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Good efficacy and safety profile of flutiform in asthma patients seen in ERS-presented studies

Data presented at the European Respiratory Society (ERS) congress shows that a combination of fluticasone propionate (fluticasone), an inhaled corticosteroid (ICS) and formoterol fumarate (formoterol), a long-acting beta2-agonist (LABA) within a single aerosol inhaler (flutiform, manufactured by Napp Pharmaceuticals) was more effective than each of the compounds administered alone on measures of lung function. It was also found to be effective in treating asthma as fluticasone and formoterol administered concurrently via separate inhalers, and had comparable efficacy in improving the lung function and a similar safety profile with budesonide/formoterol, a licensed combination asthma therapy.

Three Phase III studies for the fluticasone/formoterol combination were presented at ERS…

…the first of which measured the change in FEV1, a common measurement of the lung function, from morning pre-dose at baseline to pre-dose at week 12 seen with low-dose of the fluticasone/formoterol combination compared with formoterol. The change in FEV1 from morning pre-dose at baseline to two hours post-dose at week 12 was also compared with fluticasone in 357 adult and adolescent patients with mild to moderate asthma. This double-blind, parallel group, multicentre study, conducted in patients aged 12 and above, showed superior efficacy of the fluticasone/formoterol combination when analysed against each individual component separately on these endpoints.

The second study was an open-label, parallel group…

…European multicentre study of 210 adolescent and adult patients with mild-to-moderate-severe persistent, reversible asthma. The study demonstrated non-inferiority of the fluticasone/formoterol combination compared with the individual compounds administered concurrently based on post-dose FEV1 at week 12.

A final, double-blind, parallel group trial…

…compared the efficacy and safety of the fluticasone/formoterol combination with the budesonide/formoterol combination in 279 adolescents and adults with moderate-to-severe, persistent reversible asthma. This trial showed that the fluticasone/formoterol combination resulted in comparable improvements with the budesonide/formoterol combination in change in morning pre-dose FEV1 from baseline to week 12. The fluticasone/formoterol combination and the budesonide/formoterol combination were also shown to have similar safety profiles.

The data support previous studies, which have shown the efficacy and safety of the fluticasone/formoterol combination in adults and adolescents (aged 12 years and above). An MAA for the fluticasone/formoterol combination has been submitted to the UK Medicines and Healthcare Products Regulatory Agency (MHRA) for approval and a decision is expected later this year.

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