A Study to Compare Safety of 4 Weeks Exposure to Propellants Hydrofluoroalkane 1,1-difluoroethane (HFA-152a) and HFA-1,1,1,2-tetrafluoroethane (134a)

Sponsor
GlaxoSmithKline
Study ID
NCT07645248
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • HFA-152a — DRUG
    HFA-152a will be administered.
  • HFA-134a — DRUG
    HFA-134a will be administered.

Study Details

This study aims to generate additional safety data on the propellant component of the reformulated product by comparing metered dose inhaler (MDIs) containing HFA-152a (test) with HFA-134a (reference).

Key Dates

First listed
Jun 12, 2026
Start date
Sep 15, 2026
Status verified
Jun 2026
Primary completion
Feb 25, 2027
Completion
Feb 25, 2027

Study Design

Enrollment
110 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Participants receiving HFA-152a followed by HFA-134a
    Participants will receive HFA-152a MDI in treatment period 1 followed by HFA-134a MDI in treatment period 2. There will be a washout period between the treatment periods.
  • Experimental: Participants receiving HFA-134a followed by HFA-152a
    Participants will receive HFA-134a MDI in treatment period 1 followed by HFA-152a MDI in treatment period 2. There will be a washout period between the treatment periods.

Primary Outcome Measure

Number of participants with adverse events (AEs) [ Time Frame: Up to 8 weeks ]

Central Contacts

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