Trial Outcomes & Findings for A Study to Compare the Effects of Two Propellants in Adults With Mild Asthma (NCT NCT05472662)
NCT ID: NCT05472662
Last Updated: 2024-10-15
Results Overview
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).
COMPLETED
PHASE2
25 participants
At 15 min post-dose after T1.
2024-10-15
Participant Flow
Participant milestones
| Measure |
HFA-152a Followed by HFA-134a
HFA-152a and HFA-134a propellant via pressurised metered-dose inhaler (pMDI):
Administration: Single-dose administration.
Placebo HFA-152a and Placebo HFA-134a: Placebo pMDI formulated with the propellant HFA-152a/ HFA-134a.
In this study arm, HFA-152a was used during period 1 and HFA-134a was used during period 2.
|
HFA-134a Followed by HFA-152a
HFA-134a and HFA-152a propellant via pressurised metered-dose inhaler (pMDI):
Administration: Single-dose administration.
Placebo HFA-134a and Placebo HFA-152a: Placebo pMDI formulated with the propellant HFA-134a/HFA-152a.
In this study arm, HFA-134a was used during period 1 and HFA-152a was used during period 2.
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
11
|
|
Overall Study
COMPLETED
|
14
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
This item presents data on the time since the last exacerbation (in months) and takes into account duration of longer than 12 months since the last exacerbation. Only participants with available date of the last exacerbation were considered.
Baseline characteristics by cohort
| Measure |
HFA-152a Followed by HFA-134a
n=14 Participants
HFA-152a and HFA-134a propellant via pressurised metered-dose inhaler (pMDI):
Administration: Single-dose administration.
Placebo HFA-152a and Placebo HFA-134a: Placebo pMDI formulated with the propellant HFA-152a/ HFA-134a.
In this study arm, HFA-152a was used during period 1 and HFA-134a was used during period 2.
|
HFA-134a Followed by HFA-152a
n=11 Participants
HFA-134a and HFA-152a propellant via pressurised metered-dose inhaler (pMDI):
Administration: Single-dose administration.
Placebo HFA-134a and Placebo HFA-152a: Placebo pMDI formulated with the propellant HFA-134a/HFA-152a.
In this study arm, HFA-134a was used during period 1 and HFA-152a was used during period 2.
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=14 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=25 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=14 Participants
|
11 Participants
n=11 Participants
|
23 Participants
n=25 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=14 Participants
|
0 Participants
n=11 Participants
|
2 Participants
n=25 Participants
|
|
Age, Continuous
|
44.5 years
STANDARD_DEVIATION 16.1 • n=14 Participants
|
38.9 years
STANDARD_DEVIATION 13.3 • n=11 Participants
|
42.0 years
STANDARD_DEVIATION 14.9 • n=25 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=14 Participants
|
5 Participants
n=11 Participants
|
10 Participants
n=25 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=14 Participants
|
6 Participants
n=11 Participants
|
15 Participants
n=25 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=14 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=25 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=14 Participants
|
1 Participants
n=11 Participants
|
2 Participants
n=25 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=14 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=25 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=14 Participants
|
0 Participants
n=11 Participants
|
2 Participants
n=25 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=14 Participants
|
9 Participants
n=11 Participants
|
20 Participants
n=25 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=14 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=25 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=14 Participants
|
1 Participants
n=11 Participants
|
1 Participants
n=25 Participants
|
|
Region of Enrollment
United Kingdom
|
14 participants
n=14 Participants
|
11 participants
n=11 Participants
|
25 participants
n=25 Participants
|
|
Height
|
171.22 cm
STANDARD_DEVIATION 7.82 • n=14 Participants
|
171.70 cm
STANDARD_DEVIATION 8.34 • n=11 Participants
|
171.43 cm
STANDARD_DEVIATION 7.89 • n=25 Participants
|
|
Weight
|
84.25 kg
STANDARD_DEVIATION 13.34 • n=14 Participants
