Portal de Periódicos da CAPES

Beclomethasone/formoterol versus budesonide/formoterol combination therapy in asthma

2006; European Respiratory Society; Volume: 29; Issue: 4 Linguagem: Inglês

10.1183/09031936.00095906

1399-3003

Alberto Papi, Pierluigi Paggiaro, Gabriele Nicolini, Antonio M. Vignola, Leonardo M. Fabbri,

Inhalation and Respiratory Drug Delivery

The present study was designed to compare the fixed combination of beclomethasone and formoterol in a hydrofluoroalkane Modulite® (Chiesi Farmaceutici, Parma, Italy) pressurised metered-dose inhaler (pMDI), with a combination of budesonide and formoterol administered via a Turbuhaler® (AstraZeneca, Lund, Sweden) dry powder inhaler (DPI). This was a phase III, multinational, multicentre, double-blind, double-dummy, randomised, two-arm parallel groups, controlled study design. After a 2-week run-in period, 219 patients with moderate-to-severe asthma were randomised to a 12-week treatment with beclomethasone 200 μg plus formoterol 12 μg b.i.d. delivered via a pMDI or budesonide 400 μg plus formoterol 12 μg b.i.d. delivered via a DPI. The analysis of noninferiority on primary outcome, morning peak expiratory flow in the last 2 weeks of treatment, showed no difference between groups. A statistically significant improvement from baseline in lung function, symptoms and rescue medication use was observed in both groups at all time-points. No differences were observed between treatments in either rate of asthma exacerbations or frequency of adverse events. The new fixed combination of beclomethasone and formoterol in hydrofluoroalkane Modulite® pressurised metered-dose inhaler is equivalent to the marketed combination of budesonide and formoterol in terms of efficacy and tolerability profile.