drugset / Trial / NCT06261957

A Study to Assess and Compare Safety and Tolerability of 3 Months Treatment With Salbutamol Administered Via MDI Containing Propellant HFA-152a or HFA-134a in Participants ≥ 18 Years of Age With Asthma

NCT06261957 ↗

Phase 3 Completed 471 enrolled GlaxoSmithKline
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The goal of this study is to assess and compare the safety and tolerability of salbutamol administered via metered dose inhaler (MDI) containing propellant 1,1-difluoroethane (HFA-152a) or 1,1,1,2-tetrafluoroethane (HFA-134a) in participants aged \>=18 years with asthma

Timeline

Start
2024-05-31
Primary completion
2025-09-02
Completion
2025-09-02

Outcome

Met primary endpoint

release “formulation of salbutamol MDI containing an innovative low carbon propellant HFA-152a shows therapeutic equivalence and is comparable in safety” gsk.com ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Salbutamol Unknown 100 ug Other

Indications