Recruiting
Therapeutic Equivalence of CHF5993 pMDI 100/6/12.5 µg HFA-152a in Subjects With Mild to Moderate Asthma
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.
ClinicalTrials.gov IDNCT07301736
PhasePHASE2
Enrollment780
SponsorChiesi Farmaceutici S.p.A.
Age18 Years
SexALL
Conditions studied
Asthma
About this study
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.
Interventions
- Drug: CHF5993 pMDI with HFA-152a — two puffs BID (twice daily)
- Drug: CHF5993 pMDI with HFA-134a — two puffs BID
- Drug: CHF718 pMDI with HFA-134a — two puffs BID
Primary outcomes
- Change from baseline in forced expiratory volume in 1 second (FEV1) area under the curve from time zero to 4 hours (AUC0-4h) on Day 1 (Day 1)
- Change from baseline in pre-dose FEV1 on Day 28 (Day 28)
Eligibility information
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;
Study locations
- Hospital Británico de Buenos Aires_Site n. 032029, Buenos Aires, 1275 Argentina
- Centro Medico de Enfermedades Respiratorias_Site n. 032002, Buenos Aires, 1602 Argentina
- Centro Medico Respire_Site n. 032014, Buenos Aires, 1646 Argentina
- Asociación de Fomento y Sala de Primeros Auxilios "Alberto Mignaburu"_Site n. 032018, Buenos Aires, 1887 Argentina
- Centro de Investigaciones Médicas Mar del Plata_Site n. 032019, Buenos Aires, 7600 Argentina
- Fundacion CIDEA_Site n. 032009, Buenos Aires, C1121ABE Argentina
- Centro Medico Arsema_Site n. 032003, Buenos Aires, C1427BCR Argentina
- Centro de Investigaciones Metabólicas (CINME)_Site n. 032025, Ciudad Autonoma de Buenos Aire, 1056ABJ Argentina
- Centro de Medicina Respiratoria - Concepcion del Uruguay_Site n. 032015, Ciudad Autonoma de Buenos Aire, 1056ABJ Argentina
- CARE - Centro de Alergia y Enfermedades Respiratorias_Site n. 032028, Ciudad Autonoma de Buenos Aire, 1414 Argentina
Showing 10 of 167 reported sites. See the official listing for all locations.
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.