Mundipharma announces results of pivotal phase III study for flutiform in paediatric asthma

New data from a randomised, multicentre, phase III study, being presented at the European Respiratory Society (ERS) annual congress in Munich, Germany, supports the potential of flutiform for the treatment of paediatric asthma. The data being presented shows the efficacy and tolerability of flutiform, a combination of fluticasone propionate and formoterol in a single pressurised metered dose inhaler, over 12 weeks in children with asthma aged 5 to <12.

The primary endpoint of this 12-week study was change from predose FEV1 (forced expiratory volume; a key measure of lung capacity) at baseline to 2-hour postdose FEV1.1 flutiform (50/5μg 2 puffs BID) was superior to fluticasone propionate (50μg 2 puffs BID) (treatment difference = 0.07L; 95%CI: 0.03, 0.11; P<0.001) and non-inferior compared with the commonly used combination fluticasone propionate/salmeterol (50/25μg 2 puffs BID) (treatment difference = -0.00L; 95%CI: -0.04, 0.04; P<0.001) for the primary endpoint. The study also showed flutiform had a similar tolerability profile to fluticasone propionate and fluticasone propionate/salmeterol.

Commenting on the results, principle trial investigator Dr Ploszczuk from Office of Paediatric Allergology, Białystok, Poland, said: “Living with asthma can have a significant impact on many children and our clinical goal is to help them gain control of their disease. Flutiform has already been approved as a maintenance therapy for asthma in adults and adolescents and this data suggests it also has the potential to be an important new treatment option for paediatric patients.”