Clinical trial NCT02898662 (phase 2, status: completed)
Conditions: asthma
ICD codes: J45.998, J82.83, J45.909, J45.991, J45.20, J45.30, J45.40
Drugs: azd1419, placebo
SMILES: CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        Inclusion Criteria:

          -  Male and female patients 18 years and above

          -  Physician-diagnosed asthma requiring treatment with ICS and a long-acting beta agonist
             (LABA). Patients must have taken ICS plus LABA controller medication for at least 3
             months prior to screening

          -  Pre-bronchodilator forced expiratory volume in 1 second (FEV1) ≥50% predicted

          -  Female patients must be 1 year post-menopausal, surgically sterile, or using an
             acceptable method of contraception

          -  Male patients must be surgically sterile or using an acceptable method of
             contraception (defined as barrier methods in conjunction with spermicides) from the
             first dose of the IMP and until 1 month after the last dose of the IMP to prevent
             pregnancy in a partner

          -  Blood eosinophil levels ≥ 250 cells/μL at screening OR a history of blood eosinophil
             levels ≥ 250 cells/μL at any time in the preceding 2 years AND blood eosinophil levels
             ≥ 150 cells /μL at screening. The eosinophilia must be believed to be due to asthma
             and not have other known causes, e.g. helminth infection

          -  ACQ-5 score ≤1.5 at screening

          -  ACQ-5 score ≤0.75 at randomization

          -  Documentation of any of the following within 5 years prior to Visit 1:

               -  Proof of post-bronchodilator reversibility in FEV1 of ≥12% and ≥200 mL

               -  Proof of a positive response to a methacholine or histamine challenge (a decrease
                  in FEV1 by 20% [PC20] at ≤8 mg/mL)

               -  Proof of positive response to mannitol challenge (a decrease in FEV1 by 15%
                  [PD15] at ≤635 mg or a >10% decrease in FEV1 between consecutive doses)

               -  Proof of diurnal variability in PEF >20% over the course of 24 hours in at least
                  4 out of 7 consecutive days If historical documentation is not available, proof
                  of reversibility or a positive response to a methacholine, histamine or mannitol
                  challenge or diurnal variation must be demonstrated according to above and
                  documented during Visit 1

        Exclusion Criteria:

          -  Clinically significant lung disease other than asthma (eg, chronic obstructive
             pulmonary disease, cystic fibrosis, allergic bronchopulmonary aspergillosis, active
             tuberculosis).

          -  History of autoimmune disease including but not limited to Wegener's granulomatosis,
             system lupus erythematosus, rheumatoid arthritis, Sjögren's syndrome, multiple
             sclerosis, autoimmune thrombocytopenia, primary biliary cirrhosis or any other
             autoimmune disease considered clinically relevant by the investigator

          -  Ongoing allergen immunotherapy or plans to begin such therapy during the study period

          -  DLco ≤ 60% of the lower limit of normal

          -  Breast feeding, pregnancy or intention to become pregnant during the course of the
             study

          -  Changes in chest X-ray suggesting clinically significant parenchymal disease other
             than asthma