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.
About flutiform®
flutiform® is a combination treatment for asthma, bringing together, for the first time, the inhaled corticosteroid (ICS) fluticasone propionate and the long-acting β2-agonist (LABA) formoterol fumarate in a single aerosol. The flutiform® aerosol inhaler is a modern design with a patient-facing, easy-to-read dose counter.4
In Europe, flutiform® is licensed for the regular treatment of asthma in patients aged 12 years and over when use of a combination product (an inhaled corticosteroid [ICS] and a long-acting β2-agonist [LABA]) is appropriate: for patients not adequately controlled with an ICS and an 'as required' inhaled short-acting β2-agonist or for patients already adequately controlled on both an ICS and a LABA. It is available in 18 countries across Europe including the UK, Germany, France, Netherlands and Italy.
About the study
A total of 512 patients aged 5 to <12yrs 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) in a double-blind, parallel group, multicentre study. The objectives were to demonstrate superiority of FP/FORM to FP and non-inferiority to FP/SAL. The primary endpoint was the change from predose FEV1 at baseline to 2-hour postdose FEV1 over the 12 weeks. The two key secondary endpoints were FEV1 AUC0-4h at Week 12 and change from pre-dose FEV1 over the 12 weeks.