This is a Phase IIa, multicentre, single dose, randomised, double blind, controlled, 2 way cross-over study to evaluate the potential for bronchoconstriction of the new HFA-152a propellant (single dose) versus the marketed HFA-134a propellant (single dose) in adults with mild asthma. HFA=Hydrofluoroalkane
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
25
Placebo pressurised metered-dose inhaler (pMDI) formulated with the 152a propellant
Placebo pressurised metered-dose inhaler (pMDI) formulated with the 134a propellant
Medicine Evaluation Unit Limited
Manchester, United Kingdom
Safety: Relative Change From Baseline* in Forced Expiratory Volume in 1 s (FEV1) -- 15 Min Post-dose
Safety: Relative change from baseline\* in forced expiratory volume in 1 s (FEV1) at the 15 min post-dose time point. Results are presented as adjusted mean and 95% confidence interval (CI.) The potential of the test propellant (HFA-152a vs HFA-134a) for bronchoconstriction was evaluated using centralised spirometry assessments performed during treatment period 1 (TP1) and treatment period 2 (TP2). T0 was defined as the moment when the first inhalation took place, and was used to calculate the pre-dose time points. T1 was defined as the moment when the last inhalation took place, and was used to calculate the post-dose time points. \*The baseline FEV1 values were the mean of the two pre-dose assessments (i.e., performed at 45 min and 15 min before T0).
Time frame: At 15 min post-dose after T1.
Safety: Safety: Relative Change From Baseline* in FEV1 -- All Other Post-dose Time Points
Safety: Relative change from baseline\* in FEV1 at all the other post-dose time points (5 min, 30 min, 1 h, 1 h 30 min, and 3 h after T1). Results are presented as adjusted mean and 95% CI. The potential of the test propellant (HFA-152a vs HFA-134a) for bronchoconstriction was evaluated using centralised spirometry assessments performed during treatment period 1 (TP1) and treatment period 2 (TP2). T0 was defined as the moment when the first inhalation took place, and was used to calculate the pre-dose time points. T1 was defined as the moment when the last inhalation took place, and was used to calculate the post-dose time points. \*The baseline FEV1 values were the mean of the two pre-dose assessments (i.e., performed at 45 min and 15 min before T0).
Time frame: At 5 min, 30 min, 1 h, 1 h 30 min, and 3 h after T1.
Safety: Absolute Change From Baseline* in FEV1 -- All Time Points Post Dose
Safety: Absolute change from baseline\* in FEV1 at all post-dose time points. Results are presented as adjusted mean and 95% CI. The potential of the test propellant (HFA-152a vs HFA-134a) for bronchoconstriction was evaluated using centralised spirometry assessments performed during treatment period 1 (TP1) and treatment period 2 (TP2). T0 was defined as the moment when the first inhalation took place, and was used to calculate the pre-dose time points. T1 was defined as the moment when the last inhalation took place, and was used to calculate the post-dose time points. The baseline FEV1 values were the mean of the two pre-dose assessments (i.e., performed at 45 min and 15 min before T0).
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Time frame: At 5 min, 15 min, 30 min, 1 h, 1 h 30 min, and 3 h after T1.
Safety: Subjects With a Relative Change From Baseline* in FEV1 <-15% -- All Post-dose Time Points
Safety: Number and percentage of subjects with a relative change from baseline\* in FEV1 at each post-dose time point \<-15%. The baseline FEV1 values were the mean of the two pre-dose assessments (i.e., performed at 45 min and 15 min before T0).
Time frame: At 5 min, 15 min, 30 min, 1 h, 1 h 30 min, and 3 h after T1.
Safety: Change From Baseline* in FEV1 Area Under the Concentration-time Curve From Time Zero to 3 Hours (AUC0-3h)
Change from baseline\* in FEV1 area under the concentration-time curve from time zero to 3 hours (AUC0-3h). Results show the change from baseline in FEV1 AUC(0-3h) corrected for Time, in litres The potential of the test propellant (HFA-152a vs HFA-134a) for bronchoconstriction was evaluated using centralised spirometry assessments performed during treatment period 1 (TP1) and treatment period 2 (TP2). T0 was defined as the moment when the first inhalation took place, and was used to calculate the pre-dose time points. T1 was defined as the moment when the last inhalation took place, and was used to calculate the post-dose time points. \*The baseline FEV1 values were the mean of the two pre-dose assessments (i.e., performed at 45 min and 15 min before T0).
Time frame: At 3 h post-dose.
Safety: Relative Change From Baseline* in Peak Expiratory Flow (PEF) -- All Post-dose Time Points
Safety: Relative change from baseline\* in peak expiratory flow (PEF) at all post-dose time points. The potential of the test propellant (HFA-152a vs HFA-134a) for bronchoconstriction was evaluated using centralised spirometry assessments performed during treatment period 1 (TP1) and treatment period 2 (TP2). T0 was defined as the moment when the first inhalation took place, and was used to calculate the pre-dose time points. T1 was defined as the moment when the last inhalation took place, and was used to calculate the post-dose time points. The baseline PEF values were the mean of the two pre-dose assessments (i.e., performed at 45 min and 15 min before T0).
Time frame: At 5 min, 15 min, 30 min, 1 h, 1 h 30 min, and 3 h after T1.
Safety: Absolute Change From Baseline* in PEF -- All Post-dose Time Points
Safety: Absolute change from baseline\* in PEF at all post-dose time points. The potential of the test propellant (HFA-152a vs HFA-134a) for bronchoconstriction was evaluated using centralised spirometry assessments performed during treatment period 1 (TP1) and treatment period 2 (TP2). T0 was defined as the moment when the first inhalation took place, and was used to calculate the pre-dose time points. T1 was defined as the moment when the last inhalation took place, and was used to calculate the post-dose time points. The baseline PEF values were the mean of the two pre-dose assessments (i.e., performed at 45 min and 15 min before T0).
Time frame: At 5 min, 15 min, 30 min, 1 h, 1 h 30 min, and 3 h after T1.
Safety: Subjects With Use of Rescue Medication -- 3 h Post Dose
Number and percentage of subjects with use of rescue medication in the 3 h post dose.
Time frame: 3 h post-dose.
Safety and Tolerability: Vital Signs -- Diastolic Blood Pressure
Safety and tolerability: Mean change from baseline in the Vital Signs -- Diastolic Blood Pressure
Time frame: At 45 min, 1.75 h, 2.75 h post dose.
Safety and Tolerability: Vital Signs -- Systolic Blood Pressure
Safety and tolerability: Mean change from baseline in the Vital Signs -- Systolic Blood Pressure
Time frame: At 45 min, 1.75 h, 2.75 h post dose.
Safety and Tolerability: ECG Parameter -- Heart Rate
Safety and tolerability: Mean change from baseline in the ECG parameter -- Heart rate
Time frame: At 45 min, 1.75 h, 2.75 h post dose.
Safety and Tolerability: ECG Parameter -- PR Interval
Safety and tolerability: Mean change from baseline in the ECG parameter -- PR interval.
Time frame: At 45 min, 1.75 h, 2.75 h post dose.
Safety and Tolerability: ECG Parameter -- QRS
Safety and tolerability: Mean change from baseline in the ECG parameter -- QRS interval.
Time frame: At 45 min, 1.75 h, 2.75 h post dose.
Safety and Tolerability: ECG Parameter -- QTcF Interval
Safety and tolerability: Mean change from baseline in the ECG parameter -- QTcF interval.
Time frame: At 45 min, 1.75 h, 2.75 h post dose.