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The efficacy and tolerability of budesonide/formoterol vs. formoterol in patients with moderate to severe chronic obstructive pulmonary disease (COPD) was evaluated.

METHODS: In this randomised, double-blind, parallel-group, phase III study (NCT01069289) patients with moderate to severe COPD for ≥2 years received either budesonide/formoterol 160/4.5 μg 2 inhalations twice daily (bid) via Turbuhaler(®) or formoterol 4.5 μg 2 inhalations bid via Turbuhaler(®) for 12 weeks. Salbutamol 100 μg/actuation via pMDI was available as reliever medication. Primary outcome variable: change from baseline to average during treatment in pre-dose FEV1 ; secondary outcome variables included lung function, COPD symptom measures, time to first exacerbation and tolerability.

RESULTS: 1293 patients were randomised (budesonide/formoterol n=636; formoterol n=657). Both budesonide/formoterol and formoterol increased pre-dose FEV1 vs. baseline (improvements of 4.6% and 1.5% over baseline, respectively), with the increase from baseline being significantly greater with budesonide/formoterol vs. formoterol (budesonide/formoterol:formoterol ratio 1.032; 95% CI: 1.013-1.052; p=0.0011). The budesonide/formoterol group had a significantly prolonged time to first exacerbation vs. the formoterol group (hazard ratio: 0.679; 95% CI: 0.507-0.909; p=0.0094) and significantly greater improvements in many secondary outcome measures. Both treatments were well tolerated; the incidence and type of adverse events were similar to most commonly reported adverse events (budesonide/formoterol vs. formoterol): COPD (8.0% vs. 9.4%) and nasopharyngitis (5.5% vs. 4.9%).

CONCLUSIONS: Budesonide/formoterol 160/4.5 μg two inhalations bid was effective and well tolerated in patients with moderate to severe COPD, offering benefits over formoterol alone in terms of improved lung function and reduced risk of exacerbation.