RecruitingAsthma
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)
Eligible age
18+ yrs
Accepts
All genders
Locations
7 states
Healthy volunteers
No
See if you qualify for this study
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About this study
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).
Sponsor: GlaxoSmithKline
You may qualify if…
- ✓ 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
You may not qualify if…
- ✕ 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.).
Where it's recruiting
Source: ClinicalTrials.gov · NCT07645248 · last updated 2026-09-25