Letter to the editor: Indacaterol/glycopyrronium/mometasone furoate compared with salmeterol/fluticasone propionate in patients with asthma: A randomized controlled cross-over study

Research output: Contribution to journalArticle

Abstract

Indacaterol (IND; 150 μg), glycopyrronium (GLY; 50 μg) and mometasone furoate (MF; 160 μg [high-dose ICS] and 80 μg [medium-dose ICS]) have been formulated as a once-daily (o.d.) fixed-dose combination treatment delivered via the Breezhaler® device for the treatment of patients with asthma. In this randomized (n = 116), double-blind, double-dummy, active comparator-controlled, three-period cross-over study we evaluated the benefit of o.d. IND/GLY/MF versus twice daily (b.i.d.) salmeterol/fluticasone propionate combination (SFC; 50/500 μg; high-dose ICS) treatment (NCT03063086). Overall, 107 patients completed the study. The study met its primary objective by demonstrating superiority of o.d. IND/GLY/MF at medium and high-dose ICS over b.i.d. SFC (high-dose ICS) in peak FEV1 after 21 days of treatment (+ 172 mL with high-dose and + 159 mL with medium-dose IND/GLY/MF versus SFC, p < 0.0001 for each comparison). We also observed that a higher percentage of patients did not need rescue medicine with IND/GLY/MF (high-dose ICS, 58%; medium-dose ICS, 52%) compared with SFC (45%) during the last week of each treatment period. Study treatments were well-tolerated with no relevant differences in tolerability between both IND/GLY/MF doses and SFC. In conclusion, both doses of IND/GLY/MF provided superior lung function benefits compared with twice-daily, standard-of-care SFC at the highest approved dose.

Details

Authors
  • Henrik Watz
  • Jens M. Hohlfeld
  • Dave Singh
  • Jutta Beier
  • Zuzana Diamant
  • Jinming Liu
  • Shucheng Hua
  • Khalid Abd-Elaziz
  • Pascale Pinot
  • Ieuan Jones
  • Hanns Christian Tillmann
Organisations
External organisations
  • Fraunhofer Institute for Toxicology and Experimental Medicine
  • University of Manchester
  • Institut für Atemwegsforschung GmbH
  • Skåne University Hospital
  • QPS-Netherlands
  • German Center for Lung Research (DZL)
  • LungenClinic Grosshansdorf
  • Hannover Medical School
  • Central Manchester University Hospitals
  • Shanghai Pulmonary Hospital
  • The First Bethune Hospital of Jilin University
  • Novartis Pharma AG
Research areas and keywords

Subject classification (UKÄ) – MANDATORY

  • Respiratory Medicine and Allergy
  • Pharmacology and Toxicology

Keywords

  • Asthma, Glycopyrronium, Indacaterol, Mometasone Furoate
Original languageEnglish
Article number87
JournalRespiratory Research
Volume21
Issue number1
Publication statusPublished - 2020 Apr 15
Publication categoryResearch
Peer-reviewedYes