Trial Outcomes & Findings for Study of the Effect of HFA-152a and HFA-134a Propellants on Mucociliary Clearance in Healthy Participants (NCT NCT06506266)
NCT ID: NCT06506266
Last Updated: 2026-04-14
Results Overview
\[AUC(0-4h)\] was assessed for Mucociliary clearance (MCC) in participants following administration of nebulized 99mTc on Day 7. Gamma scintigraphy was utilized to conduct assessments.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
24 participants
Primary outcome timeframe
At 0, 15, 30, 45, 60, 90, 120, 150, 180, 210, and 240 minutes on Day 7
Results posted on
2026-04-14
Participant Flow
Participant milestones
| Measure |
HFA-152a Followed by HFA-134a
Healthy participants received 1-Difluoroethane (Test propellant) HFA-152a as 4 oral inhalations taken twice daily for up to six days and a single dose on the morning of the seventh day during treatment period 1. In treatment period 2, participants received 1,1,1,2-Tetrafluoroethane (Reference propellant) HFA-134a as 4 oral inhalations taken twice daily for up to six days and a single dose on the morning of the seventh day.
|
HFA-134a Followed by HFA-152a
Healthy participants received 1,1,1,2-Tetrafluoroethane (Reference propellant) HFA-134a as 4 oral inhalations taken twice daily for up to six days and a single dose on the morning of the seventh day during treatment period 1. In treatment period 2, participants received 1-Difluoroethane (Test propellant) HFA-152a as 4 oral inhalations taken twice daily for up to six days and a single dose on the morning of the seventh day.
|
|---|---|---|
|
Treatment Period 1
STARTED
|
12
|
12
|
|
Treatment Period 1
Mucociliary Clearance Analysis Population
|
10
|
12
|
|
Treatment Period 1
COMPLETED
|
10
|
12
|
|
Treatment Period 1
NOT COMPLETED
|
2
|
0
|
|
Treatment Period 2
STARTED
|
10
|
12
|
|
Treatment Period 2
Mucociliary Clearance Analysis Population
|
10
|
12
|
|
Treatment Period 2
COMPLETED
|
10
|
12
|
|
Treatment Period 2
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
HFA-152a Followed by HFA-134a
Healthy participants received 1-Difluoroethane (Test propellant) HFA-152a as 4 oral inhalations taken twice daily for up to six days and a single dose on the morning of the seventh day during treatment period 1. In treatment period 2, participants received 1,1,1,2-Tetrafluoroethane (Reference propellant) HFA-134a as 4 oral inhalations taken twice daily for up to six days and a single dose on the morning of the seventh day.
|
HFA-134a Followed by HFA-152a
Healthy participants received 1,1,1,2-Tetrafluoroethane (Reference propellant) HFA-134a as 4 oral inhalations taken twice daily for up to six days and a single dose on the morning of the seventh day during treatment period 1. In treatment period 2, participants received 1-Difluoroethane (Test propellant) HFA-152a as 4 oral inhalations taken twice daily for up to six days and a single dose on the morning of the seventh day.
|
|---|---|---|
|
Treatment Period 1
Non-compliance with study drug
|
1
|
0
|
|
Treatment Period 1
Met protocol specific withdrawal criteria
|
1
|
0
|
Baseline Characteristics
Study of the Effect of HFA-152a and HFA-134a Propellants on Mucociliary Clearance in Healthy Participants
Baseline characteristics by cohort
| Measure |
HFA-152a Followed by HFA-134a
n=12 Participants
Healthy participants received 1-Difluoroethane (Test propellant) HFA-152a as 4 oral inhalations taken twice daily for up to six days and a single dose on the morning of the seventh day during treatment period 1. In treatment period 2, participants received 1,1,1,2-Tetrafluoroethane (Reference propellant) HFA-134a as 4 oral inhalations taken twice daily for up to six days and a single dose on the morning of the seventh day.
