NCT06702462

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	HFA-152A propellant	HFA-152A propellant is administered via oral inhalation
DRUG	HFA-134A propellant	HFA-134A propellant is administered via oral inhalation

Timeline

• Start date: 2025-03-11
• Primary completion: 2025-06-04
• Completion: 2025-06-04
• First posted: 2024-11-25
• Last updated: 2025-08-26

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study