A study of test propellant HFA-152a in healthy subjects (QSC302309)
Research type
Research Study
Full title
A randomized, double-blind, single-site, two-way crossover Phase I study to assess the effect of repeated doses of Test propellant (HFA-152a) on mucociliary clearance as compared to Reference propellant (HFA-134a) in healthy male and female participants
IRAS ID
342242
Contact name
Emin Ibrahimov
Contact email
Sponsor organisation
GlaxoSmithKline
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 2 months, 5 days
Research summary
The Sponsor is developing the test product (propellant), HFA-152a, as a potential replacement for the propellant currently used in inhalers to prevent and treat narrowing of the airway that occurs in diseases such as asthma. The current form of the propellant is thought to trap heat from the sun in the atmosphere, contributing to climate change. The new form of propellant is about 10 times less harmful to the atmosphere than the existing form, so its development would be beneficial in reducing the impact of these inhalers on climate change.
In this study, we'll give healthy volunteers repeated doses of the new and existing forms of propellant, to find out their effect on clearance of mucus from the lungs. To do this, volunteers will inhale a solution that contains a small amount of radioactivity (Technetium-99m sulphur colloid) that allows us to measure how fast mucus is cleared from their lungs.
In this study in healthy volunteers, we aim to answer these questions.
*What effect does the test propellant have on the clearance of mucus from the lungs?
*Does the test propellant cause any important side effects?This study will take place at 1 site in Nottingham.
We plan to enrol 24 healthy men and women aged 30-55 years. Volunteers will receive repeated doses of test or existing propellant by inhalation for 7 days in each study part. After their final dose in each study part, volunteers will inhale a solution that contains a radiolabelled substance that will allow us to measure the effects of the propellant on clearance of mucus from the lungs. They'll stay in the clinic for up to 8 nights on 2 occasions, attend 2 outpatient visits, and take up to 8 weeks to finish the study.
We'll collect blood and urine samples to do safety tests.
REC name
Wales REC 2
REC reference
24/WA/0178
Date of REC Opinion
21 Jun 2024
REC opinion
Favourable Opinion