AZD1419 is planned to be developed as a potential disease-modifying therapy for asthma. Target population is patients with moderate to severe eosinophilic asthma. MedDRA version: 19.0 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Product Name: AZD1419 nebuliser solution 1 - 20 mg/mL
Product Code: AZD1419
Pharmaceutical Form: Nebuliser solution
INN or Proposed INN: Not available
Current Sponsor code: AZD1419
Concentration unit:
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 70 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 70
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of inhaled AZD1419 in eosinophilic asthma patients after withdrawal of controller treatment of ICS + LABA, by evaluating Time to loss of asthma control;Secondary Objective: 1) To further assess the efficacy of inhaled AZD1419 in eosinophilic asthma patients after withdrawal of controller treatment of ICS + LABA, by evaluating: Proportion of patients who experience loss of asthma control Changes over the course of the study in ACQ-5 Changes over the course of the study in asthma daily diary score Changes over the course of the study in number of moderate and severe exacerbations Changes over the course of the study in the use of reliever bronchodilator (short-acting beta-agonist SABA) Changes over the course of the study in pre- and post-bronchodilator FEV1 Changes over the course of the study in PEF Changes over the course of the study in fractional exhaled nitric oxide (FeNO) 2) To evaluate the safety and tolerability of inhaled AZD1419 by assessing Adverse events, vital signs, ECG and laboratory parameters Weekly peak expiratory flow rate (PEFR) and Lung diffusion capacity (DLco) ;Primary end point(s): Time to Loss of asthma control;Timepoint(s) of evaluation of this end point: End of study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Proportion of patients who experience loss of asthma control Changes over the course of the study in ACQ-5 Changes over the course of the study in asthma daily diary score Changes over the course of the study in number of moderate and severe exacerbations Changes over the course of the study in the use of reliever bronchodilator (short-acting beta-agonist SABA) Changes over the course of the study in pre- and post-bronchodilator FEV1 Changes over the course of the study in PEF Changes over the course of the study in fractional exhaled nitric oxide (FeNO) ;Timepoint(s) of evaluation of this end point: End of study | — |
Countries
Denmark, Hungary, Poland, Sweden
Contacts
Public ContactMelanie Curwen
AstraZeneca AB
Outcome results
None listed