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NCT07645248
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)
Conditions: Asthma
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 110
Sponsor: GlaxoSmithKline
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).
Eligibility Criteria
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 screening.
* Asthma Control Status
* Asthma Control Questionnaire (ACQ)-6 score less than (\1.5 times ULN if direct bilirubin is \480 milliseconds (msec).
Source: ClinicalTrials.gov (NCT07645248). StuddyBuddy aggregates publicly available trial information.