Achieving clinical remission in moderate-to-severe asthma using inhaled triple therapy.

Abstract

Background: There is growing interest in evaluating the ability of treatments to deliver clinical remission in patients with asthma. We conducted post hoc analyses of TRIMARAN and TRIGGER, two clinical studies comparing the efficacy and safety of fixed-dose combination beclometasone dipropionate (BDP), formoterol fumarate (FF) and glycopyrronium (G) (TRIMARAN, 100/6/10 μg and TRIGGER 200/6/10 µg) with BDP/FF (100/6 µg and 200/6 µg, respectively).

Methods: Clinical remission was defined as: no use of oral corticosteroids over 52 weeks, no occurrence of severe exacerbations over 52 weeks, Asthma Control Questionnaire-5 score <1.5 at weeks 26, 40 and 52, and pre-dose forced expiratory volume in 1 s at week 52 equal to, or higher than, the baseline value.

Results: Of 2291 patients included in these analyses, 598 (26.1%) met the clinical remission definition (i.e. met all criteria) at week 52: 315 (27.4%) in TRIMARAN and 283 (24.8%) in TRIGGER. The proportion of patients who achieved clinical remission was higher in the BDP/FF/G group than in the BDP/FF group in both studies (29.4% and 29.6% in TRIMARAN and TRIGGER, respectively, versus 25.4% and 20.0%), with the difference reaching statistical significance in TRIGGER (odds ratio 1.70, 95% confidence interval 1.29-2.23; p<0.001) and when data were pooled (29.5% versus 22.7%; 1.44, 1.19-1.73; p<0.001).

Conclusions: Among patients with asthma that was uncontrolled by an inhaled corticosteroid (ICS)/long-acting β₂-agonist (LABA) combination prior to study entry, a higher proportion achieved clinical remission by switching to inhaled triple therapy than by continuing ICS/LABA.