Trial Outcomes & Findings for A Study to Assess the Potential for Airway Sensitivity Reactions With Propellants HFA-152a (Test) and HFA-134a (Reference) Administered Via Pressurized Inhalers in Adults With Mild Asthma (NCT NCT06702462)
NCT ID: NCT06702462
Last Updated: 2026-08-21
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
20 participants
Primary outcome timeframe
Baseline (Day 1, pre-dose) and at 15 minutes post-dose
Results posted on
2026-08-21
Participant Flow
Participant milestones
| Measure |
Salbutamol HFA-152a (Test) Followed by Salbutamol HFA-134a (Reference)
Participants with mild asthma received Salbutamol Hydrofluoroalkane (HFA)-152a (Test) inhalation via pressurized metered dose inhalers (pMDIs) as a single 504 microliters (µl) (8 x 63 µl dose at 20-second intervals) on Day 1 of treatment period 1. In treatment period 2, participants received Salbutamol HFA-134a (Reference) as a single 504 µl (8 x 63 µl dose at 20-second intervals) inhalation on Day 2.
|
Salbutamol HFA-134a (Reference) Followed by Salbutamol HFA-152a (Test)
Participants with mild asthma received Salbutamol Hydrofluoroalkane (HFA)-134a (Reference) inhalation via pressurized metered dose inhalers (pMDIs) as a single 504 microliters (µl) (8 x 63 µl dose at 20-second intervals) on Day 1 of treatment period 1. In treatment period 2, participants received Salbutamol HFA-152a (Test) as a single 504 µl (8 x 63 µl dose at 20-second intervals) inhalation on Day 2.
|
|---|---|---|
|
Period 1
STARTED
|
9
|
11
|
|
Period 1
COMPLETED
|
8
|
11
|
|
Period 1
NOT COMPLETED
|
1
|
0
|
|
Period 2
STARTED
|
8
|
11
|
|
Period 2
COMPLETED
|
8
|
11
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Salbutamol HFA-152a (Test) Followed by Salbutamol HFA-134a (Reference)
Participants with mild asthma received Salbutamol Hydrofluoroalkane (HFA)-152a (Test) inhalation via pressurized metered dose inhalers (pMDIs) as a single 504 microliters (µl) (8 x 63 µl dose at 20-second intervals) on Day 1 of treatment period 1. In treatment period 2, participants received Salbutamol HFA-134a (Reference) as a single 504 µl (8 x 63 µl dose at 20-second intervals) inhalation on Day 2.
|
Salbutamol HFA-134a (Reference) Followed by Salbutamol HFA-152a (Test)
Participants with mild asthma received Salbutamol Hydrofluoroalkane (HFA)-134a (Reference) inhalation via pressurized metered dose inhalers (pMDIs) as a single 504 microliters (µl) (8 x 63 µl dose at 20-second intervals) on Day 1 of treatment period 1. In treatment period 2, participants received Salbutamol HFA-152a (Test) as a single 504 µl (8 x 63 µl dose at 20-second intervals) inhalation on Day 2.
|
|---|---|---|
|
Period 1
Adverse Event
|
1
|
0
|
Baseline Characteristics
A Study to Assess the Potential for Airway Sensitivity Reactions With Propellants HFA-152a (Test) and HFA-134a (Reference) Administered Via Pressurized Inhalers in Adults With Mild Asthma
Baseline characteristics by cohort
| Measure |
Salbutamol HFA-152a (Test) Followed by Salbutamol HFA-134a (Reference)
n=9 Participants
Participants with mild asthma received Salbutamol Hydrofluoroalkane (HFA)-152a (Test) inhalation via pressurized metered dose inhalers (pMDIs) as a single 504 microliters (µl) (8 x 63 µl dose at 20-second intervals) on Day 1 of treatment period 1. In treatment period 2, participants received Salbutamol HFA-134a (Reference) as a single 504 µl (8 x 63 µl dose at 20-second intervals) inhalation on Day 2.
