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Taking peoplePhase 2

Comparing two asthma inhalers with different propellants in adults

Tests whether a new-propellant asthma inhaler works like the current one in adults.

Key facts

Who runs it
Chiesi Farmaceutici S.p.A.
Where
Gorna Oryahovitsa, Haskovo, Kozloduy, Lovech, Pernik, Pleven, Plovdiv, Razgrad, Ruse, Sliven, Sofia, Sofiya, Stara Zagora, and Varna, BulgariaSee the 21 sitesAlso in 16 other countries, 179 sites
Registry title
Therapeutic Equivalence of CHF5993 pMDI 100/6/12.5 µg HFA-152a in Subjects With Mild to Moderate Asthma
Status
Recruiting
Phase
Phase 2
People taking part
780 people, planned
Started
17 Dec 2025
Expected to end
3 Jun 2027
Type of study
Interventional, 3 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • CHF5993 pMDI with HFA-152a
  • CHF5993 pMDI with HFA-134a
  • CHF718 pMDI with HFA-134a
Record updated
25 June 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults aged 18 to 75 with mild to moderate asthma who are already on stable inhaled treatment. It compares two versions of an asthma inhaler.

Age
18 to 75 years
Sex
Men and women
Disease stage
Mild to moderate asthma, diagnosed at least 6 months before screening and before age 50. Asthma must be controlled or partly controlled (ACQ-7 score under 1.5).
Earlier treatment
Must have been on a stable dose for at least 4 weeks of either low or medium dose inhaled corticosteroids (ICS) alone, or ICS plus a long-acting β2-agonist (LABA). High dose ICS, LAMA, and biologic therapy within 6 months cannot be used.
Biomarker or test result
Lung function (FEV1) above 40% and below 90% of the predicted normal value before bronchodilator. FEV1 or forced vital capacity must rise by more than 12% and more than 200 mL within 30 minutes after 400 µg salbutamol.

Main reasons for not taking part

  • Near fatal asthma, or hospital or emergency room care for asthma in the last 6 months
  • Asthma flare needing steroid tablets, emergency room or hospital stay within 3 months
  • Lung diseases other than asthma, lung surgery (resection) or lung cancer
  • Active cancer or a history of cancer
  • Clinically significant heart or blood vessel condition

The registry criteria, word for word

Show all 18 criteriaShow less

Who can take part

  • Male and female adults (18 ≤ age ≤ 75 years) with a diagnosis of Asthma for at least 6 months prior to screening and with diagnosis before the age of 50 years
  • Non-smokers, ex-smokers
  • Body mass index: within the range of 18.0 to 35.0 kg/m2 inclusive
  • Stable asthma therapy: a stable maintenance treatment for at least 4 weeks prior to screening with:; low or medium doses of ICS (Inhaled Corticosteroids) alone; or; low or medium doses of ICS + LABA (Long-acting β2-agonist) (fixed or free combination)
  • Controlled or partly controlled based on an Asthma Control Questionnaire - 7 Items (ACQ-7) score <1.5 at screening and at randomisation
  • Pre-BD (Bronchodilator) FEV1 >40% and <90% of the predicted normal value, after appropriate wash out from BDs, at the Screening Visit (V1)
  • A demonstrated increase in either FEV1 or forced vital capacity of >12% and >200 mL from baseline within 30 minutes (min) after inhalation of 400 µg salbutamol (i.e. albuterol) pMDI at the Screening Visit (V1)

Who cannot take part

  • History of near fatal asthma or hospitalisation for asthma in intensive care unit, inpatient setting or emergency room access for asthma in the previous 6 months prior to screening, which in the judgement of the Investigator may place the subjects at undue risk
  • Recent asthma exacerbation requiring systemic corticosteroids (SCSs), or emergency room admission or hospitalisation within 3 months prior to screening and/or during the run-in period
  • Lung resection
  • Respiratory disorders other than asthma
  • Lower respiratory tract infection
  • Lung cancer and history of lung cancer
  • Subjects with active cancer or a history of cancer (other than lungs)
  • Patients who have clinically significant cardiovascular condition
  • Asthma subjects currently treated with any of the following :; High dose ICS; Long-acting muscarinic antagonist (LAMA); Systemic, depot or slow-release corticosteroids within 12 weeks prior to screening; Any other asthma treatments (e.g. cromolyn sodium, nedocromil sodium, leukotriene modifiers) within 4 weeks prior to screening; Any biologic therapy (e.g. omalizumab, mepolizumab, reslizumab, benralizumab, dupilumab, tezepelumab) within 6 months prior to screening
  • Non-persistent asthma: exercise-induced, seasonal asthma (as the only asthma-related diagnosis) not requiring daily asthma control medicine
  • Run-in compliance: e-Diary completion <75% and run-in treatment compliance <75% at randomisation

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 75 years old?

