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Eco-Friendly asthma inhaler passes safety check in major trial

NCT ID NCT06264674

Disease control Sponsor: Chiesi Farmaceutici S.p.A. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Sep 11, 2026 · Updated 3 times

Summary

This study tested a new, environmentally friendly propellant (HFA-152a) in a common asthma inhaler (CHF5993) to see if it is as safe as the current propellant. Over 800 adults with moderate to severe asthma used the inhaler twice daily for 12 weeks. The main goal was to check for any immediate breathing problems after using the new inhaler.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
CHF5993 (a combination of beclometasone, formoterol, and glycopyrronium) in an inhaler with a new propellant (HFA-152a)
What this could lead to
If successful, this could lead to a more environmentally friendly asthma inhaler that works just as safely as current ones.
What could go wrong
This trial is focused on safety and uses a new propellant, so it may not show any improvement in asthma control. The results are specific to moderate to severe asthma and may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

827 people

The number who actually took part.

Started

Nov 2023

Finished

Feb 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Subject's written informed consent obtained prior to any study related procedure; * Male and female adults aged ≥ 18 and ≤ 75; * Body mass index (BMI) within the range of 18.0 to 35.0 kg/m2 inclusive; * Non-smokers or ex-smokers who smoked \< 10 pack-years (pack-years = the number of cigarette packs per day x the number of years) and stopped smoking \> 1 year (6 months for e-cigarettes) prior to screening; * Diagnosis of asthma: physician-diagnosed asthma for at least * 6 months and with diagnosis before the age of 50 years; * Stable asthma therapy: a stable treatment with medium/high doses of inhaled corticosteroids (ICS) + long-acting β-agonist (LABA) + long-acting muscarinic antagonist (LAMA) (fixed or free combination) or medium/high doses of ICS+LABA (fixed or free combination) for at least 4 weeks before screening (medium and high-dose ICS defined as BDP non-extrafine \> 500-1000 μg and \> 1000 μg respectively, or estimated clinical comparable dose). * Subjects must have a cooperative attitude and the ability to be trained to use correctly the pMDI inhalers and e-Diary, to be able to read/write, to be able to perform the required outcomes measurements (e.g., technically acceptable spirometry, e-Diary completion) and the ability to understand the risks involved. Exclusion Criteria: * History of near fatal asthma, hospitalisation for asthma in intensive care unit which in the judgement of the Investigator may place the subject at undue risk, emergency room access for asthma in the previous 6 months before enrolment; * Asthma exacerbation requiring systemic corticosteroids (SCS) or emergency room admission or hospitalisation within 4 weeks prior to study entry and/or during the run-in period (to be checked again prior to randomisation); * Non-permanent asthma: exercise-induced, seasonal asthma (as the only asthma-related diagnosis) not requiring daily asthma control medecine

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Conditions

The condition(s) this trial relates to.

asthma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Asthma

Contacts and locations

Locations

  • "AIPSMP Yuskyan Aliosman" Ltd

    Momchilgrad, Bulgaria

  • "George Papanikolaou" General Hospital of Thessaloniki

    Thessaloniki, 570 10, Greece

  • "IPSMCPP-D-R Veleva" EOOD

    Burgas, Bulgaria

  • "Medical Center Sun i Zdrave"

    Sofia, Bulgaria

  • ALERGO-MED Specjalistyczna Przychodnia Lekarska Sp. z o. o.

    Tarnów, 33-100, Poland

  • ASMP MC Kissiovi Ltd.

