A Study to Compare the Effects of Two Propellants in Adults With Mild Asthma (NCT05472662) | Clinical Trial Compass
CompletedPhase 2
A Study to Compare the Effects of Two Propellants in Adults With Mild Asthma
United Kingdom25 participantsStarted 2022-08-03
Plain-language summary
This is a Phase IIa, multicentre, single dose, randomised, double blind, controlled, 2 way cross-over study to evaluate the potential for bronchoconstriction of the new HFA-152a propellant (single dose) versus the marketed HFA-134a propellant (single dose) in adults with mild asthma.
HFA=Hydrofluoroalkane
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Subject's written informed consent obtained prior to any study related procedure.
✓. Gender and age: Male or female adults aged from 18 to 75 years old (inclusive).
✓. Diagnosis of asthma: documented established diagnosis of mild asthma for at least 6 months according to Step 1 of the Global Initiative for Asthma (GINA) 2021 guidelines.
✓. Lung function: subjects with a pre-bronchodilator forced expiratory volume in 1 second (FEV1) ≥60% of the predicted normal value and ≥1.5 L at screening and prior to randomisation, after appropriate wash-out from bronchodilators.
✓. Documented excessive variability in lung function.
✓. Current asthma therapy: as needed low-dose inhaled corticosteroids (ICS)-formoterol, as needed short-acting β2-agonists (SABA), or low-dose ICS whenever SABA was taken taken not more than twice a week (2 events) in the 4 weeks prior to screening or in the 6 weeks prior to randomisation.