Compare a new climate-friendly CHF5993 inhaler to standard inhalers for adults with mild to moderate asthma

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

This trial will see if a CHF5993 inhaler that uses a new climate-friendly propellant works the same and is as safe as standard inhalers for adults with mild to moderate asthma.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 780 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Chiesi Farmaceutici S.p.A. (Industry-sponsored)
• Drugs / interventions: omalizumab, mepolizumab, reslizumab, benralizumab, dupilumab, tezepelumab
• Locations: 1 site (Dagenham)
• Trial ID: NCT07301736 on ClinicalTrials.gov

What this trial studies

This Phase 2 randomized study compares CHF5993 pMDI using a low‑global‑warming propellant (HFA‑152a) with CHF5993 and CHF718 pMDIs using the existing HFA‑134a propellant. Approximately 468 adults (18–75 years) with mild to moderate, stable asthma and documented bronchodilator reversibility will be enrolled across sites in Europe, Latin America, Ukraine, South Africa and the UK. Participants will remain on stable low- or medium-dose ICS therapy (with or without LABA) and will be randomized to one of the inhaler formulations to measure lung function (FEV1), safety, tolerability and asthma control. The goal is to determine whether the HFA‑152a formulation provides equivalent clinical performance and safety to the current propellant formulations while offering lower environmental impact.

Who should consider this trial

Good fit: Adults 18–75 with a diagnosis of asthma before age 50, stable on low or medium dose ICS (with or without LABA), controlled or partly controlled (ACQ‑7 <1.5), pre‑bronchodilator FEV1 between >40% and <90% predicted, and demonstrated bronchodilator reversibility (>12% and >200 mL).

Not a fit: People with severe or uncontrolled asthma, current heavy smokers, those outside the BMI range 18–35 kg/m2, or those who do not meet the lung function and reversibility criteria are unlikely to benefit from participating.

Why it matters

Potential benefit: If successful, patients could use an inhaler that delivers the same asthma control and safety while reducing the inhaler's global warming impact.

How similar studies have performed: Formulation-switch and propellant-equivalence studies for pMDIs have previously shown comparable clinical performance for other agents, but clinical data specifically for HFA‑152a are still limited.

Eligibility 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 this trial is running

Dagenham

• Elpida Trials - Parloes Hub — Dagenham, United Kingdom (Recruiting)

Study contacts

• Principal investigator: Piotr KUNA, MD — Barlicki University Hospital Medical University of Lodz, Poland
• Study coordinator: Chiesi Clinical Trial Info Chiesi Clinical Trials

Conditions Asthma