- 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.
- 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.
- 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.