Beclomethasone/formoterol in the management of COPD: A randomised controlled trial

Objectives To evaluate the effect of beclomethasone/formoterol versus budesonide/formoterol (non inferiority) and versus formoterol (superiority) in patients with severe stable chronic obstructive pulmonary disease (COPD) Methods A double blind, double dummy, randomised, active controlled, parallel group study After 4 weeks run in with ipratropium/salbutamol (40/200 mu g, three times daily) patients were randomised to receive beclomethasone/formoterol (200/12 mu g pressurised metered dose inhaler), budesonide/formoterol (400/12 mu g dry powder inhaler) or formoterol (12 mu g dry powder inhaler) twice daily for 48 weeks Co primary efficacy variables were change from baseline to 48 weeks in pre dose morning forced expiratory volume in 1 s (FEV(1)) and mean rate of COPD exacerbations Results Of 718 patients randomised, 703 (232 beclomethasone/formoterol, 238 budesonide/formoterol, 233 formoterol) were in the ITT analysis Improvement in pre dose morning FEV(1) was 0 077 L, 0 080 L and 0 026 L for beclomethasone/formoterol, budesonide/formoterol and formoterol respectively (LS mean from the ANCOVA model) Beclomethasone/formoterol was not inferior to budesonide/formoterol (95% CI of the difference -0 052, 0 048) and superior to formoterol (p = 0 046) The overall rate of COPD exacerbations/patient/year was similar and not statistically significantly different among treatments (beclomethasone/formoterol 0 414, budesonide/formoterol 0 423 and formoterol 0 431) Quality of life and COPD symptoms improved in all groups and use of rescue medication decreased Safety profiles were as expected and treatments well tolerated Conclusions Beclomethasone/formoterol (400/24 mu g) treatment for 48 weeks improved pulmonary function, reduced symptoms compared to formoterol, was safe and well tolerated in patients with severe stable COPD Neither of the long acting beta 2 agonist/inhaled corticosteroid combinations affected the low exacerbation rate seen in this population (C) 2010 Published by Elsevier Ltd