Study FLT-3501 assessed 182 patients, suffering from mild to
moderate-severe persistent and reversible asthma, who were treated in accordance with the protocol. This randomized, open label, parallel group study compared Flutiform pMDI (100mcg fluticasone & 10mcg formoterol bid, or 250/10mcg bid, respectively) to Seretide pMDI (100mcg fluticasone & 50mcg salmeterol bid, or 250/50mcg bid, respectively), with the goal to demonstrate comparable efficacy between treatment arms. Enrolled patients had to have a disease history of at least six months and were treated for 12 weeks.
Mean pre-dose FEV1 (Forced Expiratory Volume in the first second) was the primary parameter measured and the top line analysis shows that this end point was successfully met. The statistical analysis shows that, in both treatment groups, there was an improvement in lung function from the baseline measurement (using FEV1) whilst the performance of Flutiform was not statistically inferior to that of Seretide.
Study FLT-3505 analyzed 196 adult and adolescent patients, suffering from mild to moderate-severe persistent and reversible asthma, who were treated in accordance with the protocol. This randomized, open label, parallel group study compared Flutiform pMDI (100mcg fluticasone & 10mcg formoterol bid, or 250/ 10mcg bid, respectively) to its individual components, fluticasone and formoterol, administered concurrently with the goal to demonstrate non-inferiority of Flutiform to the other treatment arm based on FEV1.
Enrolled patients were again treated for 12 weeks. The top line statistical analysis of the primary parameter confirms that Flutiform is not inferior compared with the concurrent administration of fluticasone and formoterol.
Ken Cunningham, SkyePharma’s COO, said: “We are delighted that along with the three Phase III pivotal efficacy studies conducted for NDA submission, we now have two further Phase III studies for European regulatory submission that have met their primary endpoints.”