Budesonide/formoterol vs formoterol, both via Turbuhaler®, in patients with moderate to severe COPD: Phase III study results

Background: This study evaluated the efficacy and tolerability of budesonide/formoterol (BUD/FORM) vs formoterol (FORM) in patients with moderate to severe COPD. Methods: In this randomised, double-blind, parallel-group, phase III study (NCT01069289) patients with moderate to severe COPD for ≥2 years received either BUD/FORM 160/4.5 µg 2 inhalations twice daily via Turbuhaler® or FORM 4.5 µg 2 inhalations twice daily via Turbuhaler® for 12 weeks. Reliever medication: salbutamol 100 μg/actuation via pMDI. Primary outcome variable: change from baseline over the treatment period in predose FEV 1 ; secondary outcome variables included: lung function, time to first exacerbation, tolerability. Results: 1293 patients were randomised. Both BUD/FORM and FORM improved predose FEV 1 (improvements of 4.6% and 1.5%, respectively); the change from baseline was significantly greater with BUD/FORM vs FORM (BUD/FORM:FORM ratio: 1.032; 95% CI: 1.013–1.052; p=0.0011). Significantly greater improvements in other lung function measures were also observed. BUD/FORM patients had a statistically significantly prolonged time to first exacerbation vs FORM patients (hazard ratio: 0.679; 95% CI: 0.507–0.909; p=0.0094). Both treatments were well tolerated. The incidence and type of adverse events were similar in both groups; most commonly reported adverse events (BUD/FORM vs FORM): COPD (8.0% vs 9.4%), nasopharyngitis (5.5% vs 4.9%) and bronchitis (2.0% vs 2.3%). Conclusions: BUD/FORM 160/4.5 µg two inhalations twice daily was more effective than FORM 4.5 µg two inhalations twice daily in patients with moderate to severe COPD. Both treatments were well tolerated. Funding: AstraZeneca.