|
HFA-134a Followed by HFA-152a
n=12 Participants
Healthy participants received 1,1,1,2-Tetrafluoroethane (Reference propellant) HFA-134a as 4 oral inhalations taken twice daily for up to six days and a single dose on the morning of the seventh day during treatment period 1. In treatment period 2, participants received 1-Difluoroethane (Test propellant) HFA-152a as 4 oral inhalations taken twice daily for up to six days and a single dose on the morning of the seventh day.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
42.3 YEARS
STANDARD_DEVIATION 7.09 • n=193 Participants
|
41.9 YEARS
STANDARD_DEVIATION 4.52 • n=193 Participants
|
42.1 YEARS
STANDARD_DEVIATION 5.82 • n=386 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=193 Participants
|
12 Participants
n=193 Participants
|
24 Participants
n=386 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=193 Participants
|
1 Participants
n=193 Participants
|
2 Participants
n=386 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=193 Participants
|
1 Participants
n=193 Participants
|
3 Participants
n=386 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=193 Participants
|
10 Participants
n=193 Participants
|
19 Participants
n=386 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
PRIMARY outcome
Timeframe: At 0, 15, 30, 45, 60, 90, 120, 150, 180, 210, and 240 minutes on Day 7Population: Mucociliary Clearance (MCC) analysis population included all participants who were able to adhere to all doses of study intervention as prescribed and completed the study.
\[AUC(0-4h)\] was assessed for Mucociliary clearance (MCC) in participants following administration of nebulized 99mTc on Day 7. Gamma scintigraphy was utilized to conduct assessments.
Outcome measures
| Measure |
HFA-152a
n=22 Participants
Healthy participants received 1-Difluoroethane (Test propellant) HFA-152a as 4 oral inhalations taken twice daily for up to six days and a single dose on the morning of the seventh day (in either treatment periods 1 or 2)
|
HFA-134a
n=22 Participants
Healthy participants received 1,1,1,2-Tetrafluoroethane (Reference propellant) HFA-134a as 4 oral inhalations taken twice daily for up to six days and a single dose on the morning of the seventh day (in either treatment periods 1 or 2)
|
|---|---|---|
|
Area Under the Percent Radiolabeled Particle Retention-time Curve up to 4 Hours [AUC(0-4h)] After Nebulized 99mTechnetium (99mTc) Inhalation on Day 7
|
351.57 Hour*percentage (%)
Interval 338.06 to 365.61
|
351.76 Hour*percentage (%)
Interval 338.25 to 365.81
|
SECONDARY outcome
Timeframe: 1 hour after inhalation on Day 7Population: Mucociliary Clearance (MCC) analysis population included all participants who were able to adhere to all doses of study intervention as prescribed and completed the study.
Gamma scintigraphy was utilized to conduct assessments.
Outcome measures
| Measure |
HFA-152a
n=22 Participants
Healthy participants received 1-Difluoroethane (Test propellant) HFA-152a as 4 oral inhalations taken twice daily for up to six days and a single dose on the morning of the seventh day (in either treatment periods 1 or 2)
|
HFA-134a
n=22 Participants
Healthy participants received 1,1,1,2-Tetrafluoroethane (Reference propellant) HFA-134a as 4 oral inhalations taken twice daily for up to six days and a single dose on the morning of the seventh day (in either treatment periods 1 or 2)
|
|---|---|---|
|
Percentage of Radiolabeled Particle Retention at 1 Hour After Nebulized 99mTechnetium (99mTc) Inhalation on Day 7
|
91.25 % of radiolabeled particle retention
Interval 87.34 to 95.16
|
91.20 % of radiolabeled particle retention
Interval 87.29 to 95.11
|
SECONDARY outcome
Timeframe: 1.5 hours after inhalation on Day 7Population: Mucociliary Clearance (MCC) analysis population included all participants who were able to adhere to all doses of study intervention as prescribed and completed the study.
Gamma scintigraphy was utilized to conduct assessments.
