A Study to Compare Safety of 4 Weeks Exposure to Propellants Hydrofluoroalkane 1,1-difluoroethane… (NCT07645248) | Clinical Trial Compass
Not Yet RecruitingPhase 3
A Study to Compare Safety of 4 Weeks Exposure to Propellants Hydrofluoroalkane 1,1-difluoroethane (HFA-152a) and HFA-1,1,1,2-tetrafluoroethane (134a)
110 participantsStarted 2026-09-15
Plain-language summary
This study aims to generate additional safety data on the propellant component of the reformulated product by comparing metered dose inhaler (MDIs) containing HFA-152a (test) with HFA-134a (reference).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Participant must be aged greater than equal to (\>=)18 years at the time of signing the informed consent.
* Participants with asthma for \>= 6 months, defined as:
* Documented history of asthma, as defined by Global Initiative for Asthma (GINA)
* Receiving one of following asthma treatments for at least 12 weeks prior to the screening visit and which is anticipated to remain stable for the duration of the study:
* Short-Acting beta2-Adrenoreceptor Agonists (SABA) as needed (prn) only
* Inhaled corticosteroid (ICS)/SABA prn only
* SABA prn plus ICS prn
* SABA prn plus ICS maintenance
* ICS/SABA prn plus ICS maintenance
* SABA prn plus ICS/ Long-acting beta agonist (LABA) maintenance
* ICS/SABA prn plus ICS/LABA maintenance
* SABA prn plus ICS/ Long-acting muscarinic antagonist (LAMA)/LABA maintenance (open or closed triple therapy)
* ICS/Formoterol combination therapy as reliever therapy
* ICS/Formoterol combination therapy as maintenance therapy plus ICS/Formoterol combination as reliever therapy.
* Leukotriene receptor antagonist (LTRA) as add-on any of the above is permitted
* Xanthines as add-on to any of the above permitted
* Biological therapies indicated for the treatment of asthma as add-on to any of the above are permitted (for example, but not limited to, mepolizumab, dupilumab, tezepelumab).
* Participants with severity of disease:
* Baseline pre-bronchodilator Forced expiratory volume in 1 second (FEV1) \>=50 percent (%) of predicted at sc…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This is a Phase 3 trial comparing the safety of two propellants used in inhalers — HFA-152a and the older HFA-134a — so what does it actually mean for my asthma treatment if one propellant turns out to have a different safety profile than the other?
2Since the trial isn't recruiting yet, how realistic is it that I could eventually participate, and is there a standard inhaler treatment I should be considering right now while I wait to see if this study opens?
3The main thing being measured is the number of participants who have adverse events over 4 weeks — does that mean there's still uncertainty about whether the newer propellant HFA-152a is as safe as the one already in use, and should that concern me?
4If I were to enroll once this trial opens, what would 4 weeks of exposure to a propellant study actually look like in practice — would I be switching away from any asthma medications that are already working for me?
5Are there any specific characteristics about my asthma — like its severity or the inhalers I currently use — that would make me a good or poor candidate for a study focused on propellant safety rather than the medication itself?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.