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

Recruiting now · Phase 2

Conditions studied: Asthma

In brief

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.

Key facts

Study ID

NCT07301736

Run by

Chiesi Farmaceutici S.p.A.

People needed

780

Starts

2025-12-17

Expected to finish

2027-06-03

Last updated by the study team

2026-06-25

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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;

Where it is running

• Centro Medico de Enfermedades Respiratorias_Site n. 032002 — Buenos Aires, Argentina (enrolling)
• Centro Medico Respire_Site n. 032014 — Buenos Aires, Argentina (enrolling)
• Asociación de Fomento y Sala de Primeros Auxilios "Alberto Mignaburu"_Site n. 032018 — Buenos Aires, Argentina (enrolling)
• Centro de Investigaciones Médicas Mar del Plata_Site n. 032019 — Buenos Aires, Argentina (enrolling)
• Fundacion CIDEA_Site n. 032009 — Buenos Aires, Argentina (enrolling)
• Centro Medico Arsema_Site n. 032003 — Buenos Aires, Argentina (enrolling)
• Centro de Investigaciones Metabólicas (CINME)_Site n. 032025 — Ciudad Autonoma de Buenos Aire, Argentina (enrolling)
• Centro de Medicina Respiratoria - Concepcion del Uruguay_Site n. 032015 — Ciudad Autonoma de Buenos Aire, Argentina (enrolling)
• CARE - Centro de Alergia y Enfermedades Respiratorias_Site n. 032028 — Ciudad Autonoma de Buenos Aire, Argentina (enrolling)
• Consultorio Medico Dra. Rivera_Site n. 032012 — Ciudad Autonoma de Buenos Aire, Argentina (enrolling)
• Fundación Respirar Salud_Site n. 032004 — Ciudad Autonoma de Buenos Aire, Argentina (enrolling)
• Instituto de Medicina Respiratoria (IMER) - Cordoba_Site n. 032023 — Córdoba, Argentina (enrolling)
• CePIR_Site n. 032021 — La Plata, Argentina (enrolling)
• Fundacion Scherbovsky_Site n. 032013 — Mendoza, Argentina (enrolling)
• Instituto Medico INSARES SA_Site n. 032005 — Mendoza, Argentina (enrolling)
• Cimro Consultorios Medicos - Centro de Investigacion_Site n. 032006 — Mendoza, Argentina (enrolling)
• Centro Respiratorio Quilmes_Site n. 032007 — Quilmes, Argentina (enrolling)
• Fundacion Innovaciencia_Site n. 032017 — Rosario, Argentina (enrolling)
• Instituto de Especialidades de la Salud Rosario_Site n. 032020 — Rosario, Argentina (enrolling)
• Instituto Medico de la Fundacion de Estudios Clínicos_Site n. 032001 — Rosario, Argentina (enrolling)
• Fundacion Grupo Colaborativo Rosario_Site n. 032010 — Rosario, Argentina (enrolling)
• Instituto De Enfermedades Respiratorias E Investigacion Medica (IERIM)_Site n. 032011 — San Juan Bautista, Argentina (enrolling)
• Centro Modelo de Cardiologia SRL_Site n. 032016 — San Miguel de Tucumán, Argentina (enrolling)
• Clinica Mayo de UMCB SRL_Site n. 032026 — San Miguel de Tucumán, Argentina (enrolling)
• Hospital Británico de Buenos Aires_Site n. 032029 — Buenos Aires, Argentina (enrolling)

Full record on ClinicalTrials.gov

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