About this trial
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
This trial does not accept healthy volunteersQualifiers
Participant must be aged greater than equal to (>=)18 years at the time of signing the informed consent.
Documented history of asthma, as defined by Global Initiative for Asthma (GINA)
Short-Acting beta2-Adrenoreceptor Agonists (SABA) as needed (prn) only
Inhaled corticosteroid (ICS)/SABA prn only
Disqualifiers
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.
Trial design
Crossover
Treatments tested in this trial
HFA-152a
DrugHFA-152a will be administered.
HFA-134a
DrugHFA-134a will be administered.
Treatment groups
Trial outcomes
Primary outcomes
Number of participants with adverse events (AEs)
Secondary outcomes
Number of participants with serious adverse events (SAEs)
Absolute values for vital sign parameters: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) (Millimeters of mercury [mmHg])
Absolute values for vital sign parameter: Pulse rate
Change from Baseline in vital sign parameters: SBP and DBP (mmHg)
Sponsors and contacts
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