Science and Research

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

Indacaterol (IND; 150 mug), glycopyrronium (GLY; 50 mug) and mometasone furoate (MF; 160 mug [high-dose ICS] and 80 mug [medium-dose ICS]) have been formulated as a once-daily (o.d.) fixed-dose combination treatment delivered via the Breezhaler(R) 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 mug; 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. TRIAL REGISTRATION: ClinicalTrials.gov, (Identifier: NCT03063086), EudraCT start date: May 11, 2017; First patient first visit / study initiation date: May 31, 2017.
  • Watz, H.
  • Hohlfeld, J. M.
  • Singh, D.
  • Beier, J.
  • Diamant, Z.
  • Liu, J.
  • Hua, S.
  • Abd-Elaziz, K.
  • Pinot, P.
  • Jones, I.
  • Tillmann, H. C.

Keywords

  • Asthma
  • Glycopyrronium
  • Indacaterol
  • Mometasone Furoate
Publication details
DOI: 10.1186/s12931-020-01349-5
Journal: Respir Res
Pages: 87 
Number: 1
Work Type: Original
Location: ARCN, BREATH
Disease Area: AA
Partner / Member: Ghd, ITEM
Access-Number: 32295593
See publication on PubMed

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