A randomized phase IIb Trial of Pulmicort Turbuhaler (Budesonide) in people with dysplasia of the bronchial epithelium

Stephen Lam, Jean C. LeRiche, Annette McWilliams, Calum MacAulay, Yulia Dyachkova, Eva Szabo, John Mayo, Robert Schellenberg, Andy Coldmam, Ernest Hawk, Adi Gazdar

Research output: Contribution to journalArticlepeer-review

114 Scopus citations


Purpose: Preclinical studies suggest that inhaled budesonide may be an effective chemopreventive agent for lung cancer. We conducted a phase IIb study to determine the effects of inhaled budesonide in smokers with bronchial dysplasia. Experimental Design: A total of 112 smokers with more than or equal to one site of bronchial dysplasia > 1.2 mm in size identified by autofluorescence bronchoscopy-directed biopsy was randomly assigned to receive placebo or budesonide (Pulmicort Turbuhaler) 800 μg twice daily inhalation for 6 months. The primary end point was change in the histopathologic grade on repeat biopsy of the same sites at the end of 6 months. Results: There were no significant differences in the regression or progression rates of bronchial dysplasia between the two groups. There was a statistically significant but modest decrease in p53 and BelII expression in the bronchial biopsies after 6 months of Pulmicort Turbuhaler versus placebo (P = 0.01 and P = 0.001, respectively). There was a small but statistically significant decrease in the proportion of computed tomography-detected lung nodules after Pulmicort Turbuhaler compared with placebo (P = 0.024). Conclusions: Our results suggest that in smokers, inhaled budesonide in the dose of 1600 μg daily for 6 months had no effect in regression of bronchial dysplastic lesions or prevention of new lesions. Budesonide treatment resulted in a modest decrease in p53 and BclII. protein expression in bronchial biopsies and a slightly higher rate of resolution of computed tomography-detected lung nodules. Whether budesonide truly has an effect in preneoplastic lesions in the peripheral airways and alveoli requires additional investigation.

Original languageEnglish (US)
Pages (from-to)6502-6511
Number of pages10
JournalClinical Cancer Research
Issue number19
StatePublished - Oct 1 2004

ASJC Scopus subject areas

  • Oncology
  • Cancer Research


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