FLASH
Research type
Research Study
Full title
A Phase 2, Randomised, Double-Blind, Placebo and Active Comparator-Controlled Study to Assess Efficacy and Safety of Multiple Dose Levels of AZD5718 Given Orally Once Daily for Twelve Weeks in Adults with Moderate-to-Severe Uncontrolled Asthma
IRAS ID
1005185
Contact name
Marnie Duncan
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2021-000338-35
Clinicaltrials.gov Identifier
Research summary
Asthma is a chronic and complex respiratory disease characterised by a range of pathogenic features including inflammation of the lungs, mucus over secretion and variable airway obstruction and structural changes. Asthma affects an estimated 339 million individuals world-wide. Studies have reported a higher asthma prevalence in developed countries compared to low-middle income countries. Despite effective treatments many asthma patients remain at risk of the disease worsening.
AstraZeneca is conducting this study to learn how effective, tolerable, and safe an experimental drug called AZD5718 is in treating participants with asthma. AZD5718 is thought to help in reducing symptoms and frequency of asthma exacerbations (also called flares or asthma worsening). The study also aims to better understand asthma and associated health problems.
The is a double-blind study and will be performed in 2 parts. Both parts will have a screening period, run-in period (participants will be trained on how to use the required inhaled controller medications to ensure that the technique is correct), treatment period and follow-up period.
For Part 1, after the screening and run-in period, participants will be randomly assigned to receive either AZD5718 or a placebo. AZD5718 or placebo, is a tablet that is to be taken orally. The participants will take two tablets once every day for 12 weeks in the morning.
For Part 2, after the screening and run-in period, participants will be randomly assigned to receive either AZD5718 at variable doses, montelukast or a placebo. The participants will take two tablets of AZD5718 or placebo and one capsule of montelukast once every day for 12 weeks in the morning.
Tablets/capsules will be provided for participants to take at home in both parts. Approximately 1928 participants will be randomised globally.
REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
22/EM/0117
Date of REC Opinion
20 Jul 2022
REC opinion
Further Information Favourable Opinion