    Varna, 9000, Bulgaria

  • ATOPIA Niepubliczny Zakład Opieki Zdrowotnej

    Krakow, 35-159, Poland

  • Ambulatory for Specialized Outpatient Medical Care - Individual Practice

    Rousse, 7000, Bulgaria

  • Amphia Hospital

    Breda, 4818 CK, Netherlands

  • Angisan Grup Srl

    Bragadiru, 769764, Romania

  • Athanasios Xanthopoulos Praxis für Pneumologie

    Fürstenwalde, 15517, Germany

  • Azienda Ospedaliera dei colli - Ospedale Monaldi

    Naples, 80131, Italy

  • BKS Research Kft.,

    Hatvan, H-3000, Hungary

  • Bradford Teaching Hospitals NHS Foundation Trust

    Bradford, BD9 6RJ, United Kingdom

  • CLINICAL BEST SOLUTIONS Fiutkowski Sp. z o.o.

    Warsaw, 41-100, Poland

  • Centrul Medical Sana (SANA S.R.L.)

    Bucharest, 011025, Romania

  • Centrum Badań Klinicznych

    Wroclaw, 51-162, Poland

  • Centrum Medycyny Oddechowej, Mróz Spółka Jawna

    Bialystok, 15-044, Poland

  • Centrum Medyczne Lucyna i Andrzej DymeK

    Strzelce Opolskie, 47-100, Poland

  • Centrum Nowoczesnych Terapii "Dobry Lekarz"

    Krakow, 31-011, Poland

  • Clinic for Pulmonary Diseases, University Clinical center of Serbia

    Belgrade, 11000, Serbia

  • Clinic for Pulmonology, University Clinical Center Kragujevac

    Kragujevac, Serbia

  • Clinic for Pulmonology, University Clinical Center Kragujevac.

    Kragujevac, 34000, Serbia

  • Clinica Malattie Respiratorie e allergologia IRCCS Ospedale Policlinico San Martino

    Genova, 16132, Italy

  • Clinical Centre of Niš Clinic for Lung Diseases

    Niš, 18000, Serbia

  • Clinical Hospital of Infectious Diseases and Pneumophysiology

    Timișoara, Romania

  • Clinical Hospital of Infectious Diseases and Pneumophysiology Dr.Victor Babeș Timișoara

    Timișoara, Romania

  • Clinmedica Research Sp. Z O.O.

    Skierniewice, 96-100, Poland

  • Complejo Hospitalario Universitario de Santiago Hospital Clínico Universitario de Santiago

    Santiago de Compostela, 15706, Spain

  • Curatio, Jsc

    Tbilisi, 0114, Georgia

  • Diagnostic Consultative Centre 1-

    Sliven, 8801, Bulgaria

  • Diagnostics and Consultation Center Convex EOOD

    Sofia, 1680, Bulgaria

  • Diamond Clinic Spółka z ograniczoną odpowiedzialnością

    Krakow, 31-559, Poland

  • Dr. med. Thomas Ginko Facharzt für Lungen- und Bronchialheilkunde

    Bonn, 53119, Germany

  • EB FlevoResearch BV

    Almere Stad, 1311 RL, Netherlands

  • Erzsébet Gondozóház

    Gödöllő, H-2100, Hungary

  • First Medical Center LLC

    Tbilisi, 0180, Georgia

  • GEO HOSPITALS Zestaphoni Ambulatory Centre

    Zestaponi, Georgia

  • Gelre Hospitals Zutphen (Gelre ziekenhuizen Zutphen)

    Zutphen, 7207 AE, Netherlands

  • Geo Hospitals Gardabani Multiprofile Medical Centre

    Gardabani, Georgia

  • Geo Hospitals Gurjaani Multiprofile Medical Centre

    Gurjaani, Georgia

  • Geo Hospitals Sagarejo Multiprofile Medical Centre

    Sagarejo, Georgia

  • Geo Hospitals Tbilisi Multiprofile Medical Center

    Tbilisi, 0144, Georgia

  • Giromed Institute Parc Científic i Tecnològic Universitat de Girona

    Girona, 17003, Spain

  • Guy's & St Thomas'NHS Foundation Trust of Royal Brompton Hospital

    London, UB9 6JH, United Kingdom

  • Hornmed, s.r.o

    Brno, 618 00, Czechia

  • Hospital General Universitario de Castellón

    Castellon, 12004, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • IKF Pneumologie Frankfurt Clinical Research Centre Respiratory Medicine IFS - Interdisziplinäres Facharztzentrum

    Frankfurt, 60596, Germany

  • IMUNOALERGOLÓGIA JZ, s.r.o.

