Therapeutic Equivalence of CHF5993 pMDI 100/6/12.5 µg HFA-152a in Subjects With Mild to Moderate Asthma
Study Identifier:
CLI-05993AA9-01
ClinicalTrials.gov Identifier:
EudraCT Identifier:
N/A
EU CT ID:
Study Contact Information:
Recruiting
Study Details
Medical Condition
- Asthma
Study Drug
- Drug: CHF5993 pMDI with HFA-152a
- Drug: CHF5993 pMDI with HFA-134a
- Drug: CHF718 pMDI with HFA-134a
Date
Dec 2025 - Jun 2027
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18 - 75 Years
Requirements Information
Inclusion and Exclusion 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:
- low or medium doses of ICS (Inhaled Corticosteroids) alone; or
- 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 :
- High dose ICS;
- Long-acting muscarinic antagonist (LAMA);
- Systemic, depot or slow-release corticosteroids within 12 weeks prior to screening;
- Any other asthma treatments (e.g. cromolyn sodium, nedocromil sodium, leukotriene modifiers) within 4 weeks prior to screening;
- 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;
Healthy Volunteers
No
Protocol Summary
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.
Study Locations
Location
Status
Location
Hospital Británico de Buenos Aires_Site n. 032029
Buenos Aires, Argentina, 1275
Status
Recruiting
Location
Centro Medico de Enfermedades Respiratorias_Site n. 032002
Buenos Aires, Argentina, 1602
Status
Recruiting
Location
Centro Medico Respire_Site n. 032014
Buenos Aires, Argentina, 1646
Status
Recruiting
Location
Asociación de Fomento y Sala de Primeros Auxilios "Alberto Mignaburu"_Site n. 032018
Buenos Aires, Argentina, 1887
Status
Recruiting
Location
Centro de Investigaciones Médicas Mar del Plata_Site n. 032019
Buenos Aires, Argentina, 7600
Status
Recruiting
Location
Fundacion CIDEA_Site n. 032009
Buenos Aires, Argentina, C1121ABE
Status
Recruiting
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