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About
The goal of this study is to assess and compare the safety and tolerability of salbutamol administered via metered dose inhaler (MDI) containing propellant 1,1-difluoroethane (HFA-152a) or 1,1,1,2-tetrafluoroethane (HFA-134a) in participants aged >=18 years with asthma
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Inclusion criteria
Participant of ≥18 years of age at the time of signing the informed consent or written informed consent is obtained from each study participant's legal guardian.
Asthma for ≥ 6 months, defined as:
Documented history of asthma, as defined by Global Initiative for Asthma (GINA) (GINA, 2023]
Receiving one of the following asthma treatments, at a stable dose (applicable to daily Inhaled corticosteroid (ICS), ICS/Long-acting bronchodilator (LABA), and ICS/LABA/Long-acting muscarinic antagonist [LAMA]), for at least 12 weeks prior to the screening visit, with treatment that is anticipated to remain stable for the duration of the study:
Severity of disease assessed by the investigator by baseline pre-bronchodilator Forced expiratory volume in 1 second (FEV1)
Asthma Control Status
Asthma Control Questionnaire (ACQ) 6 score <1.5 at screening
Asthma that has remained stable with no severe exacerbations in the last 6 months. Severe exacerbation defined as:
Evidence of reversibility of disease: Airway reversibility is defined as ≥12 percent (%) and ≥200 milliliter (mL) increase in FEV1 within 20 to 60 minutes following up to 4 inhalations of albuterol/salbutamol aerosol.
Participants on as-needed SABA only, or daily maintenance ICS (plus as needed SABA):
With a documented history of reversibility (as defined above) within 2 years will meet this inclusion criterion. Pre- and post-bronchodilator measurements will still be collected at screening to characterize the degree of reversibility.
Who do not have a documented history of reversibility within the past 2 years will need to demonstrate reversibility during the screening period.
Participants on daily maintenance ICS/LABA or ICS/LABA/LAMA:
Do not need to demonstrate reversibility in accordance with the above definition during the screening period. A reversibility maneuver will be performed to characterize the degree of post-bronchodilator change.
Participants should be able to withhold SABA for ≥6 hours and LABA-/ LAMA containing medications for ≥24 hours for the purposes of performing screening spirometry.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
412 participants in 2 patient groups
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Central trial contact
EU GSK Clinical Trials Call Center; US GSK Clinical Trials Call Center
Data sourced from clinicaltrials.gov
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