Budesonide/formoterol: in chronic obstructive pulmonary disease.

Budesonide/formoterol is a fixed-dose combination of the corticosteroid budesonide and the long-acting beta2-agonist formoterol, and is inhaled via the Turbuhaler device. In two large, randomised, double-blind, 12-month studies, patients with severe chronic obstructive pulmonary disease (COPD) receiving budesonide/formoterol 320/9 microg twice daily had a significantly higher forced expiratory volume in 1 second (FEV1) and significantly higher morning and evening peak expiratory flow at trial endpoint than recipients of budesonide or placebo; FEV1 was significantly higher than with formoterol in the larger study. In both studies, the rate of COPD exacerbations and exacerbations requiring oral corticosteroids was significantly reduced with budesonide/formoterol versus formoterol and placebo. Moreover, the time to first exacerbation was significantly prolonged with budesonide/formoterol versus all other treatment arms in the larger study. At 12 months, significant improvements in health-related quality-of-life scores were seen with budesonide/formoterol versus placebo in both studies. The reduction in total and individual symptom scores was significantly greater with budesonide/formoterol than with budesonide or placebo in the smaller study. Budesonide/formoterol was generally well tolerated by patients with severe COPD. The tolerability profile of the combination was similar to that of the individual components with no increase in the incidence of adverse events.

RCT Entities:   Population Interventions Outcomes