About the study

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.

Who can take part?

You may be eligible to participate in the study if you meet the following criteria:

Inclusion criteria

Lead

1. 18 to 55 years of age inclusive at the time of signing the informed consent at Visit
2. Bodyweight 50 to 120 kg (inclusive) and BMI 18 to 32 kg/m^2 (inclusive) at Visit 1.
3. Documented asthma diagnosis ≥12 months prior to Visit 1.
4. Able to perform acceptable lung function testing for FEV1 according to American Thoracic Society / European Respiratory Society (ATS/ERS) 2019 acceptability criteria.
5. Morning pre
6. bronchodilator (BD) forced expiratory volume (FEV)1 ≥ 40% predicted at Visit 1 and Visit 2.
7. Treated with low dose inhaled corticosteroid plus long-acting β2-agonist (ICS-LABA) or medium-high dose ICS alone or in combination with LABA at a stable dose for at least 3 months prior to Visit 1. Also, treatment with additional asthma controller therapies (eg, LAMA) at a stable dose ≥ 3 months prior to Visit 1 is allowed.
8. Participant's influenza/pneumonia vaccination is up to date as per local guidelines prior to Visit 2. Part 1 and Part 2: Specific

For a full list of inclusion/exclusion criteria, please visit ClinicalTrials.gov

Study locations

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How to apply

Determine if a study site for this clinical trial is near you. Contact the study to apply.