|
77.11 kg
STANDARD_DEVIATION 10.47 • n=11 Participants
|
81.11 kg
STANDARD_DEVIATION 12.46 • n=25 Participants
|
|
Body mass index
|
28.74 kg/m^2
STANDARD_DEVIATION 4.22 • n=14 Participants
|
26.17 kg/m^2
STANDARD_DEVIATION 3.08 • n=11 Participants
|
27.61 kg/m^2
STANDARD_DEVIATION 3.91 • n=25 Participants
|
|
Smoking status at screening
Non-smoker
|
12 Participants
n=14 Participants
|
7 Participants
n=11 Participants
|
19 Participants
n=25 Participants
|
|
Smoking status at screening
Ex-smoker
|
2 Participants
n=14 Participants
|
4 Participants
n=11 Participants
|
6 Participants
n=25 Participants
|
|
Duration of smoking
|
3.5 years
n=14 Participants
|
5.3 years
n=11 Participants
|
4.7 years
n=25 Participants
|
|
Number of pack-years
|
2.00 pack-years
n=14 Participants
|
1.58 pack-years
n=11 Participants
|
1.72 pack-years
n=25 Participants
|
|
Time since first asthma diagnosis
|
33.50 years
n=14 Participants
|
29.41 years
n=11 Participants
|
31.70 years
n=25 Participants
|
|
Asthma medication at study entry
As needed short-acting β2-agonists (SABA)
|
12 Participants
n=14 Participants
|
11 Participants
n=11 Participants
|
23 Participants
n=25 Participants
|
|
Asthma medication at study entry
Low-dose inhaled corticosteroids (ICS) whenever SABA was taken
|
2 Participants
n=14 Participants
|
0 Participants
n=11 Participants
|
2 Participants
n=25 Participants
|
|
Number of exacerbations in the previous 12 months
|
0.14 Number of exacerbations
n=14 Participants
|
0.00 Number of exacerbations
n=11 Participants
|
0.08 Number of exacerbations
n=25 Participants
|
|
Number of participants with exacerbations (0 or 1) in the previous 12 months,
0 (no exacerbation)
|
12 Participants
n=14 Participants
|
11 Participants
n=11 Participants
|
23 Participants
n=25 Participants
|
|
Number of participants with exacerbations (0 or 1) in the previous 12 months,
1 (one exacerbation)
|
2 Participants
n=14 Participants
|
0 Participants
n=11 Participants
|
2 Participants
n=25 Participants
|
|
Time since the last exacerbation
|
194.03 months
n=5 Participants • This item presents data on the time since the last exacerbation (in months) and takes into account duration of longer than 12 months since the last exacerbation. Only participants with available date of the last exacerbation were considered.
|
212.40 months
n=1 Participants • This item presents data on the time since the last exacerbation (in months) and takes into account duration of longer than 12 months since the last exacerbation. Only participants with available date of the last exacerbation were considered.
|
197.09 months
n=6 Participants • This item presents data on the time since the last exacerbation (in months) and takes into account duration of longer than 12 months since the last exacerbation. Only participants with available date of the last exacerbation were considered.
|
|
Asthma Control Questionnaire 5 (ACQ-5) total score at screening
|
0.43 score
n=14 Participants
|
0.38 score
n=11 Participants
|
0.41 score
n=25 Participants
|
|
Asthma Control Questionnaire 5 (ACQ-5) total score on Day 1, pre-dose
|
0.33 score
n=14 Participants
|
0.29 score
n=11 Participants
|
0.31 score
n=25 Participants
|
PRIMARY outcome
Timeframe: At 15 min post-dose after T1.Population: Safety set was used: includes all subjects who were randomised and received at least one dose of study drug (HFA-152a or HFA-134a).
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).
Outcome measures
| Measure |
Test
n=25 Participants
Placebo HFA-152a propellant via pMDI:
Administration: Single-dose administration.
Placebo 152a: Placebo pMDI formulated with the 152a propellant
|
Reference
n=24 Participants
Placebo HFA-134a propellant via pMDI:
Administration: Single-dose administration.
Placebo 134a: Placebo pMDI formulated with the 134a propellant
|
|---|---|---|
|
Safety: Relative Change From Baseline* in Forced Expiratory Volume in 1 s (FEV1) -- 15 Min Post-dose
|
2.12 percent change
Interval 0.52 to 3.72
|
0.26 percent change
Interval -1.37 to 1.89
|
SECONDARY outcome
Timeframe: At 5 min, 30 min, 1 h, 1 h 30 min, and 3 h after T1.Population: Safety set was used: includes all subjects who were randomised and received at least one dose of study drug (HFA-152a or HFA-134a).
