Exacerbation reduction and improved quality of life in asthma with extrafine formulation single-inhaler triple therapy (efSITT): six-month results of the TriMaximize Study

<bold>Background:</bold> The efficacy of efSITT consisting of beclometasone dipropionate/formoterol fumarate/glycopyrronium bromide has been confirmed in clinical trials. Study populations included uncontrolled asthma patients on medium- or high-dose inhaled corticosteroid and long-acting beta2-agonist (ICS/LABA) experiencing at least one exacerbation in the previous year. However, the impact of efSITT on exacerbations and health-related quality of life (HRQoL) in asthma patients remains to be assessed in a real-world setting. <bold>Methods:</bold> This non-interventional study observes asthma patients for one to three years after being prescribed efSITT. Descriptive analyses of HRQoL evaluated by Mini Asthma Quality of Life Questionnaire (Mini AQLQ) and exacerbation rates were performed. <bold>Results:</bold> This interim analysis includes 1090 (63.3% female) patients, majority (75.3%) previously treated with ICS/LABA (open or fixed). All included patients had at least one exacerbation in the last year (60% one, 38 % two or more, 2% missing entries). Only moderate exacerbations were observed in 72.9%, only severe in 14.4%, both moderate and severe in 10.6% and mild or unknown in 2.0% with a mean exacerbation rate of 1.8/year. Mean Mini AQLQ score at baseline was 4.2 points. After 6 months of treatment exacerbation rate decreased by 1.7 (p<0.0001). The mean change in Mini AQLQ score from baseline was 0.8 points (p<0.0001), exceeding the minimal clinically important difference of 0.5 points. <bold>Conclusions:</bold> Exacerbation reductions and improvement in HRQoL were observed six months after switching to efSITT from dual as well as free triple combinations.