Outcome measures
| Measure |
HFA-152a
n=22 Participants
Healthy participants received 1-Difluoroethane (Test propellant) HFA-152a as 4 oral inhalations taken twice daily for up to six days and a single dose on the morning of the seventh day (in either treatment periods 1 or 2)
|
HFA-134a
n=22 Participants
Healthy participants received 1,1,1,2-Tetrafluoroethane (Reference propellant) HFA-134a as 4 oral inhalations taken twice daily for up to six days and a single dose on the morning of the seventh day (in either treatment periods 1 or 2)
|
|---|---|---|
|
Percentage of Radiolabeled Particle Retention at 1.5 Hours After Nebulized 99mTechnetium (99mTc) Inhalation on Day 7
|
89.34 % of radiolabeled particle retention
Interval 84.88 to 93.8
|
89.30 % of radiolabeled particle retention
Interval 84.84 to 93.77
|
SECONDARY outcome
Timeframe: 3 hours after inhalation on Day 7Population: Mucociliary Clearance (MCC) analysis population included all participants who were able to adhere to all doses of study intervention as prescribed and completed the study.
Gamma scintigraphy was utilized to conduct assessments.
Outcome measures
| Measure |
HFA-152a
n=22 Participants
Healthy participants received 1-Difluoroethane (Test propellant) HFA-152a as 4 oral inhalations taken twice daily for up to six days and a single dose on the morning of the seventh day (in either treatment periods 1 or 2)
|
HFA-134a
n=22 Participants
Healthy participants received 1,1,1,2-Tetrafluoroethane (Reference propellant) HFA-134a as 4 oral inhalations taken twice daily for up to six days and a single dose on the morning of the seventh day (in either treatment periods 1 or 2)
|
|---|---|---|
|
Percentage of Radiolabeled Particle Retention at 3 Hours After Nebulized 99mTechnetium (99mTc) Inhalation on Day 7
|
84.84 % of radiolabeled particle retention
Interval 80.94 to 88.74
|
85.02 % of radiolabeled particle retention
Interval 81.12 to 88.92
|
SECONDARY outcome
Timeframe: Up to approximately 13 weeksPopulation: Safety population included all participants who received at least one dose of study intervention.
An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose, results in death; was life threatening; required hospitalization or prolongation of existing hospitalization; resulted in disability/incapacity; was a congenital anomaly/birth defect, abnormal pregnancy outcomes. SAEs are subset of AEs. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) coding system. The AE data presented below is of frequency threshold - 0%.
Outcome measures
| Measure |
HFA-152a
n=24 Participants
Healthy participants received 1-Difluoroethane (Test propellant) HFA-152a as 4 oral inhalations taken twice daily for up to six days and a single dose on the morning of the seventh day (in either treatment periods 1 or 2)
|
HFA-134a
n=22 Participants
Healthy participants received 1,1,1,2-Tetrafluoroethane (Reference propellant) HFA-134a as 4 oral inhalations taken twice daily for up to six days and a single dose on the morning of the seventh day (in either treatment periods 1 or 2)
|
|---|---|---|
|
Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs)
Any AE
|
9 Participants
|
7 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs)
Any SAE
|
0 Participants
|
0 Participants
|
Adverse Events
HFA-152a
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
HFA-134a
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
HFA-152a
n=24 participants at risk
Healthy participants received 1-Difluoroethane (Test propellant) HFA-152a as 4 oral inhalations taken twice daily for up to six days and a single dose on the morning of the seventh day (in either treatment periods 1 or 2)
|
HFA-134a
n=22 participants at risk
Healthy participants received 1,1,1,2-Tetrafluoroethane (Reference propellant) HFA-134a as 4 oral inhalations taken twice daily for up to six days and a single dose on the morning of the seventh day (in either treatment periods 1 or 2)
|
|---|---|---|
|
Nervous system disorders
Headache
|
8.3%
2/24 • Number of events 2 • All-cause mortality, non-serious adverse events (Non-SAEs) and SAEs were collected up to approximately 13 weeks.
Safety population included all participants who received at least one dose of study intervention.
|
13.6%
3/22 • Number of events 3 • All-cause mortality, non-serious adverse events (Non-SAEs) and SAEs were collected up to approximately 13 weeks.
Safety population included all participants who received at least one dose of study intervention.
|
|
General disorders
Medical device site rash
|
0.00%
0/24 • All-cause mortality, non-serious adverse events (Non-SAEs) and SAEs were collected up to approximately 13 weeks.
Safety population included all participants who received at least one dose of study intervention.
|
9.1%
2/22 • Number of events 2 • All-cause mortality, non-serious adverse events (Non-SAEs) and SAEs were collected up to approximately 13 weeks.
Safety population included all 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