RecruitingPhase 1NCT06433921

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

A Phase 1, Randomized, 2-part, 7-way Cross-over (Part 1) and 7-way Cross-over (Part 2), Blinded, Single Dose Study in Mild Asthmatics Aged 18-65 to Assess the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers Containing Propellants HFA-152a (Test) and HFA-134a (Reference) Via Methacholine Bronchoprovocation and Systemic Pharmacodynamic Effects


Sponsor

GlaxoSmithKline

Enrollment

84 participants

Start Date

Aug 14, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two versions of a common asthma reliever inhaler (salbutamol, also known as albuterol) that use different propellant gases — one older formulation and one newer, more environmentally friendly option — to see if they work equally well for people with mild asthma. **You may be eligible if...** - You are between 18 and 65 years old - You weigh at least 50 kg and have a BMI between 19 and 35 - You have had asthma for at least 6 months - You are currently on a stable, low-dose asthma treatment (either a short-acting reliever only, or a low-dose inhaled steroid with or without a reliever) - Your treatment dose has been stable for at least 12 weeks **You may NOT be eligible if...** - You have moderate or severe asthma requiring higher-dose medications - You have other significant lung, heart, or other health conditions - You are pregnant or breastfeeding - You have had a severe asthma attack requiring hospital care recently Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSalbutamol HFA-152a

A single 100, 200 or 400 μg dose, given as 1, 2 or 4 × 100 μg actuations (exvalve) at 20 second intervals.

DRUGSalbutamol HFA-134a

A single 100, 200 or 400 μg dose, given as 1, 2 or 4 × 100 μg actuations (exvalve) at 20 second intervals.

DRUGPlacebo

A single placebo HFA-152a suspension or placebo HFA-134a suspension dose, given as at 20 second intervals.


Locations(1)

GSK Investigational Site

Manchester, United Kingdom

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NCT06433921


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