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February 22, 2026Open Access

Real-World Effectiveness and Safety of Single Inhaler Triple Therapy with Beclometasone/ Formoterol/ Glycopyrronium in Moderate to Severe Asthma: TriMaximize Study

Puntos clave

The study aims to assess the real-world effectiveness and safety of single inhaler triple therapy in adults with moderate to severe asthma.
Multicenter, non-interventional study across eight European countries.
Data collected on patient characteristics, treatment pathways, and clinical assessments.
Followed patients on beclometasone/formoterol/glycopyrronium therapy for up to 36 months.
87.1% of patients continued BDP/FF/G therapy over the study period.
Significant reductions in systemic corticosteroid use and rescue medication were observed.
Improved asthma control and quality of life metrics exceeded minimal clinically important differences.
Forced expiratory volume increased significantly after 12 months.

Resumen

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. Keywords: airways disease, exacerbations, health related quality of life, lung function, remission, treatment pathways

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