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).
Outcome measures
| Measure |
Test
n=25 Participants
Placebo HFA-152a propellant via pMDI:
Administration: Single-dose administration.
Placebo 152a: Placebo pMDI formulated with the 152a propellant
|
Reference
n=25 Participants
Placebo HFA-134a propellant via pMDI:
Administration: Single-dose administration.
Placebo 134a: Placebo pMDI formulated with the 134a propellant
|
|---|---|---|
|
Safety: Safety: Relative Change From Baseline* in FEV1 -- All Other Post-dose Time Points
5 min post-dose
|
0.25 percent change
Interval -0.85 to 1.35
|
-0.32 percent change
Interval -1.55 to 0.9
|
|
Safety: Safety: Relative Change From Baseline* in FEV1 -- All Other Post-dose Time Points
30 min post-dose
|
1.73 percent change
Interval 0.57 to 2.89
|
1.50 percent change
Interval 0.34 to 2.67
|
|
Safety: Safety: Relative Change From Baseline* in FEV1 -- All Other Post-dose Time Points
1 h post-dose
|
1.32 percent change
Interval 0.23 to 2.41
|
1.72 percent change
Interval 0.63 to 2.81
|
|
Safety: Safety: Relative Change From Baseline* in FEV1 -- All Other Post-dose Time Points
1.5 h post-dose
|
2.73 percent change
Interval 1.96 to 3.51
|
2.86 percent change
Interval 2.09 to 3.64
|
|
Safety: Safety: Relative Change From Baseline* in FEV1 -- All Other Post-dose Time Points
3 h post-dose
|
1.91 percent change
Interval 0.98 to 2.83
|
2.59 percent change
Interval 1.67 to 3.52
|
SECONDARY outcome
Timeframe: At 5 min, 15 min, 30 min, 1 h, 1 h 30 min, and 3 h after T1.Population: Safety set was used: includes all subjects who were randomised and received at least one dose of study drug (HFA-152a or HFA-134a).
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).
Outcome measures
| Measure |
Test
n=25 Participants
Placebo HFA-152a propellant via pMDI:
Administration: Single-dose administration.
Placebo 152a: Placebo pMDI formulated with the 152a propellant
|
Reference
n=25 Participants
Placebo HFA-134a propellant via pMDI:
Administration: Single-dose administration.
Placebo 134a: Placebo pMDI formulated with the 134a propellant
|
|---|---|---|
|
Safety: Absolute Change From Baseline* in FEV1 -- All Time Points Post Dose
5 min post-dose
|
0.008 Liter
Interval -0.022 to 0.038
|
-0.006 Liter
Interval -0.04 to 0.027
|
|
Safety: Absolute Change From Baseline* in FEV1 -- All Time Points Post Dose
15 min post-dose
|
0.066 Liter
Interval 0.018 to 0.114
|
0.005 Liter
Interval -0.043 to 0.054
|
|
Safety: Absolute Change From Baseline* in FEV1 -- All Time Points Post Dose
30 min post-dose
|
0.054 Liter
Interval 0.019 to 0.088
|
0.049 Liter
Interval 0.015 to 0.084
|
|
Safety: Absolute Change From Baseline* in FEV1 -- All Time Points Post Dose
1 h post-dose
|
0.045 Liter
Interval 0.012 to 0.078
|
0.056 Liter
Interval 0.023 to 0.089
|
|
Safety: Absolute Change From Baseline* in FEV1 -- All Time Points Post Dose
1.5 h post-dose
|
0.087 Liter
Interval 0.063 to 0.111
|
0.090 Liter
Interval 0.066 to 0.114
|
|
Safety: Absolute Change From Baseline* in FEV1 -- All Time Points Post Dose
3 h post-dose
|
0.059 Liter
Interval 0.028 to 0.09
|
0.082 Liter
Interval 0.051 to 0.113
|
SECONDARY outcome
Timeframe: At 5 min, 15 min, 30 min, 1 h, 1 h 30 min, and 3 h after T1.Population: Safety set was used: includes all subjects who were randomised and received at least one dose of study drug (HFA-152a or HFA-134a).
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).
Outcome measures
| Measure |
Test
n=25 Participants
Placebo HFA-152a propellant via pMDI:
Administration: Single-dose administration.
