Change in asthma control after 6 months of treatment with extrafine single-inhaler triple therapy in asthmatics: a real-world view from Germany

Background Randomized controlled trials have shown significant clinical benefits of extrafine single-inhaler triple therapy (efSITT) consisting of extrafine beclomethasone dipropionate/formoterol fumarate/glycopyrronium bromide (BDP/FF/G; 87/5/9 µg) in the treatment of patients with asthma not adequately controlled on a long-acting beta-2-agonist in combination with a medium- or high-dose inhaled corticosteroid, and who experienced at least one asthma exacerbation in the previous year. The impact of efSITT on asthma control in a real-world setting is yet to be evaluated.

Aims The TriMaximize study aims to provide a real-world view of the characteristics and therapy pathways in patients with moderate to severe asthma prescribed efSITT in real-world practice, and to characterize the effects of efSITT on health-related outcomes. Here, we present an interim analysis of the changes in asthma control in the first 199 patients from Germany after 6 months of treatment with efSITT.

Methods This is a multicenter multicountry prospective non-interventional study aiming to observe asthmatics prescribed efSITT, two inhalations twice daily, for 12 to 36 months in a real-world practice. Changes in asthma control are measured by the Asthma Control Test (ACT).

Results The majority (75.4%) were on prior ICS/LABA treatment, and 24.6% on prior ICS/LABA/LAMA. Mean ACT score at baseline was 14.6 points. After 6 months of treatment with efSITT, mean change from baseline in ACT score was 3.7 points (p<0.0001, paired t-test) in the overall population and 4.4 points (p<0.0001, paired t-test) in patients on prior ICS/LABA, with both results exceeding the minimal clinically important difference (MCID) of 3 points. 57.3% of the patients reached the MCID for ACT (63.3% in patients on prior ICS/LABA, 38.8% in patients on prior ICS/LABA/LAMA; p=0.0263, chi-squared test). 62% of the patients with uncontrolled or partly controlled asthma at baseline improved to a higher asthma control status (p=0.0003, chi-squared test).

Conclusions This interim analysis shows a significant improvement of asthma control in patients with moderate to severe asthma after 6 months of treatment with efSITT with BDP/FF/G (87/5/9 µg) following a switch from ICS/LABA or ICS/LABA/LAMA.

Publication History

Article published online:
09 March 2023