Low-dose indacaterol/mometasone improves FEV1 in adolescents, adults with asthma

The use of low-dose indacaterol acetate/mometasone furoate (IND/MF), a long-acting β2-agonist/inhaled corticosteroid (LABA/ICS) combination, significantly improves trough FEV₁* in symptomatic patients with poorly controlled asthma, according to the QUARTZ** study presented at ERS 2019.

This phase III, multicentre, double-blind, double-dummy, parallel-group trial involved 64 adolescents and 738 adults (aged ≥12 and ≤75 years) with inadequately controlled asthma who were taking low-dose ICS, with or without LABA, for ≥1 month. They were randomized 1:1 to receive either IND/MF (150/80 μg; n=398) or MF alone (200 μg; n=404) once daily for 12 weeks. [ERS 2019, abstract RCT3780]

At 12 weeks, patients treated with IND/MF had a significantly greater improvement from baseline in trough FEV₁ compared with MF alone (0.234 vs 0.051 L; mean difference, 0.182 L, 95 percent confidence interval [CI], 0.148–0.217; p<0.001).

Patients on IND/MF also reported significant improvement from baseline in asthma control, as shown by Asthma Control Questionnaire (ACQ)-7 score, than those on MF alone at 12 weeks (-0.947 vs -0.730; mean difference, -0.218, 95 percent CI, -0.293 to -0.143; p<0.001).

In a responder analysis, more patients on IND/MF achieved an improvement of ≥0.5 units in the ACQ-7 score after 12 weeks compared with those on MF alone (74.7 percent vs 64.9 percent; odds ratio, 1.69, 95 percent CI, 1.23–2.33).

Adverse events (AEs) occurred at a lower rate in the IND/MF arm (32.3 percent vs 38.3 percent), while serious AEs occurred at a comparable rate between the IND/MF and MF arms (1.3 percent vs 1.8 percent).

“GINA*** 2019 recommends the addition of LABA to ICS monotherapy as the maintenance controller therapy in patients with inadequately controlled asthma. The combination helps in achieving asthma control [in terms of ACQ-7 score] by reducing symptoms and improving lung function [in terms of trough FEV₁ score] in these patients,” said Dr Peter Andrea from Novartis Pharmaceuticals Corporation at East Hanover in New Jersey, US.

“To our knowledge, this is the first study to compare a low-dose ICS/LABA fixed-dose combination once-daily to low-dose ICS monotherapy in adult and adolescent patients with inadequately controlled asthma, … [and] this study provided evidence for benefits across a range of lung function and symptomatic endpoints,” Andrea said.

“Overall, results support the use of IND/MF 150/80 µg once-daily as a potential treatment in adult and adolescent patients with asthma inadequately controlled on low-dose ICS (+/- controller),” he concluded.

*FEV₁: Forced expiratory volume in 1 second

**QUARTZ: Study of QMF149 (150/80 µg) compared with MF Twisthaler^® (200 µg) in patients with asthma