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
Study complete
Study complete
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
    Primary completion date:
    2025-04-06
    Observational study model:
    Not applicable
    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
    Study complete
    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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