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 (375–1000μg/day), with a history of exercise-induced bronchoconstriction and peak expiratory flow (PEF) ⩾50%⩾50% of predicted. Patients were randomised (two inhalations twice daily) to budesonide pMDI 100μg, budesonide/formoterol DPI 80/4.5μg or budesonide/formoterol pMDI 80/4.5μg. 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 30.2 l/min, respectively; 95% confidence interval: -6.0-6.0 to 4.64.6; P=0.78P=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 (+9.6+9.6 l/min; P<0.001P<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.