Placebo 152a: Placebo pMDI formulated with the 152a propellant
|
Reference
n=25 Participants
Placebo HFA-134a propellant via pMDI:
Administration: Single-dose administration.
Placebo 134a: Placebo pMDI formulated with the 134a propellant
|
|---|---|---|
|
Safety: Subjects With a Relative Change From Baseline* in FEV1 <-15% -- All Post-dose Time Points
5 min post-dose
|
0 Participants
|
0 Participants
|
|
Safety: Subjects With a Relative Change From Baseline* in FEV1 <-15% -- All Post-dose Time Points
15 min post-dose
|
0 Participants
|
0 Participants
|
|
Safety: Subjects With a Relative Change From Baseline* in FEV1 <-15% -- All Post-dose Time Points
30 min post-dose
|
0 Participants
|
0 Participants
|
|
Safety: Subjects With a Relative Change From Baseline* in FEV1 <-15% -- All Post-dose Time Points
1 h post-dose
|
0 Participants
|
0 Participants
|
|
Safety: Subjects With a Relative Change From Baseline* in FEV1 <-15% -- All Post-dose Time Points
1 h 30 min post-dose
|
0 Participants
|
0 Participants
|
|
Safety: Subjects With a Relative Change From Baseline* in FEV1 <-15% -- All Post-dose Time Points
3 h post-dose
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At 3 h post-dose.Population: Safety set was used: includes all subjects who were randomised and received at least one dose of study drug (HFA-152a or HFA-134a).
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).
Outcome measures
| Measure |
Test
n=25 Participants
Placebo HFA-152a propellant via pMDI:
Administration: Single-dose administration.
Placebo 152a: Placebo pMDI formulated with the 152a propellant
|
Reference
n=25 Participants
Placebo HFA-134a propellant via pMDI:
Administration: Single-dose administration.
Placebo 134a: Placebo pMDI formulated with the 134a propellant
|
|---|---|---|
|
Safety: Change From Baseline* in FEV1 Area Under the Concentration-time Curve From Time Zero to 3 Hours (AUC0-3h)
|
0.055 Litres
Standard Deviation 0.088
|
0.068 Litres
Standard Deviation 0.081
|
SECONDARY outcome
Timeframe: At 5 min, 15 min, 30 min, 1 h, 1 h 30 min, and 3 h after T1.Population: Safety set was used: includes all subjects who were randomised and received at least one dose of study drug (HFA-152a or HFA-134a).
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).
Outcome measures
| Measure |
Test
n=25 Participants
Placebo HFA-152a propellant via pMDI:
Administration: Single-dose administration.
Placebo 152a: Placebo pMDI formulated with the 152a propellant
|
Reference
n=25 Participants
Placebo HFA-134a propellant via pMDI:
Administration: Single-dose administration.
Placebo 134a: Placebo pMDI formulated with the 134a propellant
|
|---|---|---|
|
Safety: Relative Change From Baseline* in Peak Expiratory Flow (PEF) -- All Post-dose Time Points
5 min post-dose
|
-1.85 percent change
Standard Deviation 3.74
|
-2.35 percent change
Standard Deviation 3.69
|
|
Safety: Relative Change From Baseline* in Peak Expiratory Flow (PEF) -- All Post-dose Time Points
15 min post-dose
|
-0.62 percent change
Standard Deviation 4.31
|
-2.64 percent change
Standard Deviation 4.35
|
|
Safety: Relative Change From Baseline* in Peak Expiratory Flow (PEF) -- All Post-dose Time Points
30 min post-dose
|
-0.19 percent change
Standard Deviation 3.88
|
-0.28 percent change
Standard Deviation 3.20
|
|
Safety: Relative Change From Baseline* in Peak Expiratory Flow (PEF) -- All Post-dose Time Points
1 h post-dose
|
-0.12 percent change
Standard Deviation 3.95
|
0.11 percent change
Standard Deviation 4.82
|
|
Safety: Relative Change From Baseline* in Peak Expiratory Flow (PEF) -- All Post-dose Time Points
1 h 30 min post-dose
|
1.96 percent change
Standard Deviation 4.75
|
1.14 percent change
Standard Deviation 5.43
|
|
Safety: Relative Change From Baseline* in Peak Expiratory Flow (PEF) -- All Post-dose Time Points
3 h post-dose
|
1.08 percent change
Standard Deviation 3.57
|
1.62 percent change
Standard Deviation 4.77
|
SECONDARY outcome
Timeframe: At 5 min, 15 min, 30 min, 1 h, 1 h 30 min, and 3 h after T1.Population: Safety set was used: includes all subjects who were randomised and received at least one dose of study drug (HFA-152a or HFA-134a).
