A Phase II Trial of Inhaled Budesonide (Pulmicort Turbuhaler) in Persons With Dysplasia of the Bronchial Epithelium
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.
Allocation: Randomized, Primary Purpose: Prevention
Stephen Lam, MD
British Columbia Cancer Agency
United States: Federal Government