ERS 2020 — High-dose indacaterol/glycopyrronium/mometasone cuts asthma exacerbations vs medium-dose

  • Sarfaroj Khan
  • Conference Reports
Access to the full content of this site is available only to registered healthcare professionals. Access to the full content of this site is available only to registered healthcare professionals.


  • High-dose once-daily indacaterol acetate (IND)/glycopyrronium bromide (GLY)/mometasone furoate (MF) significantly reduced the annualized rate of moderate or severe asthma exacerbations by 21% and severe exacerbations by 31% in patients with uncontrolled asthma on current inhaled therapies vs medium-dose.
  • Both medium- and high-doses of IND/GLY/MF were well tolerated after 52 weeks of treatment.

Why this matters

  • Findings support the potential of high-dose IND/GLY/MF as an effective step-up treatment option to further reduce asthma exacerbations in patients with uncontrolled asthma.

Study design

  • IRIDIUM was a 52-week phase 3 randomized controlled trial involving 3092 patients with uncontrolled asthma.
  • Patients were randomly assigned in a 1:1:1:1:1 ratio to receive IND/GLY/MF medium-dose (150/50/80 µg), IND/GLY/MF high-dose (150/50/160 µg), IND/MF medium-dose (150/160 µg), IND/MF high-dose (150/320 µg), or salmeterol/fluticasone high-dose (50/500 µg).
  • This post hoc analysis of IRIDIUM assessed the reduction in exacerbations with IND/GLY/MF high- vs medium-dose over 52 weeks.
  • Funding: Novartis funded IRIDIUM.

Key results

  • IND/GLY/MF high-dose vs medium-dose showed clinically meaningful reductions in annualized rate of:
    • moderate or severe exacerbation (rate ratio [RR], 0.79; 95% CI, 0.64-0.97; P=.026);
    • severe exacerbation (RR, 0.69; 95% CI, 0.54-0.88; P=.003).
  • The higher dose also reduced the annualized rate of all exacerbations (mild/moderate/severe) by 14%, but this was not statistically significant (RR, 0.69; 95% CI, 0.71-1.05; P=.132).
  • The number of patients who experienced moderate or severe, severe, and all exacerbations were 30.2%, 21.8%, and 40.2%, respectively, in the IND/GLY/MF high-dose group and 32.6%, 24.5%, and 40.3%, respectively, in the IND/GLY/MF medium-dose group.
  • Both doses were well tolerated; adverse events (AEs) (incidence rate [IR], 9.2 vs 8.4 per 100 patient-year) and serious AEs (IR, 8.2 vs 8.8 per 100 patient-year) were comparable between high- and medium-dose groups.


  • Post hoc analysis.