The primary objectives of the study are: Part 1: to characterize the potency and variability of dose response on efficacy (Provocative concentration of methacholine causing at least a 20% fall in forced expiratory volume (FEV1) \[PC20\]) of salbutamol administered via MDI with salbutamol HFA-134a or salbutamol HFA-152a in participants with mild asthma. Part 2: to compare the comparative dose response on efficacy (PC20) of salbutamol when administered via MDI with salbutamol HFA-134a or salbutamol HFA-152a in participants with mild asthma.
Male or female; females may be of childbearing potential, of nonchildbearing potential, or postmenopausal.
Participant must be 18 to 65 years of age inclusive, at the time of screening.
≥50 kg, at the time of screening.
Body mass index (BMI) with 19.0-35.0 kg/m2 inclusive, at the time of screening.
Medical Conditions
A history of life-threatening asthma or asthma that is unstable in the opinion of the investigator.
A history of respiratory diseases to include (but not limited to): pneumothorax, pulmonary fibrotic disease, bronchopulmonary dysplasia, chronic bronchitis, cystic fibrosis, bronchiectasis, interstitial lung disease, emphysema, chronic obstructive pulmonary disease, tuberculosis, or other respiratory abnormalities other than asthma.
Asymptomatic gallstones.
Crossover
Salbutamol HFA-152a
DrugA single 100, 200 or 400 μg dose, given as 1, 2 or 4 × 100 μg actuations (exvalve) at 20 second intervals.
Salbutamol HFA-134a
DrugA single 100, 200 or 400 μg dose, given as 1, 2 or 4 × 100 μg actuations (exvalve) at 20 second intervals.
Placebo
DrugA single placebo HFA-152a suspension or placebo HFA-134a suspension dose, given as at 20 second intervals.
Part 1 & Part 2: Provocative concentration of methacholine causing at least a 20% fall in FEV1 (PC20)
Part 1 & Part 2: Peak QTc Interval
Part 1 & Part 2: Peak Heart Rate (HR)
Part 1 & Part 2: Minimum Serum Potassium
Part 1: Maximum Observed Plasma Concentration (Cmax)
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