Abstract
Background
QMF149 is an investigational inhaled fixed-dose combination of indacaterol acetate (long-acting β2-agonist) and mometasone furoate (MF, corticosteroid) delivered via the Breezhaler® device for once daily maintenance treatment of asthma and COPD. Since MF doses delivered via the Twisthaler® device are approved in asthma, bridging of MF delivered via the Twisthaler® device to MF delivered via the Breezhaler® device was necessary to ensure comparability between devices.
Objective
To demonstrate non-inferiority of MF delivered via the Breezhaler® device to MF delivered via the Twisthaler® device in trough FEV1 (tFEV1) at Week 4.
Methods
In this double-blind, parallel-group study, 739 asthma patients were randomised to receive one of four treatments (MF Breezhaler® 80 µg, MF Breezhaler® 320 µg, MF Twisthaler® 200 µg, MF Twisthaler® 800 µg) once daily for 4 weeks.
Results
In low dose comparison, LS mean difference of tFEV1 between MF 80 µg and MF 200 µg was 68 mL (p<0.001) with lower limit of 97.5% CI of 0 mL. In high dose comparison, LS mean difference of tFEV1 between MF 320 µg and MF 800 µg was 25 mL (p<0.001) with lower limit of 97.5% CI of –42.7mL. Therefore non-inferiority of MF Breezhaler® to MF Twisthaler® for both low and high doses was demonstrated as lower limit of one-sided 97.5% CI was above pre-defined non-inferiority margin of –90 mL. Mean plasma MF AUC and Cmax were lower for the Breezhaler® doses vs the corresponding Twisthaler® doses. All treatments showed good safety profile.
Conclusion
This study confirms that selected MF doses of 80 µg and 320 µg delivered via the Breezhaler® device are comparable to MF doses of 200 µg and 800 µg delivered via the Twisthaler® device in asthma.
- © 2014 ERS