Where in Bulgaria

Also in 16 other countries, 179 sites

  • Multiprofile Hospital For Active Treatment St. Ivan Rilski Gorna Oriahovitsa EOODGorna Oryahovitsa, BulgariaNo longer taking part
  • Medical Center Pulmo - 2018 EOODHaskovo, BulgariaNo longer taking part
  • Medical Center Zdrave-1 OODKozloduy, BulgariaNo longer taking part
  • Medical Centre Pratia Clinic EOODLovech, BulgariaNo longer taking part
  • Specialized Hospital For Active Treatment Of Pulmonary Diseases Sv.Panteleymon EOODPernik, BulgariaNo longer taking part
  • Multi-profile Hospital for Active Treatment Heart and Brain EADPleven, BulgariaNo longer taking part
  • UNIMED Medical Center EOODPlovdiv, BulgariaNo longer taking part
  • Ambulatoria Za Individualna Praktika Za Specializirana Izvunbolnichna Medicinska Pomost Po Alergologia Doktor Talyat Sali Cholak EOODRazgrad, BulgariaNo longer taking part
  • MC Re Spiro OODRazgrad, BulgariaNo longer taking part
  • Multiprofile Hospital For Active Treatment St. Ivan Rilski Razgrad ADRazgrad, BulgariaNo longer taking part
  • Medical Center Hermes Ruse Ltd.Ruse, BulgariaNo longer taking part
  • Specialized Hospital For Active Treatment Of Pneumo-Phthisiatric Diseases Dr. Dimitar Gramatikov-RuseRuse, BulgariaNo longer taking part
  • MBAL Dr. Ivan Seliminski Sliven ADSliven, BulgariaNo longer taking part
  • University Hospital LozenetzSofia, BulgariaNo longer taking part
  • Medical Center Hera EOODSofiya, BulgariaNo longer taking part
  • Specialized Hospital For Active Treatment Of Pulmonary Diseases Sofia Region EoodSofiya, BulgariaNo longer taking part
  • University First multiprofile hospital for active treatment Sofia St. Joan Krastitel EADSofiya, BulgariaNo longer taking part
  • Medical Center New Rehabilitation Center EOODStara Zagora, BulgariaNo longer taking part
  • Prevencia 2000 MCDMPStara Zagora, BulgariaNo longer taking part
  • Umbal - Prof. D-R Stoyan Kirkovich ADStara Zagora, BulgariaNo longer taking part
  • Medical Centre "Pratia Clinic" EOODVarna, BulgariaNo longer taking part

About the trial

What the trial wants to find out

This study will compare an asthma inhaler that uses a new climate friendly alternative propellant to an asthma inhaler with an existing propellant. We want to make sure both versions of the inhaler work the same way for people with mild to moderate asthma.

The 3 groups in the trial

  • Test Treatment: CHF5993 pMDI (Pressurised Metered Dose Inhaler) with HFA-152aTreatment being tested

    BDP (Beclometasone Dipropionate)/FF (Formoterol Fumarate)/GB (Glycopyrronium Bromide) 100/6/12.5 µg

    Treatment: CHF5993 pMDI with HFA-152a

  • Reference Treatment 1: CHF5993 pMDI with HFA-134aExisting treatment, for comparison

    BDP/FF/GB 100/6/12.5 µg

    Treatment: CHF5993 pMDI with HFA-134a

  • Reference Treatment 2: CHF718 pMDI with HFA-134aExisting treatment, for comparison

    BDP 100 µg

    Treatment: CHF718 pMDI with HFA-134a

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
A Phase II Multinational, Multicentre, Double-blind, Randomised, Active-controlled, 3-way Cross-over Study to Evaluate the Therapeutic Equivalence of CHF5993 pMDI 100/6/12.5 µg HFA-152a Versus CHF5993 pMDI 100/6/12.5 µg HFA-134a in Subjects With Mild to Moderate Asthma
Plain-language title
Comparing two asthma inhalers with different propellants in adultsGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT07301736, who can take part
Record updated
25 June 2026