Efficacy and safety of a new pressurised metered-dose inhaler formulation of budesonide/formoterol in children with asthma: A superiority and therapeutic equivalence study

Aim: This paediatric asthma study evaluated the efficacy and safety of a novel hydrofluoroalkane pressurised metered-dose inhaler (pMDI) formulation of budesonide/formoterol versus budesonide pMDI and budesonide/formoterol dry-powder inhaler (DPI). Methods: The Study was a 12-week, multinational, double-blind trial involving children (aged 6-11 years) with symptomatic asthma on inhaled corticosteroids (375-1000 mu g/day), with a history of exercise-induced bronchoconstriction and peak expiratory flow (PEF) >= 50% of predicted. Patients were randomised (two inhalations twice daily) to budesonide pMDI 100 mu g, budesonide/formoterol DPI 80/4.5 mu g or budesonide/formoterol pMDI 80/4.5 mu g. The primary endpoint was change from baseline in morning PEF. Results: Overall, 622 patients were randomised. Increases in morning PEF with budesonide/formoterol pMDI and budesonide/formoterol DPI were therapeutically equivalent (29.5 versus 30.21/min, respectively; 95% confidence interval: -6.0 to 4.6; P = 0.78, also confirmed by per-protocol analysis). Improvements in secondary efficacy endpoints with both budesonide/formoterol formulations were not significantly different. Significantly greater improvement was achieved with budesonide/formoterol pMDI versus budesonide pMDI for morning PEF (+9.61/min,; P<0.001) and other lung function parameters. The safety profile of budesonide/formoterol pMDI was favourable and similar to that of budesonide/formoterol DPI and budesonide pMDI. Conclusion: Budesonide/formoterol, administered via the therapeutically equivalent hydrofluoroalkane pMDI or DPI, is an effective and well-tolerated treatment for children with asthma. (C) 2007 Elsevier Ltd. All rights reserved.