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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
84
A single 100, 200 or 400 μg dose, given as 1, 2 or 4 × 100 μg actuations (exvalve) at 20 second intervals.
A single 100, 200 or 400 μg dose, given as 1, 2 or 4 × 100 μg actuations (exvalve) at 20 second intervals.
A single placebo HFA-152a suspension or placebo HFA-134a suspension dose, given as at 20 second intervals.
GSK Investigational Site
Manchester, United Kingdom
RECRUITINGProvocative concentration of methacholine causing at least a 20% fall in FEV1 (PC20)
Time frame: Up to 11 weeks
Peak QTc Interval
Time frame: Up to 11 weeks
Peak Heart Rate (HR)
Time frame: Up to 11 weeks
Minimum Serum Potassium
Time frame: Up to 11 weeks
Maximum Observed Plasma Concentration (Cmax)
Time frame: Up to 11 weeks
Time to Reach Cmax (Tmax)
Time frame: Up to 11 weeks
Area Under the Plasma Concentration-time Curve up to Last Time With Concentrations Above the Lower Limit of Quantification (LLOQ) (AUC[0-last])
Time frame: Up to 11 weeks
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Up to 11 weeks
Absolute Values for 12-lead Electrocardiogram (ECG) Recording of HR
Time frame: Up to 11 weeks
Absolute Values for 12-lead ECGs Recording of Intervals
Intervals recorded: - PR. - QRS. - QT. - QTc
Time frame: Up to 11 weeks
Change from Baseline for Post-dose 12-lead ECGs Recording of HR
The 3 predose measures will be recorded and will be averaged for HR to derive 1 baseline value.
Time frame: Baseline and up to 11 weeks
Change from Baseline for Post-dose 12-lead ECGs Recording of Intervals
The 3 predose measures will be recorded and will be averaged for QTc interval to derive 1 baseline value. Intervals recorded: - PR. - QRS. - QT. - QTc
Time frame: Up to 11 weeks
Number of Participants with Clinically Significant Changes in Clinical Laboratory Parameters
Time frame: Up to 11 weeks
Absolute Values of Vital Signs (Systolic and Diastolic Blood Pressure)
Time frame: Up to 11 weeks
Absolute Values of Vital Signs (Pulse Rate)
Time frame: Up to 11 weeks
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