A randomized, double-blind study to compare the efficacy and safety of two doses of mometasone furoate delivered via Breezhaler® or Twisthaler® in patients with asthma

Abstract Introduction Mometasone furoate (MF) is the inhaled corticosteroid (ICS) component in the long-acting β2-agonist (LABA)/ICS fixed-dose combination of indacaterol/MF, delivered via Breezhaler®, in development for asthma. MF at low (80 μg) and high (320 μg) doses delivered via Breezhaler® is expected to be comparable to MF at low (200 μg) and high (800 μg) doses respectively, delivered via Twisthaler®. Methods This was a randomized, double-blind, double-dummy, four-week, parallel-group study of 739 adolescents and adults with persistent asthma. Eligible patients were receiving ICS treatment up to the maximum dose per day on a stable regimen for at least four weeks before screening. T…

Corresponding doses of mometasone furoate (MF) in once-daily inhaled fixed-dose combination (FDC) of indacaterol/mometasone furoate (IND/MF) and indacaterol/glycopyrronium/mometasone furoate (IND/GLY/MF): results from randomized clinical studies

Mometasone furoate delivered via Breezhaler and Twisthaler in patients with asthma

Introduction: Mometasone furoate (MF), an inhaled corticosteroid (ICS), is approved for the treatment of asthma. Previous studies suggest that MF Twisthaler® doses of 800 and 200 µg and MF Breezhaler® doses of 320 and 80 µg would elicit similar lung function effects, respectively. These MF doses are also used in an indacaterol/MF combination in development for asthma. Since sensitivity to ICS is variable, individual patients’ ICS sensitivity (as measured by FEV1 decline on ICS weaning) was used to build a robust analysis model for the study data. Methods: This was a randomized, double-blind, double-dummy, parallel-group, non-inferiority study of 739 adolescents and adults with asthma. MF wa…

Dose bridging data for mometasone furoate in once-daily fixed-dose inhaled combinations of mometasone furoate/indacaterol and mometasone furoate/ indacaterol/glycopyrronium in patients with asthma

Once-daily (o.d.) fixed-dose combinations of mometasone furoate/indacaterol acetate (MF/IND) and mometasone furoate/indacaterol acetate/glycopyrronium bromide (MF/IND/GLY), both delivered via the Breezhaler® device, are approved for the maintenance treatment of asthma. Across these fixed-dose combinations, while the doses of bronchodilators remain the same, the nominal doses of mometasone furoate in micrograms differ. This article presents the steps followed in bridging the mometasone furoate doses at the corresponding dose strengths in the mometasone furoate formulation delivered via the Twisthaler® and mometasone furoate/indacaterol acetate and mometasone furoate/indacaterol acetate/glyco…