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).
Outcome measures
| Measure |
Test
n=25 Participants
Placebo HFA-152a propellant via pMDI:
Administration: Single-dose administration.
Placebo 152a: Placebo pMDI formulated with the 152a propellant
|
Reference
n=25 Participants
Placebo HFA-134a propellant via pMDI:
Administration: Single-dose administration.
Placebo 134a: Placebo pMDI formulated with the 134a propellant
|
|---|---|---|
|
Safety: Absolute Change From Baseline* in PEF -- All Post-dose Time Points
30 min post-dose
|
-0.8 Litres/min
Standard Deviation 20.2
|
-2.1 Litres/min
Standard Deviation 17.3
|
|
Safety: Absolute Change From Baseline* in PEF -- All Post-dose Time Points
5 min post-dose
|
-8.4 Litres/min
Standard Deviation 16.5
|
-12.5 Litres/min
Standard Deviation 20.8
|
|
Safety: Absolute Change From Baseline* in PEF -- All Post-dose Time Points
15 min post-dose
|
-2.0 Litres/min
Standard Deviation 20.2
|
-14.5 Litres/min
Standard Deviation 21.5
|
|
Safety: Absolute Change From Baseline* in PEF -- All Post-dose Time Points
1 h post-dose
|
0.0 Litres/min
Standard Deviation 20.0
|
-0.3 Litres/min
Standard Deviation 24.5
|
|
Safety: Absolute Change From Baseline* in PEF -- All Post-dose Time Points
1 h 30 min post-dose
|
9.9 Litres/min
Standard Deviation 23.4
|
3.9 Litres/min
Standard Deviation 29.5
|
|
Safety: Absolute Change From Baseline* in PEF -- All Post-dose Time Points
3 h post-dose
|
4.4 Litres/min
Standard Deviation 17.9
|
6.5 Litres/min
Standard Deviation 24.4
|
SECONDARY outcome
Timeframe: 3 h post-dose.Population: Safety set was used: includes all subjects who were randomised and received at least one dose of study drug (HFA-152a or HFA-134a).
Number and percentage of subjects with use of rescue medication in the 3 h post dose.
Outcome measures
| Measure |
Test
n=25 Participants
Placebo HFA-152a propellant via pMDI:
Administration: Single-dose administration.
Placebo 152a: Placebo pMDI formulated with the 152a propellant
|
Reference
n=25 Participants
Placebo HFA-134a propellant via pMDI:
Administration: Single-dose administration.
Placebo 134a: Placebo pMDI formulated with the 134a propellant
|
|---|---|---|
|
Safety: Subjects With Use of Rescue Medication -- 3 h Post Dose
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At 45 min, 1.75 h, 2.75 h post dose.Population: Safety set was used: includes all subjects who were randomised and received at least one dose of study drug (HFA-152a or HFA-134a).
Safety and tolerability: Mean change from baseline in the Vital Signs -- Diastolic Blood Pressure
Outcome measures
| Measure |
Test
n=25 Participants
Placebo HFA-152a propellant via pMDI:
Administration: Single-dose administration.
Placebo 152a: Placebo pMDI formulated with the 152a propellant
|
Reference
n=25 Participants
Placebo HFA-134a propellant via pMDI:
Administration: Single-dose administration.