    Žilina, 010 01, Slovakia

  • INFER-MED Kft

    Pécs, Hungary

  • Imermedi-Imereti Regional Medical Center. (Terjolamedi) Ltd.

    T'erjola, 2400, Georgia

  • Institut für Allergie- und Asthmaforschung

    Berlin, 12159, Germany

  • Institute for Pulmonary Diseases of Vojvodina.

    Kamenica, 21204, Serbia

  • KLB Gesundheitsforschung Lübeck GmbH

    Lübeck, 23552, Germany

  • KOMA Kardioprax, s.r.o.

    Žilina, 010 01, Slovakia

  • Klinische Forschung Berlin

    Berlin, 10787, Germany

  • Lekarze Specjaliści - J. Małolepszy I Partnerzy

    Wroclaw, 54-239, Poland

  • Lungenpraxis Hohenzollerndamm

    Berlin, 10717, Germany

  • Lungenpraxis Witten

    Witten, 58452, Germany

  • MHAT Sliven to MMA Sofia

    Sliven, Bulgaria

  • Makowskie Centrum Medyczne MCM "Hamernia" Maków Podhalański

    Maków Podhalański, 34-220, Poland

  • Małopolskie Centrum Alergologii sp. z o.o.

    Krakow, 31-624, Poland

  • MediTrial s.r.o.

    Jindřichův Hradec, 37701, Czechia

  • Medical Center "New Rehabilitation Center" Ltd

    Stara Zagora, 6003, Bulgaria

  • Medical Center "Syrtuin" Ltd

    Sofia, Bulgaria

  • Medical Center "Zdrave -1"

    Kozloduy, Bulgaria

  • Medical Center Hera EOOD, 20 Klisura str., fl. 2,

    Sofia, 1510, Bulgaria

  • Medicines Evaluation Unit, Langley Building, Wythenshawe Hospital

    Manchester, M23 9QZ, United Kingdom

  • Medihelp Ltd

    Samtredia, Georgia

  • Medsana Bucharest Medical Center Srl

    Bucharest, Romania

  • Michał Bogacki Dobrostan

    Wroclaw, 53-301, Poland

  • Multi-profile Hospital for Active Treatment Zdraveto 2012 Ltd.,

    Sofia, 1618, Bulgaria

  • Multiprofile Hospital For Active Treatment "Knyaginya Klementina" Sofia EAD,

    Sofia, 1233, Bulgaria

  • Multiprofile Hospital For Active Treatment - Shumen AD,

    Shumen, 9700, Bulgaria

  • Municipal Institute for lung diseases and tuberculosis

    Belgrade, Serbia

  • National Institute of Pneumology Marius Nasta

    Bucharest, 050159, Romania

  • Nemocnica s poliklinikou Š. Kukuru Michalovce

    Michalovce, 071 01, Slovakia

  • Nemocnice Jihlava, Plicní oddělení

    Jihlava, 586 01, Czechia

  • Neudorfer Lungenpraxis

    Duisburg, 47057, Germany

  • Ostrowieckie Centrum Medyczne Spółka Cywilna Anna Olech-Cudzik, Krzysztof Cudzik

    Ostrowiec Świętokrzyski, 27-400, Poland

  • POIS Sachsen GmbH

    Leipzig, 04347, Germany

  • PULMAG Grzegorz Gąsior, Marzena Kociołek spółka cywilna

    Sosnowiec, 41-205, Poland

  • Plicní středisko Teplice s.r.o.

