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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Hospital Británico de Buenos Aires_Site n. 032029
  Buenos Aires, Argentina Recruiting
• Centro Medico de Enfermedades Respiratorias_Site n. 032002
  Buenos Aires, Argentina Recruiting
• Centro Medico Respire_Site n. 032014
  Buenos Aires, Argentina Recruiting
• Asociación de Fomento y Sala de Primeros Auxilios "Alberto Mignaburu"_Site n. 032018
  Buenos Aires, Argentina Recruiting
• Centro de Investigaciones Médicas Mar del Plata_Site n. 032019
  Buenos Aires, Argentina Recruiting
• Fundacion CIDEA_Site n. 032009
  Buenos Aires, Argentina Recruiting

+117 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Principal investigator: Piotr KUNA, MD — Barlicki University Hospital Medical University of Lodz, Poland
• Study coordinator: Chiesi Clinical Trial Info Chiesi Clinical Trials
• Email: clinicaltrials_info@chiesi.com
• Phone: +39 0521 2791

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.