Mundipharma has reported results from a randomised, multicentre, Phase III trial of flutiform, a combination of fluticasone propionate and formoterol in a single pressurised metered dose inhaler, to treat paediatric asthma.
Presented at the European Respiratory Society (ERS) annual congress in Munich, Germany, the data showed the efficacy and tolerability of flutiform, over 12 weeks in children with asthma aged five years to less than 12 years.
The 12-week trial’s primary endpoint was change from predose FEV1 (forced expiratory volume; a key measure of lung capacity) at baseline to two-hour postdose FEV1.
The company said that flutiform (50/5µg 2 puffs BID) was superior to fluticasone propionate (50µg 2 puffs BID) and non-inferior compared to the commonly used combination fluticasone propionate/salmeterol (50/25µg 2 puffs BID) for the primary endpoint.
The trial also showed flutiform had a similar tolerability profile to fluticasone propionate and fluticasone propionate/salmeterol.
Office of Paediatric Allergology, Bialystok, Poland, principle trial investigator Dr Ploszczuk 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."
In the double-blind, parallel group, multicentre trial, a total of 512 patients aged five years to less than 12 years were randomised 1:1:1 to 12 weeks of treatment with either FP/FORM (100/10µg BID), FP (100µg BID) or fluticasone propionate/salmeterol (FP/SAL) (100/50µg BID).
According to the company, flutiform is not licensed for paediatric use but it is already available in 18 countries across Europe to treat adolescents aged 12 and above and adults with asthma.
The company is dedicated to research and development of new treatment options to help improve the lives of people affected by asthma.
Mundipharma International is licensed by Jagotec, a Skyepharma Group company, as the authorised distributor of the fluticasone/formoterol combination for Europe and most other territories outside Japan and the Americas.