Study of AZD5718 in uncontrolled Asthma
This is a randomised, placebo-controlled, double-blind study with an active comparator (montelukast) arm to assess the efficacy and safety of AZD5718 administered at multiple dose levels over a 12-week treatment period to adult participants with moderate-to-severe uncontrolled asthma.
It is planned to include 1928 participants.
Actual study start date is January 27, 2022. The researchers expect to complete the study by February 9, 2024.
One primary outcome measure is Time to first CompEx Asthma event (Composite endpoint for Exacerbations), The clinical efficacy of AZD5718 Dose A will be assessed by calculating a Hazard Ratio between the following treatment arms: a) AZD5718 Dose A vs. placebo; b) AZD5718 Dose A vs. Montelukast. CompEx Asthma, a novel composite endpoint for exacerbations, captures asthma-worsening episodes based on a combination of diary events (worsening in daily PEF, asthma symptoms and reliever medication use) plus severe asthma exacerbation events.
Further details can be found here https://ichgcp.net/clinical-trials-registry/NCT05251259.
