NCT07666490RecruitingPhase 4
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])
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
Source: ClinicalTrials.gov · Last updated 31 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 644 (estimated)
- First submitted
- 21 May 2026
- Start date
- 28 Jun 2026
- Primary completion date
- 13 Jun 2028
- Lead sponsor
- Chiesi Farmaceutici S.p.A.
- Diseases
- Asthma
- NCT number
- NCT07666490
- EU CT number
- 2025-524289-56-00
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 644
- From 28 Jun 2026 to the primary completion date, 13 Jun 2028
- 89 sites in 9 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Study participants on biological therapies for asthma.
Other illness
- 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).
Other
- 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.
Who the study is looking for
- 1 . Study participant's written informed consent obtained prior to any study related procedure.
- 2\. Male or female study participants aged ≥18 years old. 3. Physician confirmed documented asthma diagnosis as per current clinical practice.
- 4\. Stable asthma treatment prior randomisation: At least 3 months on any medium strength (MS) ICS/LABA regular treatment.
- 5\. Poor asthma control at randomisation (ACQ-5 ≥1.5 and at least 1 exacerbation in the previous year).
- 6\. 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.
- 7\. 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (89)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Asclepius Medical Center OOD Coordinator of this site? Confirm its status | Dupnitsa | Bulgaria | Not yet recruiting |
| Multiprofile Hospital For Active Treatment "Dr. Tota Venkova" AD Coordinator of this site? Confirm its status | Gabrovo | Bulgaria | Not yet recruiting |
| Medical Center Pulmo - 2018 EOOD Coordinator of this site? Confirm its status | Haskovo | Bulgaria | Not yet recruiting |
| Medical Center Zdrave-1 OOD Coordinator of this site? Confirm its status | Kozloduy | Bulgaria | Not yet recruiting |
| University Multiprofile Hospital for Active Treatment Dr Georgi Stranski EAD Coordinator of this site? Confirm its status | Pleven | Bulgaria | Not yet recruiting |
| Medical Center FAMA Medical Ltd. Coordinator of this site? Confirm its status | Plovdiv | Bulgaria | Not yet recruiting |
| Ambulatoria Za Individualna Praktika Za Specializirana Izvunbolnichna Medicinska Pomost Po Alergologia Doktor Talyat Sali Cholak EOOD Coordinator of this site? Confirm its status | Razgrad | Bulgaria | Not yet recruiting |
| MC Re Spiro OOD Coordinator of this site? Confirm its status | Razgrad | Bulgaria | Not yet recruiting |
| Medical Center Hermes Ruse Ltd. Coordinator of this site? Confirm its status | Ruse | Bulgaria | Not yet recruiting |
| The medical centre Kanev Ltd. Coordinator of this site? Confirm its status | Ruse | Bulgaria | Not yet recruiting |
| UNIMED Medical Center EOOD Coordinator of this site? Confirm its status | Sevlievo | Bulgaria | Not yet recruiting |
| Multiprofile Hospital For Active Treatment - Shumen AD Coordinator of this site? Confirm its status | Shumen | Bulgaria | Not yet recruiting |
| Military Medical Academy Coordinator of this site? Confirm its status | Sliven | Bulgaria | Not yet recruiting |
| Diagnostics And Consultation Center Convex Ltd. Coordinator of this site? Confirm its status | Sofiya | Bulgaria | Not yet recruiting |
| Medical Center Excelsior OOD Coordinator of this site? Confirm its status | Sofiya | Bulgaria | Not yet recruiting |
| Medical Centre Iskar EOOD Coordinator of this site? Confirm its status | Sofiya | Bulgaria | Not yet recruiting |
| Medical Center Hera EOOD Coordinator of this site? Confirm its status | Sofiya | Bulgaria | Not yet recruiting |
| Specialized Outpatient Medical Care Center – MC Kisyovi LTD SOMCC – MC Kisyovi LTD Coordinator of this site? Confirm its status | Varna | Bulgaria | Not yet recruiting |
| Medical Centre "Pratia Clinic" EOOD Coordinator of this site? Confirm its status | Varna | Bulgaria | Not yet recruiting |
| Medical Center Sv. Ivan Rilski EOOD Coordinator of this site? Confirm its status | Vidin | Bulgaria | Not yet recruiting |
| Specialized Hospital For Active Treatment Of Pneumo-Physiatiric Diseases Vraca /Sbalpfz Vratsa EOOD Coordinator of this site? Confirm its status | Vratsa | Bulgaria | Not yet recruiting |