    Teplice, 415 01, Czechia

  • Pneumologisches Studienzentrum München

    München, 12159, Germany

  • Pneumology dpt., Fakultní Thomayerova nemocnice

    Prague, 14000, Czechia

  • Pneumology dpt., Poliklinika Budějovická, MEDICON a.s.

    Prague, 140 00, Czechia

  • Policum Berlin Studien GmbH Friedenau

    Berlin, 12157, Germany

  • Poliklinika ČK PLUS Alian s.r.o

    Bardejov, 085 01, Slovakia

  • Portsmouth Hospitals University NHS Trust

    Portsmouth, PO6 3LY, United Kingdom

  • Praxis für Pneumologie und Allergologie

    Leipzig, 04299, Germany

  • Private Health Care MEDYK-KRAK Sp. o.o.

    Krakow, 31-455, Poland

  • Prvni plicni ambulance s.r.o

    Prague, 190 00, Czechia

  • Prywatna praktyka lekarska. Gabinet pediatryczno - alergologiczny

    Bialystok, 15-430, Poland

  • Prywatny Gabinet Lekarski Małgorzata Pawlukiewicz

    Rzeszów, 35-051, Poland

  • Prywatny gabinet internistyczno-alergologiczny prof. Zenon Siergiejko

    Bialystok, 15-010, Poland

  • Pľucna ambulancia MUDr. Miroslava Undesser

    Dunajská Streda, 929 01, Slovakia

  • Pľúcna ambulacia - MUDr. Slavomír Hrebenár

    Spišská Nová Ves, 05201, Slovakia

  • Queen Mary University of London

    London, EC1M6BQ, United Kingdom

  • Revamed Kft

    Nyíregyháza, H-4400, Hungary

  • SMO Zentrum für klinische Studien

    Magdeburg, 39120, Germany

  • Siteworks Prüfzentrum Schleswig GmbH

    Schleswig, 24837, Germany

  • Specialized Hospital For Active Treatment Of Pneumo-Phthisiatric Diseases Dr. Dimitar Gramatikov

    Rousse, 7002, Bulgaria

  • Specialized Hospital For Active Treatment Of Pneumo-Phthisiatric Diseases Dr. Dimitar Gramatikov - Ruse Ltd.

    Rousse, 7002, Bulgaria

  • Spital Judetean de Urgenta Bihor

    Oradea, Romania

  • Spitalul Clinic de Boli Infecțioase și Pneumoftiziologie "Victor Babeș" Craiova

    Craiova, 200515, Romania

  • Spitalul Clinic de Pneumoftiziologie Leon Daniello

    Cluj-Napoca, 400332, Romania

  • Spitalul Clinic de Pneumoftiziologie Leon Daniello

    Cluj-Napoca, 400394, Romania

  • Spitalul clinic de Pneumoftiziologie Palazu Mare Constanta

    Constanța, 900002, Romania

  • Studienpraxis Berlin-Brandenburg Cornelia Seelbinder Und Lennart Schaper GbR

    Berlin, 10119, Germany

  • University First Multiprofile Hospital for Active Treatment -Sofia "St. Joan Krastilel" EAD

    Sofia, 1142, Bulgaria

  • University of Debrecen, Infectology Clinic Pulmonary unit

    Debrecen, Hungary

  • University of Messina, Allergy and Clinical Immunology Unit, Department of Experimental and Clinical Medicine

    Messina, 98125, Italy

  • Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego

    Lodz, 90-153, Poland

  • Uniwersytet Medyczny w Bialymstoku Wydzial Nauk o Zdrowiu Klinika Alergologii i Chorób Wewnetrznych

    Bialystok, 15-276, Poland

  • Užice General Hospital Miloša Obrenovića 17.

    Užice, 31000, Serbia

  • Vitamed Galaj I Cichomski Sp. J.

    Bydgoszcz, 85-079, Poland

  • Árkádia Egészségközpont

    Szombathely, H-9700, Hungary

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