Abstract
Introduction: Previously we have reported that treatment with extrafine beclometasone dipropionate/formoterol fumarate/glycopyrronium bromide (BDP/FF/GB) compared to BDP/FF (TRIMARAN and TRIGGER studies) significantly reduced the annual rate of severe asthma exacerbations by 23% (p=0.008) in patients with uncontrolled asthma on ICS/LABA and history of exacerbation in the past year.
Objectives: We conducted a stratified analysis of the pooled data sets to identify variables associated with the most prominent response to triple therapy.
Methods: TRIMARAN and TRIGGER were two phase III randomized, multicentre, parallel group trials comparing 52-week treatment with medium strength BDP/FF/GB 400/24/50 µg/d to BDP/FF 400/24 µg/d (TRIMARAN) and high strength BDP/FF/GB 800/24/50 µg/d to BDP/FF 800/24 µg/d (TRIGGER).
Results: 1146 patients on BDP/FF/GB and 1145 on BDP/FF were considered for this pre-specified pooled analysis. Statistically significant (p < 0.024) differences in adjusted rate ratios (RR) favouring BDP/FF/GB were observed in the following subgroups: Patients with a BMI < 25 kg/m2 (0.570), males (0.651), 1 exacerbation in the previous year (0.731), non-smokers (0.764), age < 65 years (0.770), and reversibility > 400 mL following salbutamol 400 µg (0.729).
Conclusions: Triple therapy with extrafine BDP/FF/GB significantly reduces severe exacerbations in asthmatics uncontrolled on ICS/LABA. Six easily identifiable traits are associated with the most prominent response to treatment and may help treatment escalation decision at the point of care.
Footnotes
Cite this article as: European Respiratory Journal 2019; 54: Suppl. 63, RCT3779.
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- Copyright ©the authors 2019