S27 Effect of high ICS dose fixed combination extrafine beclomethasone dipropionate, formoterol fumarate, and glycopyrronium (BDP/FF/G) pMDI on asthma control in patients with persistent airflow limitation (PAL): a post-hoc analysis of the TRIGGER study

Abstract

<h3>Introduction and Objectives</h3> Persistent airflow limitation (PAL) predicts a positive clinical response to add-on long acting muscarinic antagonist in patients with asthma taking inhaled corticosteroids and long-acting β2-receptor agonists. We conducted a <i>post-hoc</i> analysis of the TRIGGER study to evaluate the effect of extrafine BDP/FF/G vs BDP/FF on asthma control and the use of systemic corticosteroids for asthma exacerbations in a subset of patients with PAL. <h3>Methods</h3> TRIGGER was a phase III, randomized, parallel group trial comparing 52-week treatment with BDP/FF/G 200/6/10µg two inhalations twice daily (BID) to BDP/FF 200/6µg BID and an open-label treatment arm consisting of BDP/FF 200/6µg BID plus tiotropium (BDP/FF+Tio). PAL criteria were a post-bronchodilator FEV₁≤80% of predicted normal and FEV₁/FVC≤0.7; ACQ-7 response was defined as a change from baseline in ACQ-7 score ≤-0.5 unit, and asthma control days as asthma symptom-free day without using rescue medication. <h3>Results</h3> 1437 subjects were randomized and 61.2% met the PAL criteria. In this subgroup, there was a significantly higher percentage of ACQ-7 responders on BDP/FF/G compared to BDP/FF at week 26 (60.2% vs 49.4%) and week 52 (60.8% vs 51.7%). In the overall population, the difference in the percentage of ACQ-7 responders was 61.3% vs 55.9% at week 26 and 62.3% vs 58.1% at week 52, for BDP/FF/G and BDP/FF respectively. In patients with PAL, the change from baseline in the asthma control days over 52 weeks was higher in BDP/FF/G compared to BDP/FF (14.5% vs 8.8%), with a smaller difference observed in the overall population (Table 1). Patients treated with BDP/FF/G had less days of systemic corticosteroid use for asthma exacerbations compared to BDP/FF in the PAL subpopulation (34.1% reduction; RR=0.659, 95%CI (0.389–1.118) p=0.122), and in the overall population (24.4% reduction; RR=0.756, 95%CI (0.499–1.145) p=0.186), although not statistically significant. <h3>Conclusions</h3> In adult asthmatics with PAL, treatment with high ICS dose extrafine BDP/FF/G compared to BDP/FF was associated with greater odds of experiencing asthma control and a higher trend towards a decreased use of systemic corticosteroids for asthma exacerbations, compared to the overall population.