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 (R) 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 (R) and mometasone furoate/ indacaterol acetate and mometasone furoate/indacaterol acetate/glycopyrronium bromide formulations delivered via the Breezhaler (R). These were: (i) bridging the mometasone furoate doses in the Twisthaler (R) (previously approved) to mometasone furoate doses in the Breezhaler (R); (ii) bridging the mometasone furoate doses in the Breezhaler (R) to mometasone furoate/indacaterol acetate and mometasone furoate/indacaterol acetate/glycopyrronium bromide formulation. Following this stepwise approach, it was determined that mometasone furoate 80 mu g o.d. (medium-dose strength) and 160 mu g o.d. (high-dose strength) in mometasone furoate/indacaterol acetate/glycopyrronium bromide formulation provided comparable inhaled corticosteroid efficacy to mometasone furoate 160 mu g o.d. (medium-dose strength) and 320 mu g o.d. (high-dose strength) in the mometasone furoate/indacaterol acetate formulation, respectively. These doses were used in the PLATINUM Phase III clinical program that investigated the efficacy and safety of mometasone furoate/indacaterol acetate and mometasone furoate/indacaterol acetate/glycopyrronium bromide combinations in patients with asthma.