|
Salbutamol HFA-134a (Reference) Followed by Salbutamol HFA-152a (Test)
n=11 Participants
Participants with mild asthma received Salbutamol Hydrofluoroalkane (HFA)-134a (Reference) inhalation via pressurized metered dose inhalers (pMDIs) as a single 504 microliters (µl) (8 x 63 µl dose at 20-second intervals) on Day 1 of treatment period 1. In treatment period 2, participants received Salbutamol HFA-152a (Test) as a single 504 µl (8 x 63 µl dose at 20-second intervals) inhalation on Day 2.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
36.0 years
STANDARD_DEVIATION 8.66 • n=5 Participants
|
30.0 years
STANDARD_DEVIATION 6.50 • n=109 Participants
|
32.7 years
STANDARD_DEVIATION 7.95 • n=133 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
6 Participants
n=109 Participants
|
10 Participants
n=133 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
5 Participants
n=109 Participants
|
10 Participants
n=133 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=109 Participants
|
0 Participants
n=133 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=109 Participants
|
2 Participants
n=133 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=109 Participants
|
0 Participants
n=133 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
4 Participants
n=109 Participants
|
9 Participants
n=133 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
6 Participants
n=109 Participants
|
8 Participants
n=133 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=109 Participants
|
0 Participants
n=133 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=109 Participants
|
1 Participants
n=133 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1, pre-dose) and at 15 minutes post-dosePopulation: Fully complaint analysis set (FCAS) population included all participants who were able to adhere to the dose of study intervention as prescribed and completed the study.
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.
Outcome measures
| Measure |
Salbutamol HFA-152a (Test)
n=19 Participants
Participants with mild asthma received Salbutamol HFA-152a (Test) as a single dose of 8 inhalations at 20 second intervals with 63 ul delivered in each inhalation.
|
Salbutamol HFA-134a (Reference)
n=19 Participants
Participants with mild asthma received Salbutamol HFA-134a (Reference) as a single dose of 8 inhalations at 20 second intervals with 63 ul delivered in each inhalation.
|
|---|---|---|
|
Percentage Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at 15 Minutes Post-dose
|
-0.37 Percentage change
Interval -3.42 to 2.68
|
-0.60 Percentage change
Interval -3.65 to 2.44
|
SECONDARY outcome
Timeframe: Up to 15 minutes post-dosePopulation: FCAS population
FEV1 was measured using spirometry. AUC was assessed from the first non-missing timepoint to the 15 minute time point.
Outcome measures
| Measure |
Salbutamol HFA-152a (Test)
n=19 Participants
Participants with mild asthma received Salbutamol HFA-152a (Test) as a single dose of 8 inhalations at 20 second intervals with 63 ul delivered in each inhalation.
|
Salbutamol HFA-134a (Reference)
n=19 Participants
Participants with mild asthma received Salbutamol HFA-134a (Reference) as a single dose of 8 inhalations at 20 second intervals with 63 ul delivered in each inhalation.
|
|---|---|---|
|
Area Under the Curve for FEV1 From Time Zero to 15 Minutes (FEV1 AUC0-15 Mins)
|
48.51 Liter*minutes (L*mins)
Interval 43.83 to 53.18
|
49.56 Liter*minutes (L*mins)
Interval 44.88 to 54.24
|
SECONDARY outcome
Timeframe: Baseline (Day 1, pre-dose) and at 5, 60, and 180 minutes post-dosePopulation: FCAS population
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.
Outcome measures
| Measure |
Salbutamol HFA-152a (Test)
n=19 Participants
Participants with mild asthma received Salbutamol HFA-152a (Test) as a single dose of 8 inhalations at 20 second intervals with 63 ul delivered in each inhalation.
|
Salbutamol HFA-134a (Reference)
n=19 Participants
Participants with mild asthma received Salbutamol HFA-134a (Reference) as a single dose of 8 inhalations at 20 second intervals with 63 ul delivered in each inhalation.
|
|---|---|---|
|
Percentage Change From Baseline in FEV1 at 5, 60, and 180 Minutes Post-dose
Change from baseline (CFB) to 5 mins post-dose
|
1.89 Percentage change
Interval -1.15 to 4.94
|
3.64 Percentage change
Interval 0.59 to 6.69
|
|
Percentage Change From Baseline in FEV1 at 5, 60, and 180 Minutes Post-dose
CFB to 60 mins post-dose
|
0.56 Percentage change
Interval -2.49 to 3.61
|
-0.30 Percentage change
Interval -3.35 to 2.75
|
|
Percentage Change From Baseline in FEV1 at 5, 60, and 180 Minutes Post-dose
CFB to 180 mins post-dose
|
2.82 Percentage change
Interval -0.23 to 5.86
|
0.24 Percentage change
Interval -2.81 to 3.29
|
SECONDARY outcome
Timeframe: Baseline (Day 1, pre-dose) and at 5, 15, 60 and 180 minutes post-dosePopulation: FCAS population
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.
