Abstract

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.