Last updated: 08/19/2025 07:20:36

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

GSK study ID
223166
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A randomized, non-inferiority, double-blind, controlled, single-dose, 2-way cross-over study to assess the potential for airway sensitivity reactions with propellants HFA-152a (Test) and HFA-134a (Reference) administered via pressurized metered dose inhalers in adults aged 18-45 with mild asthma
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Cross-over
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:

Percentage change from baseline in Forced expiratory volume in 1 second (FEV1) at 15 minutes

Timeframe: Baseline (0 minutes) and at 15 minutes post dose

Secondary outcomes:

Area under the forced expiratory volume in 1 second-time curve from zero to 15 minutes (FEV1 AUC0-15min)

Timeframe: Up to 15 minutes post dose

Percentage change from baseline in FEV1 at 5, 60 and 180 minutes

Timeframe: Baseline (0 minutes) and at 5, 60 and 180 minutes post dose

Percentage change from baseline in FEV1 <-15% at timepoints 5, 15, 60 and 180 minutes

Timeframe: Baseline (0 minutes) and at 5, 15, 60 and 180 minutes post dose

Number of participants with adverse events (AEs) and serious adverse events (SAEs)

Timeframe: Up to approximately 54 days

Interventions:
Drug: HFA-152A propellant
Drug: HFA-134A propellant
Enrollment:
20
Observational study model:
Not applicable
Primary completion date:
2025-04-06
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Asthma
Product
salbutamol
Collaborators
Not applicable
Study date(s)
March 2025 to June 2025
Type
Interventional
Phase
1

Participation criteria

Sex
Female & Male
Age
18 - 45 Years
Accepts healthy volunteers
No
  • Participants are eligible to be included in the study if all the following criteria apply:
  • Male or female; females may be of childbearing potential, of nonchildbearing potential, or postmenopausal.
  • Participants are excluded from the study if any of the following criteria apply:
  • A history of life-threatening asthma or asthma that is unstable in the opinion of the investigator.

Trial location(s)

Location
Status
Contact us
Contact us
Location
GSK Investigational Site
San Antonio, TX, United States, 78209
Status
Study Complete
Location
GSK Investigational Site
Marlton, NJ, United States, 08053
Status
Study Complete
Location
GSK Investigational Site
Anniston, AL, United States, 36207
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Huntersville, NC, United States, 28078
Status
Study Complete

Study documents

No study documents available.

Results overview

Study Results yet to be posted

Recruitment status
Completed
Actual primary completion date
2025-04-06
Actual study completion date
2025-04-06

Plain language summaries

Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

Additional information about the trial

Additional information
Not applicable
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