Background: Clinical trials have shown significant therapeutic benefits of extrafine formulation single-inhaler triple therapy (efSITT) consisting of beclometasone dipropionate/formoterol fumarate/glycopyrronium in the treatment of patients with asthma. The impact of efSITT on lung function in patients with asthma in a real-life setting is yet 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 lung function in the first 284 patients from Germany, United Kingdom, Austria, and Denmark after three months of treatment with efSITT. Methods: This is a multicenter, multinational, prospective, observational study following patients with asthma for 1?3 years. Clinical data are collected from patients? medical records. Results: The majority (79.7%) of patients were on prior ICS/LABA treatment, and 20.3% on prior ICS/LABA/LAMA.
Overall | Prior ICS/LABA | Prior ICS/LABA/LAMA | |
Mean FEV1 at baseline | 1.93 L | 1.94 L | 1.89 L |
Mean change from baseline at 3 months | Overall | Prior ICS/LABA | Prior ICS/LABA/LAMA |
FEV1, mL |
141 p<0.0001 |
154 p<0.0001 |
90 p=0.0328 |
PEF, mL/s |
245 p=0.0004 |
264 p=0.0022 |
186 p=0.0534 |
FVC, mL |
178 p<0.0001 |
180 p<0.0001 |
173 p=0.0036 |
sRaw, kPa*s |
-0.25 p=0.0048 |
-0.27 p=0.0065 |
-0.14 p=0.4288 |
Conclusions: Our data show a significant improvement in lung function and specific airway resistance in patients with moderate-to-severe asthma after three months of treatment with efSITT following a switch from ICS/LABA or ICS/LABA/LAMA.