Mundipharma announces results of pivotal phase III study for flutiform® in paediatric asthma
Posted: 8 September 2014 | | No comments yet
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…
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 to 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.1 The study also showed flutiform® had a similar tolerability profile to fluticasone propionate and fluticasone propionate/salmeterol.1
Asthma affects an estimated 30 million children and adults under 45 across Europe.2 Approximately one third of people in Europe will develop asthma at some time between the ages of 5 and 80, most before the age of 20.3 Asthma can place a significant burden upon families, for example, 13% of carers of children with asthma in Britain reported giving up work to care for their child.3
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.”
flutiform® is not licensed for paediatric use but it is already available for the treatment of adolescents aged 12 and above and adults with asthma and available in 18 countries across Europe.
Mundipharma is dedicated to research and development of innovative new treatment options to help improve the lives of people affected by asthma. This condition has a significant impact on people’s quality of life by affecting the most essential function: the ability to breathe.
Mundipharma International Corporation Limited is licensed by Jagotec AG, a Skyepharma Group company, as the authorised distributor of the fluticasone/formoterol combination for Europe and most other territories outside Japan and the Americas.
- Ploszczuk, A et al., Efficacy and safety of fluticasone propionate/formoterol in paediatric patients with asthma. European Respiratory Society annual conference, Abstract. Munich, Germany 6 – 10 September 2014.
- European Respiratory Society. The European Lung White Book. 2013
- European Lung Foundation: Childhood asthma http://www.europeanlung.org/en/lung-disease-and-information/lung-diseases/childhood-asthma accessed 23