drugset / Trial / NCT06433921

A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive

NCT06433921

Phase 1 Recruiting 84 enrolled GlaxoSmithKline
RandomizedCrossoverTriple-blindOther

Summary

The primary objectives of the study are: Part 1: to characterize the potency and variability of dose response on efficacy (Provocative concentration of methacholine causing at least a 20% fall in forced expiratory volume (FEV1) \[PC20\]) of salbutamol administered via MDI with salbutamol HFA-134a or salbutamol HFA-152a in participants with mild asthma. Part 2: to compare the comparative dose response on efficacy (PC20) of salbutamol when administered via MDI with salbutamol HFA-134a or salbutamol HFA-152a in participants with mild asthma.

Timeline

Start
2024-08-14
Primary completion
2027-02-26
Completion
2027-02-26

Drugs

EvaluationDrugModalityDoseRoute
Subject Salbutamol Unknown 100 ug Inhaled
Subject Salbutamol Unknown 200 ug Inhaled
Subject Salbutamol Unknown 400 ug Inhaled

Indications