Mometasone furoate delivered via Breezhaler and Twisthaler in patients with asthma

Fixed-dose combination of indacaterol/glycopyrronium/mometasone furoate once-daily versus salmeterol/fluticasone twice-daily plus tiotropium once-daily in patients with uncontrolled asthma: A randomised, Phase IIIb, non-inferiority study (ARGON)

“…The primary objective was to demonstrate non-inferiority (margin of 0.25 points reduction in Asthma Quality of Life Questionnaire [AQLQ] score [17] Secondary endpoints: change from baseline in AQLQ and ACQ-7 total scores [18,19], the proportion of patients achieving the minimal clinically important difference (MCID) in AQLQ of �0.5 and ACQ-7 of �0.5 (responders) over 24 weeks, change from baseline in trough FEV 1 after 24 weeks, and change from baseline in forced vital capacity (FVC) and forced expiratory flow at 25-75% of FVC (FEF 25-75% ) over 24 weeks.…”

“…The medium (80 μg) and high (160 μg) doses of MF in the IND/GLY/ MF formulation, delivered via the Breezhaler® device, correspond to medium (400 μg) and high (800 μg) daily doses of MF, delivered via the Twisthaler® device. The corresponding doses were determined using a step-wise bridging approach, which included pharmacokinetic [16] and pharmacodynamic [17] studies and an in vitro component interaction study. Randomisation was performed using Interactive Response Technology to ensure treatment assignment was unbiased and concealed from patients and staff (supplement).…”