Placebo 134a: Placebo pMDI formulated with the 134a propellant
|
|---|---|---|
|
Safety and Tolerability: Vital Signs -- Diastolic Blood Pressure
Baseline (actual value)
|
71.5 mmHg
Interval 57.0 to 89.0
|
72.5 mmHg
Interval 59.0 to 87.0
|
|
Safety and Tolerability: Vital Signs -- Diastolic Blood Pressure
45 min post dose (change from baseline)
|
1.4 mmHg
Interval -13.0 to 9.0
|
0.7 mmHg
Interval -14.0 to 12.0
|
|
Safety and Tolerability: Vital Signs -- Diastolic Blood Pressure
1.75 h post dose (change from baseline)
|
2.8 mmHg
Interval -8.0 to 8.0
|
1.2 mmHg
Interval -15.0 to 14.0
|
|
Safety and Tolerability: Vital Signs -- Diastolic Blood Pressure
2.75 h post dose (change from baseline)
|
-1.8 mmHg
Interval -12.0 to 9.0
|
-2.7 mmHg
Interval -18.0 to 13.0
|
SECONDARY outcome
Timeframe: At 45 min, 1.75 h, 2.75 h post dose.Population: Safety set was used: includes all subjects who were randomised and received at least one dose of study drug (HFA-152a or HFA-134a).
Safety and tolerability: Mean change from baseline in the Vital Signs -- Systolic Blood Pressure
Outcome measures
| Measure |
Test
n=25 Participants
Placebo HFA-152a propellant via pMDI:
Administration: Single-dose administration.
Placebo 152a: Placebo pMDI formulated with the 152a propellant
|
Reference
n=25 Participants
Placebo HFA-134a propellant via pMDI:
Administration: Single-dose administration.
Placebo 134a: Placebo pMDI formulated with the 134a propellant
|
|---|---|---|
|
Safety and Tolerability: Vital Signs -- Systolic Blood Pressure
Baseline (actual value)
|
117.4 mmHg
Interval 96.0 to 155.0
|
115.8 mmHg
Interval 100.0 to 135.0
|
|
Safety and Tolerability: Vital Signs -- Systolic Blood Pressure
45 min post dose (change from baseline)
|
2.3 mmHg
Interval -21.0 to 15.0
|
1.3 mmHg
Interval -16.0 to 21.0
|
|
Safety and Tolerability: Vital Signs -- Systolic Blood Pressure
1.75 h post dose (change from baseline)
|
4.9 mmHg
Interval -14.0 to 17.0
|
2.5 mmHg
Interval -9.0 to 21.0
|
|
Safety and Tolerability: Vital Signs -- Systolic Blood Pressure
2.75 h post dose (change from baseline)
|
1.0 mmHg
Interval -20.0 to 13.0
|
2.0 mmHg
Interval -9.0 to 12.0
|
SECONDARY outcome
Timeframe: At 45 min, 1.75 h, 2.75 h post dose.Population: Safety set was used: includes all subjects who were randomised and received at least one dose of study drug (HFA-152a or HFA-134a).
Safety and tolerability: Mean change from baseline in the ECG parameter -- Heart rate
Outcome measures
| Measure |
Test
n=25 Participants
Placebo HFA-152a propellant via pMDI:
Administration: Single-dose administration.
Placebo 152a: Placebo pMDI formulated with the 152a propellant
|
Reference
n=25 Participants
Placebo HFA-134a propellant via pMDI:
Administration: Single-dose administration.
Placebo 134a: Placebo pMDI formulated with the 134a propellant
|
|---|---|---|
|
Safety and Tolerability: ECG Parameter -- Heart Rate
Baseline (actual value)
|
59.4 beats/min
Interval 45.0 to 74.0
|
59.0 beats/min
Interval 43.0 to 83.0
|
|
Safety and Tolerability: ECG Parameter -- Heart Rate
45 min post dose (change from baseline)
|
-3.6 beats/min
Interval -19.0 to 7.0
|
-1.9 beats/min
Interval -12.0 to 11.0
|
|
Safety and Tolerability: ECG Parameter -- Heart Rate
1.75 h post dose (change from baseline)
|
-3.4 beats/min
Interval -15.0 to 7.0
|
-3.3 beats/min
Interval -13.0 to 6.0
|
|
Safety and Tolerability: ECG Parameter -- Heart Rate
2.75 h post dose (change from baseline)
|
5.0 beats/min
Interval -6.0 to 25.0
|
5.6 beats/min
Interval -6.0 to 13.0
|
SECONDARY outcome
Timeframe: At 45 min, 1.75 h, 2.75 h post dose.Population: Safety set was used: includes all subjects who were randomised and received at least one dose of study drug (HFA-152a or HFA-134a).
Safety and tolerability: Mean change from baseline in the ECG parameter -- PR interval.
Outcome measures
| Measure |
Test
n=25 Participants
Placebo HFA-152a propellant via pMDI:
Administration: Single-dose administration.
