Comparing a triple-medicine inhaler with a two-medicine inhaler in asthma
Compares two inhalers for asthma that is poorly controlled in adults.
Plain-language title generated from the registry record
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])
Key facts
- Where
- Badalona, Barcelona, Benalmádena, Madrid, Marbella, Sevilla, and Zaragoza, SpainSee the 9 sites
- Phase
- Phase 4
Where in Spain
- Hospital Germans Trias i PujolBadalona, SpainNot yet recruiting
- Pectus Respiratory Health S.L.Barcelona, SpainNot yet recruiting
- Hospital Vithas Xanit InternacionalBenalmádena, SpainNot yet recruiting
- Hospital Clínico San CarlosMadrid, SpainNot yet recruiting
- Hospital Universitario 12 de OctubreMadrid, SpainNot yet recruiting
- Hospital Universitario de la PrincesaMadrid, SpainNot yet recruiting
- Hospital Costa del SolMarbella, SpainNot yet recruiting
- University Hospital Virgen Del Rocio S.L.Sevilla, SpainNot yet recruiting
- Hospital Clinico Universitario Lozano BlesaZaragoza, SpainNot yet recruiting
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?
Trial details
- Who runs it
- Chiesi Farmaceutici S.p.A.
- Trial code
- NCT07666490EU 2025-524289-56-00
- Record updated
- 31 July 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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.
Exclusion: 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.