Taking peoplePhase 4
Comparing a triple-medicine inhaler with a two-medicine inhaler in asthma
Compares two inhalers for asthma that is poorly controlled in adults.
Key facts
- Who runs it
- Chiesi Farmaceutici S.p.A.
- Where
- Battipaglia, Ferrara, Florence, Foggia, Genoa, and Rome, ItalySee the 6 sitesAlso in 8 other countries, 83 sites
- Trial code
- Registry title
- BETRI-Prospective: Asthma Control in Single Inhaler ICS/LABA/LAMA (87/5/9 pMDI [BDP/FF/GB - 100/6/12.5 μg]) vs Single Inhaler ICS/LABA (200/6 pMDI [BDP/FF - 200/6 μg])
- Status
- Recruiting
- Phase
- Phase 4
- People taking part
- 644 people, planned
- Started
- 28 Jun 2026
- Expected to end
- 13 Jun 2028
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Beclometasone dipropionate, formoterol fumarate, and glycopyrronium bromide (100/6/12.5 µg per actuation)
- Foster® 200/6 pMDI (BDP/FF-200/6 µg)
- Record updated
- 31 July 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with asthma that is poorly controlled despite regular medium-strength ICS/LABA treatment. It compares a triple inhaler with a two-drug inhaler.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Doctor-confirmed asthma, poorly controlled: ACQ-5 of 1.5 or more and at least 1 exacerbation in the previous year. No clinically relevant COPD.
- Earlier treatment
- At least 3 months on regular medium-strength ICS/LABA treatment. People on MART can join if the ICS dose does not exceed 400 µg/day of beclometasone or equivalent.
Main reasons for not taking part
- Taking part in another interventional clinical trial
- Pregnant or breastfeeding at enrolment
- Other chronic lung disease, such as lung cancer, tuberculosis, interstitial lung disease or pulmonary hypertension
- Contraindication for LAMA use
- Taking biological therapies for asthma
The registry criteria, word for word
Show all 12 criteriaShow less
Who can take part
- 1 . Study participant's written informed consent obtained prior to any study related procedure
- Male or female study participants aged ≥18 years old. 3. Physician confirmed documented asthma diagnosis as per current clinical practice
- Stable asthma treatment prior randomisation: At least 3 months on any medium strength (MS) ICS/LABA regular treatment
- Poor asthma control at randomisation (ACQ-5 ≥1.5 and at least 1 exacerbation in the previous year)
- Women with childbearing potential (WOCBP) and with fertile male partners: they and/or their partner must be willing to use a highly effective birth control method from the signature of the informed consent and until the last visit
- Study participants must have a cooperative attitude and the ability to be trained to use the patient app correctly, to be able to perform the required outcomes measurements (e.g. ePRO completion) and the ability to understand the risks involved; Note: Study participants with asthma diagnosis and no clinically relevant concurrent COPD diagnosis upon clinical judgement can be included. Study participants on maintenance and reliever therapy (MART) can be included if the ICS dosage does not exceed 400 µg/day of beclometasone or equivalent
Who cannot take part
- Study participants on biological therapies for asthma
- Other chronic respiratory disease: Lung Cancer, known alpha1-antitrypsin deficiency, active tuberculosis, clinically significant bronchiectasis, interstitial lung disease, pulmonary hypertension, or any other uncontrolled/clinically significant diseases (according to investigator's judgement)
- Participation in another interventional clinical trial
- Pregnant or breastfeeding women at the moment of enrolment
- Contraindication for LAMA use
- For France only: Individuals under court protection (including protected adults) and individuals not affiliated to a social security system are excluded from participation in this study (Country/Region-Specific Differences - France), in accordance with Articles L.1121-6, L.1121-8, and L.1121-8-1 of the French Public Health Code
Where in Italy
Also in 8 other countries, 83 sites
- Azienda Sanitaria Locale Di SalernoBattipaglia, ItalyNot yet recruiting
- University Hospital Of FerraraFerrara, ItalyNot yet recruiting
- Azienda Ospedaliero-Universitaria CareggiFlorence, ItalyNot yet recruiting
- Azienda Ospedaliero Universitaria Ospedali RiunitiFoggia, ItalyNot yet recruiting
- IRCCS Ospedale Policlinico San MartinoGenoa, ItalyNot yet recruiting
- Ospedale Isola Tiberina - Gemelli IsolaRome, ItalyNot yet recruiting
About the trial
What the trial wants to find out
This study will evaluate the effect of triple ICS/LAMA/LABA therapy with a BDP/FF/GB 100/6/12.5 µg on asthma control outcomes relative to ICS/LABA therapy with BDP/FF 200/6 μg in a population with asthma poorly controlled.
The 2 groups in the trial
- BDP/FF/GBExisting treatment, for comparison
Trimbow® 87/5/9 pMDI (BDP/FF/GB 100/6/12.5 µg) - 2 inhalations bid
Treatment: Beclometasone dipropionate, formoterol fumarate, and glycopyrronium bromide (100/6/12.5 µg per actuation)
- BDP/FFExisting treatment, for comparison
Foster® 200/6 pMDI (BDP/FF 200/6 µg) - 2 inhalations bid
Treatment: Foster® 200/6 pMDI (BDP/FF-200/6 µg)
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- Official 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
- Plain-language title
- Comparing a triple-medicine inhaler with a two-medicine inhaler in asthmaGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 31 July 2026