Change in lung function 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 LABA in combination with a medium- or high-dose ICS, and who experienced at least one asthma exacerbation in the previous year. The impact of efSITT on lung function 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 lung function in the first up to 174 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. Clinical data are collected from the patients’ medical files.

Results Mean FEV₁ at baseline was 1.96 L in the overall population, and 1.97 L in patients on prior ICS/LABA. After 6 months of treatment with efSITT the overall patient population showed an increase from baseline of 0.13 L (p=0.0002, paired t-test) in FEV₁, 0.40 L/s (p=0.0002) in PEF, 0.13 L (p=0.0011) in FVC, and a decrease of 0.30 kPa*s (p=0.0307) in sR_aw and 0.04 kPa*s/L (p=0.0176) in R_aw. The patients on prior ICS/LABA showed an increase from baseline of 0.15 L (p=0.0007) in FEV₁, 0.51 L/s (p=0.0002) in PEF, 0.14 L (p=0.0036) in FVC, and a decrease of 0.39 kPa*s (p=0.0245) in sR_aw and 0.04 kPa*s/L (p=0.0127) in R_aw. Mean change from baseline in total number of puffs of rescue medication in the previous week was -5.5 (p=0.0009) in the overall population and -5.4 (p=0.0002) in patients on prior ICS/LABA.

Conclusions This interim analysis shows a significant improvement of airflow obstruction and specific airway resistance 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