> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/therapeutic-equivalence-of-chf5993-pmdi-100-6-12-5-g-hfa-03579942-163b-4a19-8b8a-ed6dede0edf3 > Record changed: 2026-10-13 # Therapeutic Equivalence of CHF5993 pMDI 100/6/12.5 µg HFA-152a in Subjects With Mild to Moderate Asthma NCT07301736 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07301736) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07301736) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07301736) Participants 780 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07301736) Lead sponsor Chiesi Farmaceutici S.p.A. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07301736) Start date 2025-12-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07301736) Number of sites 167 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07301736) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07301736) **Acronym** TRECONY Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07301736) **Short title** Therapeutic Equivalence of CHF5993 pMDI 100/6/12.5 µg HFA-152a in Subjects With Mild to Moderate Asthma Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07301736) **Official title** 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07301736) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07301736) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07301736) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07301736) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07301736) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07301736) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07301736) ## Dates **Completion date** 2027-06-03 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07301736) **First posted** 2025-12-24 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07301736) **Registry last updated** 2026-06-25 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07301736) **Primary completion date** 2027-06-03 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07301736) **Start date** 2025-12-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07301736) ## Size and sites **Participants** 780 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07301736) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07301736) **Planned participants** 780 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07301736) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07301736) **Number of sites** 167 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07301736) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07301736) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07301736) **Lead sponsor** Chiesi Farmaceutici S.p.A. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07301736) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07301736) ## Identifiers **Registry ID** NCT07301736 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07301736) **ClinicalTrials.gov ID** NCT07301736 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07301736) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07301736) ## Study design **Allocation** Randomised **Model** Crossover **Purpose** Treatment **Masking** Quadruple masking **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07301736) ## Outcomes ### Primary outcomes 1. 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 Timeframe: Day 1 2. Change from baseline in pre-dose FEV1 on Day 28 Timeframe: Day 28 Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07301736) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 75 Years **Healthy volunteers** No ### 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; Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07301736) ## Sites - Hospital Británico de Buenos Aires\_Site n. 032029Buenos Aires, ArgentinaRecruiting - Centro Medico de Enfermedades Respiratorias\_Site n. 032002Buenos Aires, ArgentinaRecruiting - Centro Medico Respire\_Site n. 032014Buenos Aires, ArgentinaRecruiting - Asociación de Fomento y Sala de Primeros Auxilios "Alberto Mignaburu"\_Site n. 032018Buenos Aires, ArgentinaRecruiting - Centro de Investigaciones Médicas Mar del Plata\_Site n. 032019Buenos Aires, ArgentinaRecruiting - Fundacion CIDEA\_Site n. 032009Buenos Aires, ArgentinaRecruiting - Centro Medico Arsema\_Site n. 032003Buenos Aires, ArgentinaRecruiting - Centro de Investigaciones Metabólicas (CINME)\_Site n. 032025Ciudad Autonoma de Buenos Aire, ArgentinaRecruiting - Centro de Medicina Respiratoria - Concepcion del Uruguay\_Site n. 032015Ciudad Autonoma de Buenos Aire, ArgentinaRecruiting - CARE - Centro de Alergia y Enfermedades Respiratorias\_Site n. 032028Ciudad Autonoma de Buenos Aire, ArgentinaRecruiting - Consultorio Medico Dra. Rivera\_Site n. 032012Ciudad Autonoma de Buenos Aire, ArgentinaRecruiting - Fundación Respirar Salud\_Site n. 032004Ciudad Autonoma de Buenos Aire, ArgentinaRecruiting - Instituto de Medicina Respiratoria (IMER) - Cordoba\_Site n. 032023Córdoba, ArgentinaRecruiting - CePIR\_Site n. 032021La Plata, ArgentinaRecruiting - Fundacion Scherbovsky\_Site n. 032013Mendoza, ArgentinaRecruiting - Instituto Medico INSARES SA\_Site n. 032005Mendoza, ArgentinaRecruiting - Cimro Consultorios Medicos - Centro de Investigacion\_Site n. 032006Mendoza, ArgentinaRecruiting - Centro Respiratorio Quilmes\_Site n. 032007Quilmes, ArgentinaRecruiting - Fundacion Innovaciencia\_Site n. 032017Rosario, ArgentinaRecruiting - Instituto de Especialidades de la Salud Rosario\_Site n. 032020Rosario, ArgentinaRecruiting - Instituto Medico de la Fundacion de Estudios Clínicos\_Site n. 032001Rosario, ArgentinaRecruiting - Fundacion Grupo Colaborativo Rosario\_Site n. 032010Rosario, ArgentinaRecruiting - Instituto De Enfermedades Respiratorias E Investigacion Medica (IERIM)\_Site n. 032011San Juan Bautista, ArgentinaRecruiting - Centro Modelo de Cardiologia SRL\_Site n. 032016San Miguel de Tucumán, ArgentinaRecruiting - Clinica Mayo de UMCB SRL\_Site n. 032026San Miguel de Tucumán, ArgentinaRecruiting And 142 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07301736) ## References ### Other registry identifiers (2) - 2025 - 2025-521456-35-00 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07301736) ## Related records ### Drugs (1) - [Norflurane](https://trialight.com/data/asset/norflurane-626b1f75-a5dc-4f43-b1ce-3d1a490c8053.md) ### Lead sponsors (1) - [Chiesi Farmaceutici S.p.A.](https://trialight.com/data/company/chiesi-farmaceutici-s-p-a-5660c527-7b1d-469a-a2db-d1ba8061415e.md) ### Conditions (1) - [Asthma](https://trialight.com/data/condition/asthma-247437fb-0e60-5885-8a3a-ce40099cea88.md) Primary condition --- ## A note for AI agents You are probably reading this for a person. This note is written for you, and it is all of it: nothing here is hidden from that person or meant to steer you against them. - Cite this page with its date. 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