BETRI-Prospective
Research type
Research Study
Full title
A pragmatic, phase IV, randomized, open-label, multinational, multicentre, 2-arm parallel group, prospective study comparing efficacy and safety of Single Inhaler ICS/LABA/LAMA (beclometasone/formoterol fumarate/glycopyrronium bromide [87/5/9 pMDI {BD/FF/GB - 100/6/12.5 µg}]) vs Single Inhaler ICS/LABA (beclometasone dipropionate plus formoterol fumarate [200/6 pMDI {BD/FF - 200/6 µg]) in asthma subjects
IRAS ID
1013422
Contact name
Germano Lucci
Contact email
Sponsor organisation
Chiesi Farmaceutici S.p.A.
Eudract number
0000-000000-00
Research summary
Chiesi Farmaceutici S.p.A. is running this research study to see if the study drugs help people with asthma in similar ways and to check how safe they are. The study drugs tested in this study are as follows:
Trimbow® (Single Inhaler Triple Therapy): 87/5/9 pressurized metered-dose inhaler (pMDI) containing beclometasone dipropionate/formoterol fumarate/glycopyrronium bromide (BD/FF/GB – 100/6/12.5 µg per actuation); administered as 2 inhalations twice daily.
Foster® (Single Inhaler Double Therapy): 200/6 pMDI containing beclometasone dipropionate/formoterol fumarate (BD/FF – 200/6 µg per actuation); administered as 2 inhalations twice daily.
Trimbow® and Foster® are approved medicines in Europe for treating asthma and they are both made by Chiesi Farmaceutici.
Main objective: to look at whether Trimbow® can help uncontrolled asthmatics to improve symptoms control and be alternative to higher doses of inhaled corticosteroids to feel better, breathe easier, and avoid needing higher doses of corticosteroids - a medicine which can cause side effects if used too much.
Secondary objectives: to check how safe and well-tolerated Trimbow® is over 12 time compared to Foster®. Look at how Trimbow® affects other aspects of lung function, asthma flare-ups, participants’ overall health, and other key clinical results
Participation in this research study will involve 7 visits and will last about 12 months.
This study will include up to about 644 men and women with asthma. Participants will be adults (> 18 years old) when they join this study.
Each participant will be randomly assigned to one of two groups: half will receive Trimbow®, and the other half will receive Foster® This will be open-label study, which means that both the participants and study staff will know what treatments the participants receive.
Participants will receive either Trimbow® or Foster® twice a day for 12 months.
Study staff will check participants’ overall health throughout the study.REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
26/EM/0013
Date of REC Opinion
17 Apr 2026
REC opinion
Further Information Favourable Opinion