Fluticasone propionate/formoterol: Phase III data

A double-blind Phase III trial in 512 patients with asthma ages >=5 and <12 showed that twice-daily flutiform met the co-primary endpoints of superiority to fluticasone propionate (treatment difference of 0.07 L, p<0.001) and non-inferiority to salmeterol/fluticasone propionate (no treatment difference, p<0.001 for non-inferiority) in the change in pre-dose FEV1 at baseline to 2 hours post-dose over 12 weeks. Data were presented at the European Respiratory Society meeting in Munich. Mundipharma declined to provide details on regulatory plans for flutiform in the pediatric asthma indication. ...