Abstract

Background: Extrafine formulation single-inhaler triple therapy (efSITT) consisting of beclometasone dipropionate/formoterol fumarate/glycopyrronium has shown major therapeutic benefits in clinical trials. The impact of efSITT on health-related quality of life (HRQoL) in patients with asthma under real-life conditions remains to be assessed. Aims and objectives: The TriMaximize study aims to provide the characteristics, therapy pathways and health-related outcomes of patients with moderate-to-severe asthma prescribed efSITT in real-world practice. We present an interim analysis of the changes in HRQoL in the first 280 patients from Germany, United Kingdom, Austria and Denmark after three months of treatment with efSITT. Methods: This is a multicenter, multinational, prospective, observational study investigating the impact of efSITT in patients with moderate-to-severe asthma prescribed efSITT for 1?3 years in real-world practice. Changes in HRQoL are measured using the Mini Asthma Quality of Life Questionnaire (Mini AQLQ). Results: The majority (78%) of patients were on prior ICS/LABA treatment, and 22% on prior ICS/LABA/LAMA. Mean Mini AQLQ score at baseline was 4.1 points. After three months of treatment with efSITT, mean change from baseline in Mini AQLQ score was 0.7 points in the overall population, and 0.9 points in patients on prior ICS/LABA (all p<0.0001). Both results exceeded the MCID of 0.5 points. Conclusions: Our data show a significant improvement in HRQoL in patients with moderate-to-severe asthma after three months of treatment with efSITT following a switch from ICS/LABA or ICS/LABA/LAMA.