| Studienpraxis Berlin-Brandenburg Cornelia Seelbinder Und Lennart Schaper GbR Coordinator of this site? Confirm its status | Berlin | Germany | Not yet recruiting |
| Office of Dr. Ishak Teber MD Coordinator of this site? Confirm its status | Berlin | Germany | Not yet recruiting |
| MECS Medical and Clinical Studies Cottbus GmbH Coordinator of this site? Confirm its status | Cottbus | Germany | Not yet recruiting |
| Lungenzentrum Darmstadt Coordinator of this site? Confirm its status | Darmstadt | Germany | Not yet recruiting |
| Klifeck GmbH Coordinator of this site? Confirm its status | Delitzsch | Germany | Not yet recruiting |
| Praxisgemeinschaft Weinkellerstrasse GbR Coordinator of this site? Confirm its status | Hohenstein-Ernstthal | Germany | Not yet recruiting |
| Office of Dr. Christoph Stolpe MD Coordinator of this site? Confirm its status | Ibbenbueren | Germany | Not yet recruiting |
| Dr. Med. Falk Brunner Facharzt Fuer Innere Medizin Und Pneumologie Coordinator of this site? Confirm its status | Leipzig | Germany | Not yet recruiting |
| POIS Sachsen GmbH Coordinator of this site? Confirm its status | Leipzig | Germany | Not yet recruiting |
| Private Practice and Pulmonary Study Centre Coordinator of this site? Confirm its status | Leipzig | Germany | Not yet recruiting |
| IKF Pneumologie GmbH & Co. KG Coordinator of this site? Confirm its status | Mainz | Germany | Not yet recruiting |
| Praxis fuer Pneumologie Dr Silke Mronga und Dr Lukas Jerrentrup Coordinator of this site? Confirm its status | Marburg | Germany | Not yet recruiting |
| Pneumologisch-Internistische Gemeinschaftspraxis Coordinator of this site? Confirm its status | Munchen | Germany | Not yet recruiting |
| IFG Institut fuer Gesundheitsfoerderung GmbH Coordinator of this site? Confirm its status | Rüdersdorf | Germany | Not yet recruiting |
| Lungenzentrum Ulm - Pneumologische Gemeinschaftspraxis Coordinator of this site? Confirm its status | Ulm | Germany | Not yet recruiting |
| Lungenfacharztzentrum Wiesbaden BAG Coordinator of this site? Confirm its status | Wiesbaden | Germany | Not yet recruiting |
| Lungenzentrum Ruhr - Praxis fuer Lungenheilkunde Coordinator of this site? Confirm its status | Witten | Germany | Not yet recruiting |
| Hospital Germans Trias i Pujol Coordinator of this site? Confirm its status | Badalona | Spain | Not yet recruiting |
| Pectus Respiratory Health S.L. Coordinator of this site? Confirm its status | Barcelona | Spain | Not yet recruiting |
| Hospital Vithas Xanit Internacional Coordinator of this site? Confirm its status | Benalmádena | Spain | Not yet recruiting |
| Hospital Clínico San Carlos Coordinator of this site? Confirm its status | Madrid | Spain | Not yet recruiting |
| Hospital Universitario de la Princesa Coordinator of this site? Confirm its status | Madrid | Spain | Not yet recruiting |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Not yet recruiting |
| Hospital Costa del Sol Coordinator of this site? Confirm its status | Marbella | Spain | Not yet recruiting |
| University Hospital Virgen Del Rocio S.L. Coordinator of this site? Confirm its status | Sevilla | Spain | Not yet recruiting |
| Hospital Clinico Universitario Lozano Blesa Coordinator of this site? Confirm its status | Zaragoza | Spain | Not yet recruiting |
| Centre Hospitalier Du Pays D Aix Centre Hospitalier Intercommunal Aix-Pertuis Coordinator of this site? Confirm its status | Aix En Provence | France | Not yet recruiting |
| Centre Hospitalier De Cannes Simone Veil Coordinator of this site? Confirm its status | Cannes Cedex | France | Not yet recruiting |
| Clinique des Cèdres Coordinator of this site? Confirm its status | Cornebarrieu | France | Not yet recruiting |
| Hopital Europeen Marseille Coordinator of this site? Confirm its status | Marseille | France | Not yet recruiting |
| Assistance Publique Hopitaux de Paris Coordinator of this site? Confirm its status | Paris | France | Not yet recruiting |
| Les Hopitaux Universitaires De Strasbourg Coordinator of this site? Confirm its status | Strasbourg Cedex | France | Not yet recruiting |
| Hospital Foch Coordinator of this site? Confirm its status | Suresnes | France | Not yet recruiting |
| Reseau De Sante Mutualiste Coordinator of this site? Confirm its status | Villeurbanne | France | Not yet recruiting |
| Pneumologie Mosbach Coordinator of this site? Confirm its status | Mosbach | Georgia | Not yet recruiting |
