Comparing salbutamol via inhalers containing propellant HFA-152a vs HFA-134a in mild asthmatics
Research type
Research Study
Full title
A Phase 1, randomized, 2-part, 7-way cross-over (Part 1) and 7-way cross-over (Part 2), active device 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.
IRAS ID
1009853
Contact name
Jenny Owen
Contact email
Sponsor organisation
GlaxoSmithKline Research and Development Limited
Eudract number
0000-000000-00
Research summary
In currently marketed Ventolin Inhalers, particles of the Salbutamol are suspended in a propellant named HFA-134a. This propellant has a significant global warming potential, and there is now environmental pressure to replace this with a low carbon footprint alternative. GSK is seeking to develop a low carbon footprint alternative propellant, HFA-152a, which will address global climate change.
This study will compare the strength of response (potency) and variability of response to different doses of salbutamol inhaler with the new HFA-152a propellant (called ‘test) compared to the original salbutamol inhaler with HFA-134a propellant (called ‘reference’) in participants with mild asthma. Participants will undergo a methacholine challenge (a procedure that causes the airways to narrow) to evaluate how reactive or responsive their lungs are after inhaling salbutamol with each propellant. The amount of methacholine inhaled that causes a 20% decrease in the amount of air that participants can forcefully exhale within one second is termed the PC20. Participants will undergo a methacholine challenge, which involves inhaling methacholine to narrow the airways, to test the potency of both test and reference inhalers.
This study is designed to take place in two parts. Participants will be randomly assigned to Part 1 or Part 2. Part 1 will be conducted first, and Part 2 will be initiated based on the results observed in Part 1. In both parts, participants will be randomly assigned to a specific treatment sequence. In each treatment sequence there are 7 treatment periods, meaning 7 visits to attend the site to be given salbutamol HFA-134a, salbutamol HFA-152 and placebo equivalents, followed by a methacholine challenge procedure. Depending on the results from Part 1, Part 2 may no longer be required, meaning the study will stop after Part 1.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
24/NE/0077
Date of REC Opinion
17 May 2024
REC opinion
Further Information Favourable Opinion