Mometasone furoate delivered via the Breezhaler ® and Twisthaler ® devices in asthma

Background QMF149 is an investigational inhaled fixed-dose combination of indacaterol acetate (long-acting β 2 -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 FEV 1 (tFEV 1 ) 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 tFEV 1 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 tFEV 1 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.