A study to assess the safety and tolerability of low carbon salbutamol MDI in participants 12 years
Research type
Research Study
Full title
A randomized, double-blind, parallel group, multi-center study to evaluate the long-term safety of salbutamol rescue medication when administered via metered dose inhalers containing the propellant HFA-152a or reference HFA-134a
IRAS ID
1009321
Contact name
Jenny Owen
Contact email
Sponsor organisation
GlaxoSmithKline Research & Development Limited
Clinicaltrials.gov Identifier
Research summary
The current propellant in the GlaxoSmithKline (GSK) Salbutamol Metered Dose Inhaler (MDI) is a potent greenhouse gas, which needs to be addressed to reduce the climate impact.
The aim of this study, sponsored by GSK, is to establish the long-term safety of the modified MDI with HFA-152a propellant (study group) compared to the currently approved MDI with HFA-134a propellant (control group) in patients 12 years of age and older with asthma.
By replacing the current propellant with the new alternative propellant of lower global warming potential, GSK will reduce the carbon footprint by a minimum of 90% compared to the currently marketed device.
In the UK about 50 participants will be recruited to this study and will receive active drug. A computer will place participants into either the study group or the control group. Participants are 3 times more likely to be placed in the study group.
Participants will attend a screening visit, a baseline visit for 7 days followed by 5 on-treatment visits at week 0, 1, 4, 8, and 12. Week 2 will be a telephone visit. Participants will receive enough treatment for 3 months of dosing over the course of the study. To ensure adequate exposure to the drug, participants will be instructed to use the inhaler at least once daily and on a as needed basis (up to maximum 800 µg), according to their asthma symptoms in the same manner as their current rescue inhaler. A follow-up contact will be performed one week after completion of the 12-week treatment period.
Participants will be required to give blood for testing, have lung function tests (spirometry) , ECG to check the functioning of the heart as well as complete an electronic diary.
The total duration of the study will be about 13 weeks.REC name
London - West London & GTAC Research Ethics Committee
REC reference
24/LO/0223
Date of REC Opinion
22 Apr 2024
REC opinion
Further Information Favourable Opinion