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

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• 作者：Alyn H. Morice ; Stefan Peterson ; Ola Beckman ; Zuzana Kukova
• 关键词：Asthma ; Budesonide/formoterol ; Dry-powder inhaler ; Equivalence ; Pressurised metered-dose inhaler
• 刊名：Pulmonary Pharmacology & Therapeutics
• 出版年：2008
• 出版时间：February 2008
• 年：2008
• 卷：21
• 期：1
• 页码：152-159
• 全文大小：308 K

文摘

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 che/MiamiImageURL/B6WPM-4N25VY7-1-15/0?wchp=dGLbVzb-zSkWW"" alt=""Click to view the MathML source"" align=""absbottom"" border=""0"" height=17 width=134>, 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 che/MiamiImageURL/B6WPM-4N25VY7-1-17/0?wchp=dGLbVzb-zSkWW"" alt=""Click to view the MathML source"" align=""absbottom"" border=""0"" height=16 width=43>, budesonide/formoterol DPI che/MiamiImageURL/B6WPM-4N25VY7-1-18/0?wchp=dGLbVzb-zSkWW"" alt=""Click to view the MathML source"" align=""absbottom"" border=""0"" height=17 width=64> or budesonide/formoterol pMDI che/MiamiImageURL/B6WPM-4N25VY7-1-1B/0?wchp=dGLbVzb-zSkWW"" alt=""Click to view the MathML source"" align=""absbottom"" border=""0"" height=17 width=64>. 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 to 4.6; 8057df544cc38a28309e6b217be470"" title=""Click to view the MathML source"">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 (+9.6 l/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.