Safety comparison of two propellants in an inhaler for adults with asthma
Official title: A Randomized, Double-blind, 2-way Crossover, Multicenter Study to Evaluate the Safety of Test Propellant HFA-152a and Reference Propellant HFA-134a When Administered Via Metered Dose Inhalers
Run by GlaxoSmithKline · NCT07645248 · Data updated 2026-11-12
This study tests whether an inhaler with propellant HFA-152a is as safe as the standard HFA-134a propellant in adults with asthma over 4 weeks.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 110 (estimated) |
| Sponsor | GlaxoSmithKline Industry-sponsored |
| Drugs / interventions | mepolizumab, dupilumab, tezepelumab |
| Locations | 20 sites (Aventura, Florida and 19 other locations) |
| Status | Recruiting |
| Started | September 1, 2026 |
| Main results expected | December 28, 2026 |
| Study ends | December 28, 2026 |
| Registry record updated | November 5, 2026 |
| Trial ID | NCT07645248 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18 years and older with a documented history of asthma for at least 6 months who are on stable inhaled therapy for 12 weeks prior to screening.
✕Probably not a fit
Patients who do not experience any safety advantages with the test propellant or who have adverse reactions to either propellant may not see a benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 3 interventional trial compares the safety of two hydrofluoroalkane propellants used in metered dose inhalers for asthma patients. Adults with a documented asthma history for at least 6 months who are on stable asthma therapy will receive either HFA-152a (test) or HFA-134a (reference) for 4 weeks. The study collects safety data on the propellant component while participants continue their usual asthma medications to maintain stability. Primary focus is on safety signals related to bronchospasm and related adverse events in a real-world asthma population.
Why it matters
Potential benefit: If successful, the alternative propellant could offer a safe option for inhaler formulations and support broader access to effective asthma therapies.
How similar studies have gone: Previous propellant comparisons in inhalers have provided important safety data; this study builds on that approach in a controlled setting.
Who can join: the full rules
Show full inclusion / exclusion 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 at screening (and randomization). * Asthma that has remained stable with no severe exacerbations within the last 3 months. * Participants who are current non-smokers, who have not used any inhaled tobacco or vaping products within 12 months of the start of the study, and with a total pack year history of less than equal to (\<=)10 pack. The use of inhaled marijuana, even with a valid prescription, is prohibited within 12 months prior to study start. * Participants who demonstrate ability to use pressurized MDI device in a satisfactory and repeatable manner, as judged visually by the investigator or designee. * Male and female participants are eligible. A female participant is eligible to participate if they are not pregnant or breastfeeding, and one of the following conditions applies: * Is a Participant of nonchildbearing potential (PONCBP) or * Is a Participant of childbearing potential (POCBP) and using a contraceptive method that is highly effective, with a failure rate of \<1%, 30 days prior to and during the study intervention period and for at least 24 hours after the last dose of study intervention. - A POCBP must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations) within 24 hours before the first dose of study intervention in each Treatment Period. * Adults capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the Informed consent form (ICF). Exclusion Criteria: * Participants with a history of life-threatening asthma. * Participants with other significant pulmonary diseases, including (but not limited to): pneumothorax, pulmonary fibrotic disease, bronchopulmonary dysplasia, chronic bronchitis, emphysema, chronic obstructive pulmonary disease, tuberculosis, or other significant respiratory abnormalities other than asthma. * Respiratory Infection: Culture-documented or suspected bacterial or viral infection of the upper or lower respiratory tract, sinus or middle ear that is not resolved within 4 weeks of screening. * Participants with severe asthma exacerbation: Defined as any asthma exacerbation requiring \>=3 days systemic corticosteroids or that resulted in overnight hospitalization or Emergency Department visit requiring additional treatment for asthma within the 3 months prior to screening. * Participants with Other concurrent Diseases/Abnormalities: A participant has any clinically significant, uncontrolled condition or disease state that, in the opinion of the investigator, would put the safety of the participant at risk through study participation or would confound the interpretation of the study results. * Participants with current use of cholinesterase inhibitor medication (e.g. for myasthenia gravis). * Participants with any other prescription or over the counter medication which would significantly affect the course of asthma, or that could interact with sympathomimetic amines. * Participants with Drug or Excipient Allergy: Known or suspected sensitivity to the constituents of salbutamol MDI (e.g. HFA-134a, Oleic acid etc.). * Participants with exposure to more than four new chemical entities within 12 months prior to the first dosing day or participation in a clinical study within 30 days of study start, or 5 half-lives of study drug if that is longer. * Participants with a known or suspected history of alcohol or drug abuse. * Any planned or anticipated changes in asthma medications during the study period. * Any planned environmental changes (e.g. employment changes, travel) which, in the Investigator's opinion, could lead to e.g. increased allergen exposure. * 12-Lead ECG abnormality: Significant abnormality in the 12-lead ECG performed at screening. * Alanine transaminase (ALT) \>2 times Upper limit of normal (ULN). * Total bilirubin \>1.5 times ULN; For participants with Gilbert's syndrome can be included with total bilirubin \>1.5 times ULN if direct bilirubin is \<=1.5 times ULN. * Participants with Cirrhosis or current unstable liver or biliary disease. * Participants with QTc \>480 milliseconds (msec).
Where it's running
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GSK Investigational Site
Aventura, Florida, United States Recruiting -
GSK Investigational Site
Miami, Florida, United States Recruiting -
GSK Investigational Site
Miami, Florida, United States Recruiting -
GSK Investigational Site
Naples, Florida, United States Recruiting -
GSK Investigational Site
Owensboro, Kentucky, United States Recruiting -
GSK Investigational Site
Columbia, Missouri, United States Recruiting
Show 14 more locations
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GSK Investigational Site
Henderson, Nevada, United States Recruiting -
GSK Investigational Site
Medford, Oregon, United States Recruiting -
GSK Investigational Site
Spartanburg, South Carolina, United States Recruiting -
GSK Investigational Site
Spartanburg, South Carolina, United States Recruiting -
GSK Investigational Site
Cypress, Texas, United States Recruiting -
GSK Investigational Site
Tomball, Texas, United States Recruiting -
GSK Investigational Site
Buenos Aires, Argentina Recruiting -
GSK Investigational Site
Ciudad Autonoma de Buenos Aire, Argentina Recruiting -
GSK Investigational Site
Lujan de Cuyo, Argentina Recruiting -
GSK Investigational Site
Ajax, Ontario, Canada Recruiting -
GSK Investigational Site
Québec, Quebec, Canada Recruiting -
GSK Investigational Site
Trois-Rivières, Quebec, Canada Recruiting -
GSK Investigational Site
Great Cambourne, Cambridge, United Kingdom Recruiting -
GSK Investigational Site
Greater Manchester, United Kingdom Recruiting
Study contacts
- Study coordinator: US GSK Clinical Trials Call Center
- Email: GSKClinicalSupportHD@gsk.com
- Phone: 877-379-3718
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.