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Real-World Effectiveness and Safety of Single Inhaler Triple Therapy with Beclometasone/ Formoterol/ Glycopyrronium
Christian Gessner1,2, Richard E K Russell3, Timm Greulich4
1Pulmonary Practice/ Medical S/P/E, Leipzig, Germany.
Purpose:
To collect prospective data from asthma patients treated with medium- (87/5/9µg) or high-strength (172/5/9µg) extrafine single-inhaler beclometasone dipropionate/formoterol fumarate/glycopyrronium (BDP/FF/G, Trimbow®) in a real-world setting.
Patients And Methods:
TriMaximize is a non-interventional, prospective, multicenter study conducted in eight European countries (enrollment: 2021-2024). The primary objective was to describe patient characteristics and therapy pathways for adult patients with moderate to severe asthma treated with BDP/FF/G for up to 36 months. Assessments included demographic/clinical characteristics, pulmonary parameters, treatment pathways, asthma control measured by asthma control test (ACT), and health-related quality of life (HrQoL) measured by Mini Asthma Quality of Life Questionnaire (Mini-AQLQ).
Results:
In total, 1,445 patients (62.8% female; mean age: 57.6 years) were included. Before medium-strength BDP/FF/G initiation, 75.7% of the patients received a fixed ICS/LABA combination. Most patients starting with high-strength BDP/FF/G received fixed ICS/LABA (52.9%) or free ICS/LABA/LAMA (43.2%) combinations as prior therapy. Throughout the study, 87.1% of the patients remained on BDP/FF/G. At month 12, fewer patients (12.4%) used systemic corticosteroids (SCS) compared to baseline (33.2%). Use of rescue medication declined from 6.1 (baseline) to 3.6 puffs/week (month 12). During the first year, 79.5% of the patients experienced neither exacerbations nor used SCS. Three-component clinical remission was achieved in 45.6% (first year) and 59.3% (second/third year) of the patients. Four-component clinical remission was accomplished in 39.5% (first year) and 47.9% (second/third year). Improvements in asthma control (mean ACT change at month 12: 3.9; month 36: 4.8, p<0.0001) and HrQoL (mean Mini-AQLQ change at month 12: 0.8; month 36: 0.9, p<0.0001) exceeded the respective minimal clinically important differences. Forced expiratory volume in 1 second increased by 142 mL after 12 months (p<0.0001).
Conclusion:
Extrafine, single-inhaler BDP/FF/G therapy was effective and safe in a routine clinical practice setting in a multi-national cohort of patients with moderate to severe asthma.
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