Comparing two asthma inhalers with different propellants in adults
Tests whether a new-propellant asthma inhaler works like the current one in adults.
Plain-language title generated from the registry record
Registry title: Therapeutic Equivalence of CHF5993 pMDI 100/6/12.5 µg HFA-152a in Subjects With Mild to Moderate Asthma
Key facts
- Where
- Bellville, Benoni, Bloemfontein, Cape Town, Chatsworth, Durban, George, KwaZulu, Middelburg, Pretoria, and Welkom, South AfricaSee the 13 sites
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT07301736, who can take part
Where in South Africa
- Tiervlei Trial CentreBellville, South AfricaTaking people
- Worthwhile Clinical TrialsBenoni, South AfricaTaking people
- IATROS InternationalBloemfontein, South AfricaTaking people
- Task Applied Science (TASK) - Central LocationCape Town, South AfricaTaking people
- Precise Clinical SolutionsChatsworth, South AfricaTaking people
- Synapta Clinical Research CentreDurban, South AfricaTaking people
- TASK EdenGeorge, South AfricaTaking people
- MeditrialKwaZulu, South AfricaTaking people
- Mzansi Ethical Research Centre (MERC)Middelburg, South AfricaTaking people
- Botho Ke Bontle Healthcare Pty LTDPretoria, South AfricaTaking people
- Global Clinical Trials Pty LtdPretoria, South AfricaTaking people
- Johese Clinical Research - Centurion_Site 710010Pretoria, South AfricaTaking people
- Welkom Clinical Trial CentreWelkom, South AfricaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Chiesi Farmaceutici S.p.A.
- Trial code
- NCT07301736EU 2025-521456-35-00
- Record updated
- 25 June 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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: 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 ; Lung resection; Respiratory disorders other than asthma; 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; 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; Non-persistent asthma: exercise-induced, seasonal asthma (as the only asthma-related diagnosis) not requiring daily asthma control medicine; Run-in compliance: e-Diary completion <75% and run-in treatment compliance <75% at randomisation.