Improvement in lung function after six months of treatment with extrafine formulation single-inhaler triple therapy (efSITT) in patients with asthma-TriMaximize Study

<bold>Background:</bold> Clinical trials have demonstrated the efficacy of efSITT consisting of beclometasone dipropionate/formoterol fumarate/glycopyrronium bromide (BDP/FF/G) on lung function in asthma patients. The effects in a real-life setting have yet to be evaluated. <bold>Methods:</bold> This real-world study observes patients with asthma over a period of one to three years after being prescribed efSITT. Pre-bronchodilator lung function was assessed by spirometry and body plethysmography. <bold>Results:</bold> This interim analysis includes 1090 patients (age 58, 63.3 % female). Mean FEV₁ at baseline was 67.08 % of predicted in the overall population, and 67.73 % of predicted in patients on prior ICS/LABA (open or fixed, n=587). Six months after switching to efSITT the overall population showed an increase from baseline of 3.95 percentage points (%pt) in % of predicted FEV₁ (p<0.0001), 0.35 L/s in PEF (p<0.0001), 3.81 %pt in FVC (p<0.0001), and a decrease of 19.31 %pt in sRtot (p<0.0163) and 7.79 %pt in RV/TLC (p<0.0017). Patients on prior ICS/LABA showed an increase of 4.09 %pt in FEV₁ (p<0.0001), 0.44 L/s in PEF (p<0.0001), 4.51 %pt in FVC (p<0.0001), and a decrease of 28.08 %pt in sRtot (p<0.0011) and 9.07 %pt in RV/TLC (p<0.0007). Total use of rescue medication decreased by 5.0 puffs/week in the overall population and by 4.5 puffs/week in patients on prior ICS/LABA (both p<0.0001). <bold>Conclusions:</bold> Significant lung function improvement and reduction in rescue medication use were observed in asthma patients six months after switching to efSITT. This especially includes parameters of peripheral obstruction (sRtot) and hyperinflation (RV/TLC).