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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

Full criteria on ClinicalTrials.gov

Sites (89)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Asclepius Medical Center OOD
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DupnitsaBulgariaNot yet recruiting
Multiprofile Hospital For Active Treatment "Dr. Tota Venkova" AD
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GabrovoBulgariaNot yet recruiting
Medical Center Pulmo - 2018 EOOD
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HaskovoBulgariaNot yet recruiting
Medical Center Zdrave-1 OOD
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KozloduyBulgariaNot yet recruiting
University Multiprofile Hospital for Active Treatment Dr Georgi Stranski EAD
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PlevenBulgariaNot yet recruiting
Medical Center FAMA Medical Ltd.
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PlovdivBulgariaNot yet recruiting
Ambulatoria Za Individualna Praktika Za Specializirana Izvunbolnichna Medicinska Pomost Po Alergologia Doktor Talyat Sali Cholak EOOD
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RazgradBulgariaNot yet recruiting
MC Re Spiro OOD
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RazgradBulgariaNot yet recruiting
Medical Center Hermes Ruse Ltd.
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RuseBulgariaNot yet recruiting
The medical centre Kanev Ltd.
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RuseBulgariaNot yet recruiting
UNIMED Medical Center EOOD
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SevlievoBulgariaNot yet recruiting
Multiprofile Hospital For Active Treatment - Shumen AD
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ShumenBulgariaNot yet recruiting
Military Medical Academy
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SlivenBulgariaNot yet recruiting
Diagnostics And Consultation Center Convex Ltd.
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SofiyaBulgariaNot yet recruiting
Medical Center Excelsior OOD
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SofiyaBulgariaNot yet recruiting
Medical Centre Iskar EOOD
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SofiyaBulgariaNot yet recruiting
Medical Center Hera EOOD
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SofiyaBulgariaNot yet recruiting
Specialized Outpatient Medical Care Center – MC Kisyovi LTD SOMCC – MC Kisyovi LTD
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VarnaBulgariaNot yet recruiting
Medical Centre "Pratia Clinic" EOOD
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VarnaBulgariaNot yet recruiting
Medical Center Sv. Ivan Rilski EOOD
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VidinBulgariaNot yet recruiting
Specialized Hospital For Active Treatment Of Pneumo-Physiatiric Diseases Vraca /Sbalpfz Vratsa EOOD
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VratsaBulgariaNot yet recruiting
Studienpraxis Berlin-Brandenburg Cornelia Seelbinder Und Lennart Schaper GbR
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BerlinGermanyNot yet recruiting
Office of Dr. Ishak Teber MD
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BerlinGermanyNot yet recruiting
MECS Medical and Clinical Studies Cottbus GmbH
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CottbusGermanyNot yet recruiting
Lungenzentrum Darmstadt
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DarmstadtGermanyNot yet recruiting
Klifeck GmbH
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DelitzschGermanyNot yet recruiting
Praxisgemeinschaft Weinkellerstrasse GbR
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Hohenstein-ErnstthalGermanyNot yet recruiting
Office of Dr. Christoph Stolpe MD
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IbbenbuerenGermanyNot yet recruiting
Dr. Med. Falk Brunner Facharzt Fuer Innere Medizin Und Pneumologie
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LeipzigGermanyNot yet recruiting
POIS Sachsen GmbH
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LeipzigGermanyNot yet recruiting
Private Practice and Pulmonary Study Centre
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LeipzigGermanyNot yet recruiting
IKF Pneumologie GmbH & Co. KG
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MainzGermanyNot yet recruiting
Praxis fuer Pneumologie Dr Silke Mronga und Dr Lukas Jerrentrup
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MarburgGermanyNot yet recruiting
Pneumologisch-Internistische Gemeinschaftspraxis
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MunchenGermanyNot yet recruiting
IFG Institut fuer Gesundheitsfoerderung GmbH
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RüdersdorfGermanyNot yet recruiting
Lungenzentrum Ulm - Pneumologische Gemeinschaftspraxis
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UlmGermanyNot yet recruiting
Lungenfacharztzentrum Wiesbaden BAG
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WiesbadenGermanyNot yet recruiting
Lungenzentrum Ruhr - Praxis fuer Lungenheilkunde
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WittenGermanyNot yet recruiting
Hospital Germans Trias i Pujol
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BadalonaSpainNot yet recruiting
Pectus Respiratory Health S.L.
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BarcelonaSpainNot yet recruiting
Hospital Vithas Xanit Internacional
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BenalmádenaSpainNot yet recruiting
Hospital Clínico San Carlos
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MadridSpainNot yet recruiting
Hospital Universitario de la Princesa
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MadridSpainNot yet recruiting
Hospital Universitario 12 de Octubre
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MadridSpainNot yet recruiting
