ClinicaliQ Trial Snapshot
- 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) — Recruiting • Phase III • Respiratory / COPD / Asthma • NCT07645248.
- What is being tested: Safety comparison of two propellant formulations in metered dose inhalers (MDIs) over 4 weeks exposure—HFA-152a (test propellant) versus HFA-134a (established reference propellant)—to generate additional safety data on the propellant component of reformulated inhaled products.
- Patient eligibility overview: Study participants include patients requiring regular inhaled medication via MDI who can tolerate 4 weeks of controlled propellant exposure; specific inclusion/exclusion criteria would typically assess baseline respiratory function, stability of condition, and ability to comply with study protocol requirements.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
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).
Eligibility Snapshot
- : * 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…
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.