Study on the Safety of CHF5993 Inhaler with HFA-152a vs. HFA-134a in Patients with Moderate to Severe Asthma

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What is this study about?

This clinical trial is focused on studying the safety of a treatment for people with asthma, a condition that affects the airways in the lungs and can cause breathing difficulties. The study will compare two formulations of a medication known by the code name CHF5993. This medication is a combination of three active substances: glycopyrronium bromide, formoterol fumarate dihydrate, and beclometasone dipropionate anhydrous. These substances work together to help open the airways and reduce inflammation, making it easier to breathe. The trial will also use salbutamol as a rescue medication, which is commonly used to quickly relieve asthma symptoms.

The purpose of the study is to evaluate the safety of the two formulations of CHF5993 in people with moderate to severe asthma. Participants will be randomly assigned to one of two groups, each receiving a different formulation of the medication. The study will last for 12 weeks, during which participants will use an inhaler to take their assigned medication. Throughout the study, participants will have regular visits to monitor their health and assess how their lungs are functioning. The study is designed to be double-blind, meaning neither the participants nor the researchers will know which formulation each participant is receiving, to ensure unbiased results.

Participants will be asked to use an electronic diary to record their symptoms and any use of the rescue medication, salbutamol. The study aims to provide valuable information on the safety of the new formulation of CHF5993 and its potential to help people with asthma manage their condition more effectively. The trial will help determine if the new formulation is as safe as the existing one, with a focus on any potential for causing bronchoconstriction, which is a narrowing of the airways that can make breathing difficult.

1 Joining the study

Upon joining the study, the participant will be randomly assigned to one of two groups. Each group will receive a different formulation of the same medication, CHF5993, which is used to treat asthma.

The medication is administered using a pressurized inhaler, which delivers a specific dose with each use.

2 Medication administration

Participants will use the inhaler twice daily, once in the morning and once in the evening. Each actuation delivers a dose of 200 micrograms of beclometasone dipropionate, 6 micrograms of formoterol fumarate, and 12.5 micrograms of glycopyrronium bromide.

The inhaler should be used as instructed to ensure the correct dosage is administered.

3 Regular assessments

Participants will attend regular study visits on Day 1, Day 7, Week 4, and Week 12. During these visits, lung function tests will be conducted to measure the forced expiratory volume (FEV1) at various time points after taking the medication.

These tests help assess the effectiveness and safety of the medication.

4 Monitoring and recording

Participants will be required to keep a daily electronic diary to record their asthma symptoms and any use of rescue medication, such as salbutamol.

This information is crucial for evaluating the overall control of asthma symptoms during the study.

5 Completion of the study

The study will last for 12 weeks. At the end of this period, a final assessment will be conducted to evaluate the participant’s response to the treatment.

The results will contribute to understanding the safety and effectiveness of the medication formulations being tested.

Who Can Join the Study?

  • You must give your written consent before any study-related procedures begin.
  • You should be cooperative and able to learn how to use the inhalers and e-Diary correctly. You should also be able to read and write, perform necessary tests like spirometry (a breathing test), and understand the risks involved. If you already use a spacer device with your inhaler, you will need to continue using it during the study.
  • If you are a woman who can have children, you must use a reliable birth control method if your partner is fertile. If your partner is not fertile, birth control is not needed. If you are a woman who cannot have children, you must be post-menopausal (no longer having periods) or permanently unable to become pregnant.
  • You must be between 18 and 75 years old.
  • Your body mass index (BMI), which is a measure of body fat based on height and weight, should be between 18.0 and 35.0.
  • You should be a non-smoker or have quit smoking more than a year ago (or more than 6 months ago for e-cigarettes) and have smoked less than 10 pack-years. A pack-year is the number of cigarette packs smoked per day multiplied by the number of years you smoked.
  • You must have been diagnosed with asthma by a doctor for at least 6 months, and the diagnosis should have been made before you turned 50.
  • Your asthma treatment should be stable, meaning you have been using medium to high doses of inhaled corticosteroids (ICS) with a long-acting beta-agonist (LABA) and possibly a long-acting muscarinic antagonist (LAMA) for at least 4 weeks before the study. If you use a spacer with your inhaler, you should continue using it during the study.
  • Your asthma should be controlled or partly controlled, with a score of less than 1.5 on the Asthma Control Questionnaire (ACQ-7) at the start of the study.
  • Your lung function, measured by forced expiratory volume in 1 second (FEV1), should be between 40% and 90% of the normal value for someone of your age and size, after stopping bronchodilator medication for a short time before the test.
  • You should have a positive response to a bronchodilator test, which means your FEV1 should increase by at least 12% and 200 mL after using a bronchodilator medication like salbutamol. If this response is not seen at the first test, it can be repeated before the study starts. If still not met, past documentation of a positive response or a positive bronchial challenge test within the last 24 months can be used.