Placebo 152a: Placebo pMDI formulated with the 152a propellant
|
Reference
n=25 Participants
Placebo HFA-134a propellant via pMDI:
Administration: Single-dose administration.
Placebo 134a: Placebo pMDI formulated with the 134a propellant
|
|---|---|---|
|
Safety and Tolerability: ECG Parameter -- PR Interval
Baseline (actual value)
|
154.8 msec
Interval 104.0 to 203.0
|
154.2 msec
Interval 99.0 to 202.0
|
|
Safety and Tolerability: ECG Parameter -- PR Interval
45 min post dose (change from baseline)
|
-2.3 msec
Interval -47.0 to 8.0
|
0.4 msec
Interval -11.0 to 13.0
|
|
Safety and Tolerability: ECG Parameter -- PR Interval
1.75 h post dose (change from baseline)
|
-3.0 msec
Interval -43.0 to 15.0
|
-0.9 msec
Interval -28.0 to 14.0
|
|
Safety and Tolerability: ECG Parameter -- PR Interval
2.75 h post dose (change from baseline)
|
1.7 msec
Interval -7.0 to 22.0
|
-0.3 msec
Interval -10.0 to 12.0
|
SECONDARY outcome
Timeframe: At 45 min, 1.75 h, 2.75 h post dose.Population: Safety set was used: includes all subjects who were randomised and received at least one dose of study drug (HFA-152a or HFA-134a).
Safety and tolerability: Mean change from baseline in the ECG parameter -- QRS interval.
Outcome measures
| Measure |
Test
n=25 Participants
Placebo HFA-152a propellant via pMDI:
Administration: Single-dose administration.
Placebo 152a: Placebo pMDI formulated with the 152a propellant
|
Reference
n=25 Participants
Placebo HFA-134a propellant via pMDI:
Administration: Single-dose administration.
Placebo 134a: Placebo pMDI formulated with the 134a propellant
|
|---|---|---|
|
Safety and Tolerability: ECG Parameter -- QRS
Baseline (actual value)
|
96.6 msec
Interval 77.0 to 128.0
|
96.8 msec
Interval 78.0 to 128.0
|
|
Safety and Tolerability: ECG Parameter -- QRS
45 min post dose (change from baseline)
|
0.2 msec
Interval -9.0 to 9.0
|
0.7 msec
Interval -8.0 to 10.0
|
|
Safety and Tolerability: ECG Parameter -- QRS
1.75 h post dose (change from baseline)
|
1.6 msec
Interval -8.0 to 12.0
|
0.8 msec
Interval -5.0 to 12.0
|
|
Safety and Tolerability: ECG Parameter -- QRS
2.75 h post dose (change from baseline)
|
1.4 msec
Interval -11.0 to 10.0
|
0.8 msec
Interval -9.0 to 9.0
|
SECONDARY outcome
Timeframe: At 45 min, 1.75 h, 2.75 h post dose.Population: Safety set was used: includes all subjects who were randomised and received at least one dose of study drug (HFA-152a or HFA-134a).
Safety and tolerability: Mean change from baseline in the ECG parameter -- QTcF interval.
Outcome measures
| Measure |
Test
n=25 Participants
Placebo HFA-152a propellant via pMDI:
Administration: Single-dose administration.
Placebo 152a: Placebo pMDI formulated with the 152a propellant
|
Reference
n=25 Participants
Placebo HFA-134a propellant via pMDI:
Administration: Single-dose administration.
Placebo 134a: Placebo pMDI formulated with the 134a propellant
|
|---|---|---|
|
Safety and Tolerability: ECG Parameter -- QTcF Interval
Baseline (actual value)
|
408.4 msec
Interval 380.0 to 442.0
|
409.0 msec
Interval 382.0 to 449.0
|
|
Safety and Tolerability: ECG Parameter -- QTcF Interval
45 min post dose (change from baseline)
|
0.8 msec
Interval -14.0 to 16.0
|
0.1 msec
Interval -14.0 to 18.0
|
|
Safety and Tolerability: ECG Parameter -- QTcF Interval
1.75 h post dose (change from baseline)
|
4.6 msec
Interval -12.0 to 23.0
|
-0.1 msec
Interval -25.0 to 18.0
|
|
Safety and Tolerability: ECG Parameter -- QTcF Interval
2.75 h post dose (change from baseline)
|
5.7 msec
Interval -11.0 to 35.0
|
1.5 msec
Interval -15.0 to 19.0
|
Adverse Events
Test
Reference
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Test
n=25 participants at risk
Placebo HFA-152a propellant via pMDI:
Administration: Single-dose administration.