| Azienda Sanitaria Locale Di Salerno Coordinator of this site? Confirm its status | Battipaglia | Italy | Not yet recruiting |
| University Hospital Of Ferrara Coordinator of this site? Confirm its status | Ferrara | Italy | Not yet recruiting |
| Azienda Ospedaliero-Universitaria Careggi Coordinator of this site? Confirm its status | Florence | Italy | Not yet recruiting |
| Azienda Ospedaliero Universitaria Ospedali Riuniti Coordinator of this site? Confirm its status | Foggia | Italy | Not yet recruiting |
| IRCCS Ospedale Policlinico San Martino Coordinator of this site? Confirm its status | Genoa | Italy | Not yet recruiting |
| Ospedale Isola Tiberina - Gemelli Isola Coordinator of this site? Confirm its status | Rome | Italy | Not yet recruiting |
| Centrum Medycyny Oddechowej Mroz sp. j. Coordinator of this site? Confirm its status | Bialystok | Poland | Not yet recruiting |
| Bio Zdrowie sp. z o.o. Coordinator of this site? Confirm its status | Białystok | Poland | Not yet recruiting |
| M2M Med. Sp. z o.o. Sp. j. Coordinator of this site? Confirm its status | Chorzow | Poland | Not yet recruiting |
| Centrum Medyczne All-Med Badania Kliniczne Coordinator of this site? Confirm its status | Cracow | Poland | Not yet recruiting |
| Diamond Clinic Sp. z o.o. Coordinator of this site? Confirm its status | Cracow | Poland | Not yet recruiting |
| Santa Sp. z o.o. sp.k. Coordinator of this site? Confirm its status | Kielce | Poland | Not yet recruiting |
| Samodzielny Publiczny Zaklad Opieki Zdrowotnej Uniwersytecki Szpital Kliniczny Nr 1 Im. Norberta Barlickiego Uniwersytetu Medycznego W Lodzi Coordinator of this site? Confirm its status | Lodz | Poland | Not yet recruiting |
| Polimedica Centrum Badan Profilaktyki I Leczenia Sp. z o.o. Coordinator of this site? Confirm its status | Lodz | Poland | Not yet recruiting |
| Centrum Alergologii Sp. z o.o. Coordinator of this site? Confirm its status | Lublin | Poland | Not yet recruiting |
| Makowskie Centrum Medyczne Hamernia Sp. z o.o. Coordinator of this site? Confirm its status | Makow Podhalanski | Poland | Not yet recruiting |
| Ostrowieckie Centrum Medyczne Anna Olech Cudzik Krzysztof Cudzik s.c. Coordinator of this site? Confirm its status | Ostrowiec Świętokrzyski | Poland | Not yet recruiting |
| PULMAG s.c. Coordinator of this site? Confirm its status | Sosnowiec | Poland | Not yet recruiting |
| CENTRUM MEDYCZNE LUCYNA ANDRZEJ DYMEK S.C. Coordinator of this site? Confirm its status | Strzelce Opolskie | Poland | Not yet recruiting |
| ALERGO-MED Specjalistyczna Przychodnia Lekarska Sp. z o. o. Coordinator of this site? Confirm its status | Tarnów | Poland | Not yet recruiting |
| Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy Coordinator of this site? Confirm its status | Warsaw | Poland | Not yet recruiting |
| Centrum Badań Klinicznych Piotr Napora Lekarze Sp. p. Coordinator of this site? Confirm its status | Wroclaw | Poland | Not yet recruiting |
| Angisan Grup S.R.L. Coordinator of this site? Confirm its status | Bragadiru | Romania | Not yet recruiting |
| Institutul de pneumoftiziologie Marius Nasta Coordinator of this site? Confirm its status | Bucharest | Romania | Not yet recruiting |
| Institutul Regional De Gastroenterologie Hepatologie Prof. Dr. Octavian Fodor Cluj Coordinator of this site? Confirm its status | Cluj-Napoca | Romania | Not yet recruiting |
| Spitalul Clinic de Pneumoftiziologie Leon Daniello Coordinator of this site? Confirm its status | Cluj-Napoca | Romania | Not yet recruiting |
| Spitalul Clinic de Boli Infecțioase și Pneumoftiziologie "Victor Babeș" Craiova Coordinator of this site? Confirm its status | Craiova | Romania | Not yet recruiting |
| Spitalul Clinic De Pneumoftiziologie Iasi Coordinator of this site? Confirm its status | Iasi | Romania | Not yet recruiting |
| Cabinet Medical Pneumologie Pneumo Bronho Med Dr. Vancea Dorin Coordinator of this site? Confirm its status | Timisoara | Romania | Not yet recruiting |
| ALIAN s.r.o. Coordinator of this site? Confirm its status | Bardejov | Slovakia | Not yet recruiting |
| Rockmed s.r.o. Coordinator of this site? Confirm its status | Bratislava | Slovakia | Not yet recruiting |
| Zeleznicne zdravotnictvo Kosice s.r.o. Coordinator of this site? Confirm its status | Kosice | Slovakia | Not yet recruiting |
| Plucna ambulancia Hrebenar S.R.O. Coordinator of this site? Confirm its status | Spišská Nová Ves | Slovakia | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.