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…
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…