British Columbia Cancer Agency|
|Vancouver, British Columbia, Canada, V5Z 4E6|
|Study Chair:||Stephen Lam, MD||British Columbia Cancer Agency|