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Looking for participantsPhase2

Therapeutic Equivalence of CHF5993 pMDI 100/6/12.5 µg HFA-152a in Subjects With Mild to Moderate Asthma

Sponsor: Chiesi Farmaceutici S.p.A.

NCT ID: NCT07301736

View on ClinicalTrials.gov ↗

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.

Asthma

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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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
Inclusion Criteria: * 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: 1. low or medium doses of ICS (Inhaled Corticosteroids) alone; or 2. 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). Exclusion Criteria: * 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 ; * Non-persistent asthma: exercise-induced, seasonal asthma (as the only asthma-related diagnosis) not requiring daily asthma control medicine; * Asthma subjects currently treated with any of the following : 1. High dose ICS; 2. Long-acting muscarinic antagonist (LAMA); 3. Systemic, depot or slow-release corticosteroids within 12 weeks prior to screening; 4. Any other asthma treatments (e.g. cromolyn sodium, nedocromil sodium, leukotriene modifiers) within 4 weeks prior to screening; 5. Any biologic therapy (e.g. omalizumab, mepolizumab, reslizumab, benralizumab, dupilumab, tezepelumab) within 6 months prior to screening; * Respiratory disorders other than asthma * Lung resection; * 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; * Run-in compliance: e-Diary completion \<75% and run-in treatment compliance \<75% at randomisation;

Where Is This Study? (10 UK sites)

Ormeau Clinical Trials Ltd._Site n. 826005

Belfast BT2 8BG, United Kingdom

Recruiting
Site contact (verified)
Damien McNallyPrincipal Investigator

North Bristol NHS Trust - Southmead Hospital Bristol_Site n. 826010

Bristol BS10 5NB, United Kingdom

Recruiting
Site contact (verified)
James DoddPrincipal Investigator

Concord Medical Centre_Site n. 826009

Bristol BS34 6BQ, United Kingdom

Recruiting
Site contact (verified)
James CasePrincipal Investigator

Elpida Trials - Parloes Hub_Site n. 826003

Dagenham RM9 5QP, United Kingdom

Recruiting
Site contact (verified)
Ravali GoriparthiPrincipal Investigator

4 Medical Clinical Solutions (4MCS) - London_Site n. 826004

London IG1 4HP, United Kingdom

Recruiting
Site contact (verified)
Martin PalinPrincipal Investigator

Maidstone and Tunbridge Wells NHS Trust - Maidstone Hospital_Site n. 826008

Maidstone ME16 9QQ, United Kingdom

Recruiting
Site contact (verified)
Tuck-Kay LokePrincipal Investigator

Medicines Evaluation Unit_Site n. 826006

Manchester M23 9QZ, United Kingdom

Recruiting
Site contact (verified)
Dave SinghPrincipal Investigator

Accellacare South London_Site n. 826001

Orpington BR5 3QG, United Kingdom

Recruiting
Site contact (verified)
Njobuenwnu Hyacienth AmahPrincipal Investigator

Portsmouth Hospitals NHS Trust - Queen Alexandra Hospital_Site n. 826002

Portsmouth PO6 3LY, United Kingdom

Recruiting
Site contact (verified)
Thomas BrownPrincipal Investigator

Abbeywell Surgery_Site n. 826007

Romsey SO51 8EN, United Kingdom

Recruiting
Site contact (verified)
Nicola LesterPrincipal Investigator

How to Get in Touch

Chiesi Clinical Trial Info Chiesi Clinical Trials

Sponsor contact

CONTACT

+39 0521 2791 clinicaltrials_info@chiesi.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-06