At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- CHF5993 pMDI with HFA-152a (drug), CHF5993 pMDI with HFA-134a (drug), CHF718 pMDI with HFA-134a (drug)
- How long the study runs
- Study runs about 18 months (dates as stated)
- About the drug or intervention
- CHF5993 pMDI with HFA-152a — drug: two puffs BID (twice daily) · CHF5993 pMDI with HFA-134a — drug: two puffs BID · CHF718 pMDI with HFA-134a — drug: two puffs BID
- Patient visit burden
- Not specified by the sponsor
In plain English
This study looks at whether a new inhaler called CHF5993 (a pressurised metered-dose inhaler, or pMDI, containing 100/6/12.5 micrograms of medicine) works in the same way as an existing treatment for adults with mild to moderate asthma. It is funded by Chiesi Farmaceutici S.p.A. The study uses a newer type of propellant called HFA-152a.
Who can take part
- Adults aged 18 to 75, male or female, diagnosed with asthma at least 6 months ago and before the age of 50
- Non-smokers or ex-smokers
- Body mass index (BMI) between 18.0 and 35.0
- On a stable asthma treatment for at least 4 weeks before screening: low or medium dose inhaled corticosteroids (ICS), alone or with a long-acting beta-agonist (LABA)
- Asthma that is controlled or partly controlled, based on a questionnaire score (ACQ-7) below 1.5 at screening and randomisation
- Breathing test results within a set range, and lungs that respond to a reliever inhaler (salbutamol) shown by an improvement on a breathing test
Who may not be able to
- A history of near-fatal asthma, or a hospital, intensive care, or emergency room visit for asthma in the previous 6 months
- An asthma flare-up needing steroid tablets, emergency care, or hospital stay within 3 months before screening or during the run-in period
- Asthma that only happens with exercise or seasonally and does not need daily medicine
- Current treatment with high-dose inhaled corticosteroids (ICS), long-acting muscarinic antagonists (LAMA), steroid tablets or injections in the last 12 weeks, certain other asthma medicines in the last 4 weeks, or biologic medicines in the last 6 months
- Other breathing conditions, lung surgery, chest infection, lung cancer, or other cancers (current or past)
- Serious heart problems
- Not completing the study diary or taking the run-in treatment as asked (below 75%)
What taking part involves
- • Using the CHF5993 inhaler (100/6/12.5 micrograms) with the new HFA-152a propellant
- • Keeping an electronic diary and taking study treatment as instructed during the run-in period
- • Breathing tests, including one after inhaling salbutamol (a reliever inhaler)
Time commitment: Number of visits and total study duration: Not stated — ask the trial team; taking part involves breathing tests, keeping an e-diary, and using study inhalers.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 18 Years to 75 Years
- Who
- All
- Number of participants
- 780
- Started
- 2025-12-17
- Last checked
- 2026-06
Plain English Summary
What is this study?
- • Testing a new treatment for asthma
- • Phase2 - 780 participants
- • This study will compare an asthma inhaler that uses a new climate friendly alternative propellant to an asthma inhaler with an existing propellant
Who can take part?
- • Ages 18 Years to 75 Years
- • Diagnosed with asthma
Where?
- • Belfast - Ormeau Clinical Trials Ltd._Site n. 826005
- • Bristol - North Bristol NHS Trust - Southmead Hospital Bristol_Site n. 826010
- • Bristol - Concord Medical Centre_Site n. 826009
- • Dagenham - Elpida Trials - Parloes Hub_Site n. 826003
- • +6 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
More detail
This global study aims to compare whether the investigational inhaler with the new HFA-152a propellant is as safe, effective and well tolerated in patients with asthma as the inhalers that use the existing HFA-134a propellant. HFA-152a is a propellant gas that is designed to have a lower global warming potential and to be more climate friendly. The study will be conducted in Europe, Latin America, Ukraine, South Africa and United Kingdom. It is planned to randomize 468 patients.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years - 75 Years
- Who can join: All genders
What the study is looking for
- ✓Male and female adults (18 ≤ age ≤ 75 years) with a diagnosis of Asthma for at least 6 months prior to screening and...
- ✓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
Who cannot take part
- ✗Recent asthma exacerbation requiring systemic corticosteroids (SCSs), or emergency room admission or hospitalisation...
- ✗Non-persistent asthma: exercise-induced, seasonal asthma (as the only asthma-related diagnosis) not requiring daily...
- ✗Asthma subjects currently treated with any of the following :
- ✗High dose ICS;
- ✗Long-acting muscarinic antagonist (LAMA);
See the full criteria
Where Is This Study? (10 UK sites)
Ormeau Clinical Trials Ltd._Site n. 826005
Belfast BT2 8BG, United Kingdom
North Bristol NHS Trust - Southmead Hospital Bristol_Site n. 826010
Bristol BS10 5NB, United Kingdom
Concord Medical Centre_Site n. 826009
Bristol BS34 6BQ, United Kingdom
Elpida Trials - Parloes Hub_Site n. 826003
Dagenham RM9 5QP, United Kingdom
4 Medical Clinical Solutions (4MCS) - London_Site n. 826004
London IG1 4HP, United Kingdom
Maidstone and Tunbridge Wells NHS Trust - Maidstone Hospital_Site n. 826008
Maidstone ME16 9QQ, United Kingdom
Medicines Evaluation Unit_Site n. 826006
Manchester M23 9QZ, United Kingdom
Accellacare South London_Site n. 826001
Orpington BR5 3QG, United Kingdom
Portsmouth Hospitals NHS Trust - Queen Alexandra Hospital_Site n. 826002
Portsmouth PO6 3LY, United Kingdom
Abbeywell Surgery_Site n. 826007
Romsey SO51 8EN, United Kingdom
How to Get in Touch
Chiesi Clinical Trial Info Chiesi Clinical Trials
Sponsor contactCONTACT