Who Cannot Join the Study?

  • Patients with asthma that is not well controlled, meaning their symptoms are not managed effectively.
  • Patients who have other serious health conditions that could interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who are currently participating in another clinical trial.
  • Patients who have had a recent respiratory infection, which is an infection in the lungs or airways.
  • Patients who have a history of severe allergic reactions.
  • Patients who are unable to use the inhaler device properly.
  • Patients who have a known allergy to any of the study medications.
  • Patients who have smoked tobacco or used nicotine products within the last 6 months.
  • Patients who have a history of drug or alcohol abuse.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Diamond Clinic Sp. z o.o. Cracow Poland
University Of Debrecen Debrecen Hungary
Velocity Clinical Research Luebeck GmbH Luebeck Germany
Fakultni Nemocnice Brno Brno Czechia
IRCCS Ospedale Policlinico San Martino Genoa Italy
Universidade De Santiago De Compostela Santiago De Compostela Spain
Hospital Universitario De Salamanca Salamanca Spain
Azienda Ospedaliera Universitaria Federico II Di Napoli Naples Italy
Complex Oncological Center – Shumen EOOD Shumen Bulgaria
Berufsausuebungsgemeinschaft Bag Prof Dr. Med Gerhard Hoheisel Dr. Med Andreas Bonitz GbR Leipzig Germany
Hospital Universitario 12 De Octubre Madrid Spain
Amphia Hospital Breda The Netherlands
Geniko Nosokomeio Thessalonikis George Papanikolaou Thessaloniki Greece
Centrum Medycyny Oddechowej Mroz Sp. j. Bialystok Poland
Centrum Nowoczesnych Terapii Dobry Lekarz Sp. z o.o. Cracow Poland
Pneumologie, Allergologie Praxis Dr. Thomas Ginko Bonn Germany
Diagnostics And Consultation Center Convex Ltd. Sofia Bulgaria
Alergo-Med Specjalistyczna Przychodnia Lekarska Sp. z o.o. Tarnow Poland
NZOZ Krak-Medyk Sp. Z o.o Cracow Poland
Uniwersytecki Szpital Kliniczny W Bialymstoku Bialystok Poland
Centrum Medyczne LukaMed Joanna Łuka Chojnice Poland
Prywatny Gabinet Internistyczno-Alergologiczny Zenon Siergiejko Bialystok Poland
Fakultni Thomayerova nemocnice Prague Czechia
Michał Bogacki – DOBROSTAN Wroclaw Poland
Institutul De Pneumoftiziologie Marius Nasta Bucharest Romania
Centrum Badan Klinicznych Piotr Napora Lekarze sp.p. Wroclaw Poland
Hospital General Universitario De Castellon Castello De La Plana Spain
Klinische Forschung Berlin GbR Berlin Germany
University Hospital Olomouc Olomouc Czechia
Gelre Hospitals Zutphen The Netherlands
Stichting Martini Ziekenhuis Groningen The Netherlands
Azienda Ospedaliero Universitaria Di Sassari Sassari Italy
Institutul Regional De Gastroenterologie Hepatologie Prof. Dr. Octavian Fodor Cluj Cluj Napoca Romania
Bioclinic S.A. Thessaloniki Greece
Clinical Research Hamburg GmbH Hamburg Germany
Silmedic Sp. z o.o. Katowice Poland
Vitamed Galaj I Cichomski Sp. j. Bydgoszcz Poland
Vita Longa Sp. z o.o. Katowice Poland
Smo Md GmbH Magdeburg Germany
Spitalul Clinic De Boli Infectioase Si Pneumoftiziologie Victor Babes Craiova Craiova Romania