Placebo 152a: Placebo pMDI formulated with the 152a propellant
|
Reference
n=25 participants at risk
Placebo HFA-134a propellant via pMDI:
Administration: Single-dose administration.
Placebo 134a: Placebo pMDI formulated with the 134a propellant
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/25 • Adverse events (AEs) were monitored from the screening visit (between 2-21 days before TP1 of the study) to the termination visit, up to 6 weeks.
Safety set was used for the evaluation of AEs. Safety set included all subjects who were randomised and received at least one dose of study drug (HFA-152a or HFA-134a).
|
4.0%
1/25 • Number of events 1 • Adverse events (AEs) were monitored from the screening visit (between 2-21 days before TP1 of the study) to the termination visit, up to 6 weeks.
Safety set was used for the evaluation of AEs. Safety set included all subjects who were randomised and received at least one dose of study drug (HFA-152a or HFA-134a).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
4.0%
1/25 • Number of events 1 • Adverse events (AEs) were monitored from the screening visit (between 2-21 days before TP1 of the study) to the termination visit, up to 6 weeks.
Safety set was used for the evaluation of AEs. Safety set included all subjects who were randomised and received at least one dose of study drug (HFA-152a or HFA-134a).
|
0.00%
0/25 • Adverse events (AEs) were monitored from the screening visit (between 2-21 days before TP1 of the study) to the termination visit, up to 6 weeks.
Safety set was used for the evaluation of AEs. Safety set included all subjects who were randomised and received at least one dose of study drug (HFA-152a or HFA-134a).
|
|
Infections and infestations
Rhinitis
|
0.00%
0/25 • Adverse events (AEs) were monitored from the screening visit (between 2-21 days before TP1 of the study) to the termination visit, up to 6 weeks.
Safety set was used for the evaluation of AEs. Safety set included all subjects who were randomised and received at least one dose of study drug (HFA-152a or HFA-134a).
|
8.0%
2/25 • Number of events 2 • Adverse events (AEs) were monitored from the screening visit (between 2-21 days before TP1 of the study) to the termination visit, up to 6 weeks.
Safety set was used for the evaluation of AEs. Safety set included all subjects who were randomised and received at least one dose of study drug (HFA-152a or HFA-134a).
|
|
General disorders
Chest discomfort
|
0.00%
0/25 • Adverse events (AEs) were monitored from the screening visit (between 2-21 days before TP1 of the study) to the termination visit, up to 6 weeks.
Safety set was used for the evaluation of AEs. Safety set included all subjects who were randomised and received at least one dose of study drug (HFA-152a or HFA-134a).
|
4.0%
1/25 • Number of events 1 • Adverse events (AEs) were monitored from the screening visit (between 2-21 days before TP1 of the study) to the termination visit, up to 6 weeks.
Safety set was used for the evaluation of AEs. Safety set included all subjects who were randomised and received at least one dose of study drug (HFA-152a or HFA-134a).
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/25 • Adverse events (AEs) were monitored from the screening visit (between 2-21 days before TP1 of the study) to the termination visit, up to 6 weeks.
Safety set was used for the evaluation of AEs. Safety set included all subjects who were randomised and received at least one dose of study drug (HFA-152a or HFA-134a).
|
4.0%
1/25 • Number of events 1 • Adverse events (AEs) were monitored from the screening visit (between 2-21 days before TP1 of the study) to the termination visit, up to 6 weeks.
Safety set was used for the evaluation of AEs. Safety set included all subjects who were randomised and received at least one dose of study drug (HFA-152a or HFA-134a).
|
Additional Information
Clinical Trial Transparency
Chiesi Farmaceutici S.p.A.
Results disclosure agreements
- Principal investigator is a sponsor employee Investigators should inform Chiesi Farmaceutici S.p.A. before using the results of the study for publication or presentation, and agree to provide the Sponsor with a copy of the proposed presentation.
- Publication restrictions are in place
Restriction type: OTHER