Outcome measures
| Measure |
Salbutamol HFA-152a (Test)
n=19 Participants
Participants with mild asthma received Salbutamol HFA-152a (Test) as a single dose of 8 inhalations at 20 second intervals with 63 ul delivered in each inhalation.
|
Salbutamol HFA-134a (Reference)
n=19 Participants
Participants with mild asthma received Salbutamol HFA-134a (Reference) as a single dose of 8 inhalations at 20 second intervals with 63 ul delivered in each inhalation.
|
|---|---|---|
|
Number of Participants With Percentage Change From Baseline in FEV1 <-15% at Timepoints 5, 15, 60 and 180 Minutes Post-dose
5 mins post-dose
|
0 Participants
|
0 Participants
|
|
Number of Participants With Percentage Change From Baseline in FEV1 <-15% at Timepoints 5, 15, 60 and 180 Minutes Post-dose
15 mins post-dose
|
0 Participants
|
1 Participants
|
|
Number of Participants With Percentage Change From Baseline in FEV1 <-15% at Timepoints 5, 15, 60 and 180 Minutes Post-dose
60 mins post-dose
|
0 Participants
|
1 Participants
|
|
Number of Participants With Percentage Change From Baseline in FEV1 <-15% at Timepoints 5, 15, 60 and 180 Minutes Post-dose
180 mins post-dose
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to approximately 85 daysPopulation: Safety population included participants who received at least one dose of study intervention.
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.
Outcome measures
| Measure |
Salbutamol HFA-152a (Test)
n=20 Participants
Participants with mild asthma received Salbutamol HFA-152a (Test) as a single dose of 8 inhalations at 20 second intervals with 63 ul delivered in each inhalation.
|
Salbutamol HFA-134a (Reference)
n=19 Participants
Participants with mild asthma received Salbutamol HFA-134a (Reference) as a single dose of 8 inhalations at 20 second intervals with 63 ul delivered in each inhalation.
|
|---|---|---|
|
Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs)
AE
|
1 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs)
SAE
|
0 Participants
|
0 Participants
|
Adverse Events
Salbutamol HFA-152a (Test)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Salbutamol HFA-134a (Reference)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Salbutamol HFA-152a (Test)
n=20 participants at risk
Participants with mild asthma received Salbutamol HFA-152a (Test) as a single dose of 8 inhalations at 20 second intervals with 63 ul delivered in each inhalation.
|
Salbutamol HFA-134a (Reference)
n=19 participants at risk
Participants with mild asthma received Salbutamol HFA-134a (Reference) as a single dose of 8 inhalations at 20 second intervals with 63 ul delivered in each inhalation.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
5.0%
1/20 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were collected up to approximately 85 days.
Safety population included participants who received at least one dose of study intervention.
|
0.00%
0/19 • All-cause mortality, non-SAEs and SAEs were collected up to approximately 85 days.
Safety population included participants who received at least one dose of study intervention.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/20 • All-cause mortality, non-SAEs and SAEs were collected up to approximately 85 days.
Safety population included participants who received at least one dose of study intervention.
|
5.3%
1/19 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were collected up to approximately 85 days.
Safety population included participants who received at least one dose of study intervention.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
5.0%
1/20 • Number of events 1 • All-cause mortality, non-SAEs and SAEs were collected up to approximately 85 days.
Safety population included participants who received at least one dose of study intervention.
|
0.00%
0/19 • All-cause mortality, non-SAEs and SAEs were collected up to approximately 85 days.
Safety population included participants who received at least one dose of study intervention.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER