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P298 Time course of exacerbation reduction with extrafine beclomethasone dipropionate, formoterol fumarate, and glycopyrronium bromide (BDP/FF/GB) pMDI in adults with moderate to severe asthma: a post-hoc analysis of the TRIMARAN and TRIGGER studies

thoraxjnl · 2025-11-02 · canonical JSON source

22 visible annotations · policy: published · automated confidence ≥ 75.00%

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Rationale Patients with asthma uncontrolled by medium to high dose ICS/LABA (GINA Steps 4 and 5) may benefit from the addition of a LAMA. The time to achieve a reduction in severe exacerbations is not well understood. TRIMARAN (Triple versus medium strength of ICS/LABA) and TRIGGER (Triple versus high strength ICS/LABA) studies tested the efficacy of extrafine BDP/FF/GB combination vs BDP/FF combination containing medium to high BDP dose.Methods We conducted a post-hoc analysis of the TRIMARAN and TRIGGER studies [Virchow JC et al, Lancet 2019] in patients with asthma to assess the frequency of severe exacerbations every 4 months to 12-months. A generalised linear mixed model for repeated measures considering a Poisson distribution was used.Results A total of 1149 and 1142 subjects in TRIMARAN and TRIGGER, respectively received BDP/FF/GB or BDP/FF. A reduction in severe exacerbations of 16.3% and 10.7% with BDP/FF/GB vs BDP/FF was observed in the first 4 months in TRIMARAN and TRIGGER, respectively (adjusted rate ratio [RR] of 0.837, 95% CI 0.572–1.231, p=0.3682 and RR of 0.893 95% CI 0.634–1.257, p=0.5148). The reduction in the subsequent 8 months (period 4–12 months) was of 30.5% and 24.1%, in TRIMARAN and TRIGGER, respectively (RR of 0.695, 95% CI 0.501–0.965, p=0.0296 and of 0.759, 95% CI 0.565–1.019, p=0.0663).Abstract P298 Figure 1Conclusions A clinically relevant reduction in the number of severe asthma exacerbations can be seen as early as 4 months following step-up therapy to BDP/FF/GB. This reduction was progressive and sustained over the remainder of the 12-month treatment.