Other Sites

Site Name City Country Status
Multiprofile Hospital For Active Treatment Knyaginya Klementina Sofia EAD Sofia Bulgaria
Nemocnice Jihlava prispevkova organizace Jihlava Czechia
Hornmed s.r.o Brno Czechia
Institut für Allergie- und Asthmaforschung Berlin Berlin Germany
PPX Pneumologische Praxis Xanthopoulos Fürstenwalde Germany
Research Center for Medical Studies (RCMS) Berlin Germany
Nova-Clin Medical Research Center S.R.L. Timisoara Romania
BKS Research Kft. Hatvan Hungary
Universita Degli Studi Di Messina Messina Italy
Niepubliczny Zaklad Opieki Zdrowotnej Centrum Medyczne Promimed Sp. z o.o. sp.k. Cracow Poland
Pneumologisches Studienzentrum München-West Munich Germany
Lungenpraxis – Praxisgemeinschaft Witten Witten Germany
Mmbcoda Ciqtri Hvxs Elzy Sofia Bulgaria
Ukljdfyyhh Gavgvcc Heyqxysz On Ijneqklm Ioannina Greece
Ipr Phjcazuxjal Gqca &nldy Ckw Kp Frankfurt Germany
Itpvukfvi Kgic Pecs Hungary
Hsyvtchx of Iagopfaorq Drolslyg akx Pebrpbwlsa Vohuuu Bmcdnn Turhkvrgu Timisoara Romania
Izmjydj Aszrrtl &gxlhil Pvbxn Fkedet Connul Athens Greece
Rerozhi Kkcb Nyiregyhaza Hungary
Poua Mmlbkq Jmzm Vipjm Evtrxokxgd Emcecylohlxsf Iinkvxqzuqd Pecs Hungary
K &hczw B Sqkggxtq Knig Szombathely Hungary
Mgiegjl Bzpvzblhj Cvrlcc Bucharest Romania
Smcqfowd Ceqdil Dl Pizsjhjfaubckgywn Cqkivntam Palazu Mare Romania
Awalbdi Gmoe Slpxwt Bragadiru Romania
Picsbdkl afyzrflija Hfvtcomu svggan Spisska Nova Ves Slovakia
Prmmron aavybirmie (odyhhskyp cypzuez &herfkg Dmdjltidd Sndeuk Dunajská Streda Slovakia
Novpmooqv s Pptgwxunntir Sowypef Khsprv Mzqlkhouid Michalovce Slovakia
Ikjvnhcfqqznnpun Ja sfbbcl Zilina Slovakia
Jurdhh sgz Nizna Mysla Slovakia
Kzrx Kfjhdfowdv skijhk Zilina Slovakia
&nfowpsikxuy Mrzxd dwmkf Swlsokllsumdzuf Hlnziprc Battipaglia Italy
Apyg Fjm Skbhw Lgpnhnu Hpzkmjjv Milan Italy
Meeoycxpb sttahd Jindřichův Hradec Czechia
Pbqdu pswrho ackoyztyy sjbnnt Prague Czechia
Ndrquroie Laxwepjsmscr Duisburg Germany
Mbewrqa Cnlxgh &ihxeyp Sjc i Ztcdhr 1giuaoqm Laz Oprtx kenvo dpqkhygc Sofia Bulgaria
Aebgpsrpyc Foa Sjyttbgdafr Othrvpvtvf Mchocbw Chgabjrwdwqgigs Phtshqnllput Nhsorln Efxddxrz Rygn Ruse Bulgaria
Mbjbfxj Cuzovv &dfgoogyauwyqadgqpscl Lgcl Sofia Bulgaria
Anac Mz Kybmqbsd Varna Bulgaria
Mnht Sldykf tf Mpd Sxyjp Sliven Bulgaria
Djwxflungs Cubetcwgwwwh Chsakb 1 Sqzttj Lofh Silven Bulgaria
Avranj Df Yupaklq Afeooaqr Ewkd Momchilgrad Bulgaria
Itowxmtiun Veowwy Burgas Bulgaria
Pmgwhgwx Ahnninqmgnr Ufstbvenppubn Sscirds Kazmwhagf Lodz Poland
Mxc Hqiglinm Se zrx Makow Podhalanski Poland
Spnom Miucabh Sdl Z Oix Lodz Poland
Ckhleajni Strzelce Opolskie Poland
Cdxbxz Mbrnwj Arpev Cadiz Spain
Circbedwwr Rlefbrie sld z omyh Skierniewice Poland
Gysvjzg Jeisikhbotgzsdc Ahshwc Nrxpdaauyucy Zsfupx Oxwsre Zcxyfhsvzh Pgemdpab Sfxmvfmmsiygowc Cracow Poland
Sfjgvoozw Pzgmckkousq Sfzrgddsbn Rwknopqbsm Schleswig Germany
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Pdavgymw Gzdtvdn Ltlmrcvm Mgsceokwmp Plvlirswqiww Rzeszcow Poland
Piqdth Gafezlev Gztilx Mjzvtzh Ksxmwgpa sskp Sosnowiec Poland
Uhnvifinrs Fcqqc mfqwejhqmido hhrvwtgb fjk adffbb trsarrbyp Sqbrp Slh Jfct Krmoxqbfr Ero Sofia Bulgaria
Mjimsku Cmirot Ssk I Zgprff Lthq Sofia Bulgaria
Sdguzizt Czuycw Jhmnxyrh Dt Uuiwglg Bbxwt Oradea Romania
Mfrpnek Csiqgl Zdmfnafa Oon Kozloduy Bulgaria
Ex Beckor Aourfy Bdgz Almere The Netherlands
Ooswxdaqclbc Cuidsli Mxcpmkow Askf Ofqsc Cnqclk Kixxzuoib Cmmaqg smnx Ostrowiec Swietokrzyski Poland
Shdj Msqryglpqy Sydoga Bucharest Romania
Chgmfyxa Bfam Svduushsb Szd z ofta Snqn Lublin Poland
Aogcb sxjouk Bardejov Slovakia
Pixd Skcldik Gvpu Leipzig Germany
Sesmkslq Cdszbi Da Paxytqcjpqjfuulzk Lfro Dlhzxdjz Cluj Napoca Romania
Ldotmxn Slnxhouwgjs Js Mtppyvoawj I Piijflnkb Wroclaw Poland
Ptvuwsr Bkkixn Slfglni Gfoq Berlin Germany
Sgimnkbpeew Hakokccq Fxh Aecnmk Toshmoaxx Or Plubyawammvilnktcxl Dqpoqbgh Dcv Dnzekkp Gfkmypzjypmwahz Ruse Bulgaria
Ekojarzo Goqotpbepy Khhf Godollo Hungary
Pnvsqs Sgvvfhwlp Tlqljba silnxo Teplice Czechia
Mmsspvc ameg Prague Czechia
Mzjwladmukt Cmulrxg Asvbuidsflj Sjo z okmp Cracow Poland
Srttoxythuvwc Bbsmwtfvqtwirljbsg Cxcfukcr Slbphlxsga Ucr Lglerdk Syugzyv Gjg Berlin Germany
Mkfqlgn Crlaxa Nqd Rxejmyrqxryazw Chxscm Ejjl Stara Zagora Bulgaria
Gwiwrvp Icqhcsuzc Srkzza Barcelona Spain
Pklxnhsa Phirbhcc Lmmntbvl Gyztqwb Ppnqcynztuamforukxhvyohuwvj Agvp Pukgqxike Bialystok Poland

