The purpose of the study is to assess the propellants,1 - Difluoroethane \[HFA-152a\] (Test) and 1,1,1,2-Tetrafluoroethane \[HFA-134a\] (Reference) for their potential to cause the airways to tighten when delivered through pressurized metered dose inhalers (pMDI). The rationale for this study is to develop a low carbon footprint alternative propellant, HFA-152a, which will have a lower impact on global warming.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
20
HFA-152A propellant is administered via oral inhalation
HFA-134A propellant is administered via oral inhalation
GSK Investigational Site
Marlton, New Jersey, United States
GSK Investigational Site
Huntersville, North Carolina, United States
GSK Investigational Site
San Antonio, Texas, United States
Percentage Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at 15 Minutes Post-dose
FEV1 is defined as the volume of air that can be forced out in one second, after taking a deep breath and measured using spirometry. Baseline is defined as the latest pre-dose assessment with a non-missing value including those from unscheduled visits.
Time frame: Baseline (Day 1, pre-dose) and at 15 minutes post-dose
Area Under the Curve for FEV1 From Time Zero to 15 Minutes (FEV1 AUC0-15 Mins)
FEV1 was measured using spirometry. AUC was assessed from the first non-missing timepoint to the 15 minute time point.
Time frame: Up to 15 minutes post-dose
Percentage Change From Baseline in FEV1 at 5, 60, and 180 Minutes Post-dose
FEV1 is defined as the volume of air that can be forced out in one second, after taking a deep breath and measured using spirometry. Baseline is defined as the latest pre-dose assessment with a non-missing value including those from unscheduled visits.
Time frame: Baseline (Day 1, pre-dose) and at 5, 60, and 180 minutes post-dose
Number of Participants With Percentage Change From Baseline in FEV1 <-15% at Timepoints 5, 15, 60 and 180 Minutes Post-dose
FEV1 is defined as the volume of air that can be forced out in one second, after taking a deep breath and using spirometry. Baseline is defined as the latest pre-dose assessment with a non-missing value including those from unscheduled visits.
Time frame: Baseline (Day 1, pre-dose) and at 5, 15, 60 and 180 minutes post-dose
Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs)
An AE is defined as any untoward medical occurrence in a clinical study participant that was temporally associated with the use of a study intervention, regardless of whether it was related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose, resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability or incapacity, or was a congenital anomaly, birth defect, or abnormal pregnancy outcome. SAEs are a subset of AEs. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) coding system.
Time frame: Up to approximately 85 days
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