Study of the Effect of HFA-152a and HFA-134a Propellants on Mucociliary Clearance in Healthy Participants

Sponsor
GlaxoSmithKline
Study ID
NCT06506266
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
30 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • HFA-152a — OTHER
    HFA-152a is administered via oral inhalation
  • HFA-134a — OTHER
    HFA-134a is administered via oral inhalation
  • Radiolabeled saline solution — OTHER
    Radiolabeled saline solution is administered via oral inhalation

Study Details

The main goal of the study is to assess the effect of the administration of reference propellant \[HFA-134a (1,1,1,2 - Tetrafluoroethane)\] and test propellant \[HFA-152a (1 - Difluoroethane)\] in healthy adults on mucociliary clearance (MCC).

Key Dates

Start date
Jul 29, 2024
Status verified
Mar 2026
Primary completion
Oct 24, 2024
Completion
Oct 24, 2024

Study Design

Enrollment
24 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: HFA-152a followed by HFA-134a
  • Experimental: HFA-134a followed by HFA-152a

Primary Outcome Measure

Area Under the Percent Radiolabeled Particle Retention-time Curve up to 4 Hours [AUC(0-4h)] After Nebulized 99mTechnetium (99mTc) Inhalation on Day 7 [ Time Frame: At 0, 15, 30, 45, 60, 90, 120, 150, 180, 210, and 240 minutes on Day 7 ]

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