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Bulgaria Bulgaria
Not recruiting
13.11.2023
Czechia Czechia
Not recruiting
13.11.2023
Germany Germany
Not recruiting
13.11.2023
Greece Greece
Not recruiting
13.11.2023
Hungary Hungary
Not recruiting
13.11.2023
Italy Italy
Not recruiting
13.11.2023
Poland Poland
Not recruiting
13.11.2023
Romania Romania
Not recruiting
13.11.2023
Slovakia Slovakia
Not recruiting
13.11.2023
Spain Spain
Not recruiting
13.11.2023
The Netherlands The Netherlands
Not recruiting
13.11.2023

Trial locations

CHF5993 pMDI with HFA-152a is an inhaler medication used in the trial to help manage asthma symptoms. It contains a combination of active ingredients that work together to open up the airways, making it easier to breathe. The HFA-152a refers to the type of propellant used in the inhaler, which helps deliver the medication into the lungs.

CHF5993 pMDI with HFA-134a is another inhaler medication used in the trial, similar to the one with HFA-152a. It also contains the same combination of active ingredients to help relieve asthma symptoms by opening the airways. The difference lies in the type of propellant, HFA-134a, which is used to deliver the medication into the lungs.

Investigated Diseases:

Asthma – Asthma is a chronic respiratory condition characterized by inflammation and narrowing of the airways, leading to difficulty in breathing. It often presents with symptoms such as wheezing, coughing, shortness of breath, and chest tightness. The severity of asthma can vary, with some individuals experiencing mild symptoms and others having more severe episodes. Asthma is often triggered by allergens, exercise, cold air, or stress. In moderate to severe cases, as described by the Global Initiative for Asthma (GINA) guidelines, individuals may require regular medication to control symptoms and prevent exacerbations. The condition can fluctuate over time, with periods of stability and episodes of worsening symptoms.

Trial ID:
2023-503333-22-00
Protocol code:
CLI-05993AB6-03
Trial Phase:
Therapeutic confirmatory (Phase III)

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