Hospital Costa del Sol
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MarbellaSpainNot yet recruiting
University Hospital Virgen Del Rocio S.L.
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SevillaSpainNot yet recruiting
Hospital Clinico Universitario Lozano Blesa
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ZaragozaSpainNot yet recruiting
Centre Hospitalier Du Pays D Aix Centre Hospitalier Intercommunal Aix-Pertuis
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Aix En ProvenceFranceNot yet recruiting
Centre Hospitalier De Cannes Simone Veil
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Cannes CedexFranceNot yet recruiting
Clinique des Cèdres
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CornebarrieuFranceNot yet recruiting
Hopital Europeen Marseille
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MarseilleFranceNot yet recruiting
Assistance Publique Hopitaux de Paris
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ParisFranceNot yet recruiting
Les Hopitaux Universitaires De Strasbourg
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Strasbourg CedexFranceNot yet recruiting
Hospital Foch
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SuresnesFranceNot yet recruiting
Reseau De Sante Mutualiste
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VilleurbanneFranceNot yet recruiting
Pneumologie Mosbach
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MosbachGeorgiaNot yet recruiting
Azienda Sanitaria Locale Di Salerno
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BattipagliaItalyNot yet recruiting
University Hospital Of Ferrara
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FerraraItalyNot yet recruiting
Azienda Ospedaliero-Universitaria Careggi
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FlorenceItalyNot yet recruiting
Azienda Ospedaliero Universitaria Ospedali Riuniti
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FoggiaItalyNot yet recruiting
IRCCS Ospedale Policlinico San Martino
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GenoaItalyNot yet recruiting
Ospedale Isola Tiberina - Gemelli Isola
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RomeItalyNot yet recruiting
Centrum Medycyny Oddechowej Mroz sp. j.
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BialystokPolandNot yet recruiting
Bio Zdrowie sp. z o.o.
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BiałystokPolandNot yet recruiting
M2M Med. Sp. z o.o. Sp. j.
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ChorzowPolandNot yet recruiting
Centrum Medyczne All-Med Badania Kliniczne
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CracowPolandNot yet recruiting
Diamond Clinic Sp. z o.o.
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CracowPolandNot yet recruiting
Santa Sp. z o.o. sp.k.
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KielcePolandNot yet recruiting
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Uniwersytecki Szpital Kliniczny Nr 1 Im. Norberta Barlickiego Uniwersytetu Medycznego W Lodzi
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LodzPolandNot yet recruiting
Polimedica Centrum Badan Profilaktyki I Leczenia Sp. z o.o.
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LodzPolandNot yet recruiting
Centrum Alergologii Sp. z o.o.
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LublinPolandNot yet recruiting
Makowskie Centrum Medyczne Hamernia Sp. z o.o.
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Makow PodhalanskiPolandNot yet recruiting
Ostrowieckie Centrum Medyczne Anna Olech Cudzik Krzysztof Cudzik s.c.
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Ostrowiec ŚwiętokrzyskiPolandNot yet recruiting
PULMAG s.c.
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SosnowiecPolandNot yet recruiting
CENTRUM MEDYCZNE LUCYNA ANDRZEJ DYMEK S.C.
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Strzelce OpolskiePolandNot yet recruiting
ALERGO-MED Specjalistyczna Przychodnia Lekarska Sp. z o. o.
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TarnówPolandNot yet recruiting
Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy
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WarsawPolandNot yet recruiting
Centrum Badań Klinicznych Piotr Napora Lekarze Sp. p.
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WroclawPolandNot yet recruiting
Angisan Grup S.R.L.
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BragadiruRomaniaNot yet recruiting
Institutul de pneumoftiziologie Marius Nasta
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BucharestRomaniaNot yet recruiting
Institutul Regional De Gastroenterologie Hepatologie Prof. Dr. Octavian Fodor Cluj
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Cluj-NapocaRomaniaNot yet recruiting
Spitalul Clinic de Pneumoftiziologie Leon Daniello
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Cluj-NapocaRomaniaNot yet recruiting
Spitalul Clinic de Boli Infecțioase și Pneumoftiziologie "Victor Babeș" Craiova
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CraiovaRomaniaNot yet recruiting
Spitalul Clinic De Pneumoftiziologie Iasi
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IasiRomaniaNot yet recruiting
Cabinet Medical Pneumologie Pneumo Bronho Med Dr. Vancea Dorin
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TimisoaraRomaniaNot yet recruiting
ALIAN s.r.o.
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BardejovSlovakiaNot yet recruiting
Rockmed s.r.o.
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BratislavaSlovakiaNot yet recruiting
Zeleznicne zdravotnictvo Kosice s.r.o.
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KosiceSlovakiaNot yet recruiting
Plucna ambulancia Hrebenar S.R.O.
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Spišská Nová VesSlovakiaNot yet recruiting

This page is information, not medical advice. Discuss any trial with your doctor.