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

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 FEV 1 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.

Lung Function Normalisation with Indacaterol Acetate/Glycopyrronium Bromide/Mometasone Furoate in Patients with Asthma

“…Furthermore, lung function normalisation with IND/GLY/MF was complemented by a greater proportion of patients with no rescue medication use with IND/GLY/MF vs SAL/FLU and placebo. In the B2208 study, a higher percentage of patients treated with IND/GLY/MF high-dose (58%) did not require rescue medication compared with patients treated with SAL/FLU (45%) [odds ratio: 2.4; 95% confidence interval [CI] 1.7–5.0; p = 0.018]; a similar trend was also observed with IND/GLY/MF medium-dose (52%; OR: 1.7; 95% CI 0.8–3.4; p = 0.1530) vs SAL/FLU [ 7 ]. A substantial proportion of patients did not require rescue medication with either morning (67.6%; OR: 11.07; 95% CI 3.08–39.81; p = 0.0015) or evening (70.6%; OR: 11.96; 95% CI 3.45–41.39; p = 0.0016) administration of IND/GLY/MF medium-dose compared with placebo in the B2209 study.…”

“…Normal lung function was defined as FEV 1 area under the curve from 0 to 24 h [AUC (0-24h) ] ≥ 90% of predicted normal after treatment and near-normal lung function was defined as FEV 1 [AUC (0-24h) ] ≥ 80% of predicted normal after treatment. We report results from a responder analysis evaluating the percentage of patients achieving normal or near-normal lung function with IND/GLY/MF compared with salmeterol xinafoate/fluticasone propionate (SAL/FLU) or placebo from two phase II studies (CQVM149B2208 [7], NCT03063086; CQVM149B2209 [8], NCT03108027).…”

“…Patients with an asthma exacerbation requiring systemic steroids, hospitalisation or an emergency room visit within 6 weeks prior to the study were excluded. Detailed information on the study designs and patient criteria is described in the respective publications [7,8]. Patients included in the B2209 study had less severe lung function impairment with a pre-bronchodilator FEV 1 between 60 and 100% of the predicted value at screening.…”

“…Indacaterol acetate/glycopyrronium bromide/mometasone furoate (IND/GLY/MF), delivered via Breezhaler ® , is a novel once-daily treatment. The LABA/LAMA/ICS combination is approved for the maintenance treatment of asthma [ 7 ].…”

Triple Combination Inhalers in Chronic Obstructive Pulmonary Disease and Asthma

“…A phase II multi-center study compared mometasone furoate/indacaterol/ glycopyrronium bromide or QVM149 (80/150/50 μg and 160/150/50 μg) once-daily with fluticasone propionate/salmeterol (500/50 µg) twice-daily in 116 adults with asthma. 60 Overall, 107 patients completed the 3-week study. QVM149 induced a larger improvement in lung function (Δ FEV 1 : +172 mL with high-dose mometasone and +159 mL with medium-dose mometasone versus fluticasone propionate/salmeterol).…”