Date: 2014-09-06
Type of information: Presentation of results at a congress
phase: 3
Announcement: presentation of results at ERS International Congress 2014, the annual meeting of the European Respiratory Society
Company: Skyepharma (UK) Mundipharma (UK)
Product: flutiform® (fluticasone propionate and formoterol)
Action
mechanism: flutiform® combines fluticasone propionate (fluticasone), an inhaled corticosteroid (ICS), and formoterol fumarate (formoterol), a long-acting β2-agonist (LABA), in a single aerosol inhaler incorporating Skyepharma\'s proprietary SkyeDry™ technology. In Europe, flutiform® is indicated for the regular treatment of asthma in patients aged 12 years and over (50/5µg and 125/5µg strengths) and in adults (250/10µg strength) whose symptoms are not adequately controlled on an ICS and an as-required inhaled short-acting β2-agonist (SABA), and in those patients who are already receiving treatment with both an ICS and LABA. Mundipharma International Corporation Limited is licensed by Skyepharma as the authorised distributor of the fluticasone/formoterol combination for Europe and most other territories outside Japan and the Americas.
Disease: paediatric asthma
Therapeutic area: Allergic diseases - Immunological diseases - Respiratory diseases
Country:
Trial details:
Latest
news: * On September 6, 2014, Skyepharma announced that new data from a randomised, multicentre, pivotal phase III study of flutiform® for the treatment of paediatric asthma has been presented at the European Respiratory Society (ERS) annual congress in Munich, Germany, (6-10 September 2014) by its licensing partner Mundipharma. The data shows the efficacy and tolerability of flutiform® , a combination of fluticasone propionate and formoterol in a single pressurised metered dose inhaler, in children with asthma aged 5 to period. flutiform® (50/5µg 2 puffs twice per day) was superior to fluticasone propionate (50µg 2 puffs twice per day) and non-inferior compared with the commonly used combination fluticasone propionate/salmeterol (50/25µg 2 puffs twice per day) for the primary endpoint. The study also showed flutiform® had a similar tolerability profile to fluticasone propionate and fluticasone propionate/salmeterol. flutiform® is not licensed for paediatric use but it is already available in 18 countries across Europe for the treatment of asthma in adults as well as in adolescents aged 12 and above.
