A Phase IIb Trial of Pulmicort Turbuhaler (Budesonide)

Summary

Studies in animals suggest that inhaled budesonide may prevent the occurrence of lung cancer. We conducted a clinical trial to determine the effects of inhaled budesonide in smokers who had precancerous lesions in the breathing tubes (i.e. bronchial dysplasia.

Timeline

Start

2000-01

Primary completion

—

Completion

2002-12

Outcome

Missed primary endpoint

paper There were no significant differences in the regression or progression rates of bronchial dysplasia between the two groups. PMID 15475437 ↗

Publications

• Results Lam S, leRiche JC, McWilliams A, Macaulay C, Dyachkova Y, Szabo E, Mayo J, Schellenberg R, Coldman A, Hawk E, Gazdar A. A randomized phase IIb trial of pulmicort turbuhaler (budesonide) in people with dysplasia of the bronchial epithelium. Clin Cancer Res. 2004 Oct 1;10(19):6502-11. doi: 10.1158/1078-0432.CCR-04-0686.

Drugs

Indications