We analysed data from 7042 patients, of whom 3801 were on inhaled budesonide and 3241 were on control
treatment, with 5212 patient-years of exposure to treatment. We recorded no signifi cant diff erence between treatment
groups for the occurrence of pneumonia as an adverse event (3% [n=122 patients] vs 3% [n=103]; adjusted hazard ratio
1·05, 95% CI 0·81–1·37) or a serious adverse event (1% [n=53] vs 2% [n=50]; 0·92, 0·62–1·35), or for time to
pneumonia as an adverse event (log-rank test 0·94) or a serious adverse event (0·61). Increasing age and decreasing
percent of predicted FEV1 were the only two variables that were signifi cantly associated with occurrence of pneumonia
as an adverse event or a serious adverse event.