Bronchiectasis MedDRA version: 12.1 Level: LLT Classification code 10006445 Term: Bronchiectasis
Conditions
Interventions
Product Code: AZD5069
Pharmaceutical Form: Capsule, hard
Current Sponsor code: AZD5069
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
Pharmaceutical form of th
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1 Male, or female of non-child bearing potential; ie, women who are permanently or surgically sterilised or post-menopausal. 2 Aged 18 to 80 years inclusive at screening (Visit 1) 3 Have a clinical diagnosis of idiopathic or post infective bronchiectasis as diagnosed with a historical high resolution computerised tomography (HRCT) or bronchogram 4 Be sputum producers with a history of chronic expectoration on most days of most weeks of the year. Patients should have a history of spontaneously producing sputum on a daily basis and should be able to provide at least 2 of the 3 required baseline sputum samples with an average of 3 mL or more. 5 Be on a stable treatment regimen, as judged by the investigator. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1 Any clinically significant disease or disorder 2 Patients with other latent or chronic infections or at risk of infection within 90 days before Visit 2 3 An acute exacerbation or acute respiratory infection (upper or lower) requiring oral steroids or antibiotics within 30 days prior to Visit 2 4 An FEV1 of <30% of predicted normal at Visit 1 5 Patients who have received live or live-attenuated vaccine in the 2 weeks prior to dosing (Visit 2) 6 Concomitant diagnosis of significant pulmonary disease other than bronchiectasis or COPD, including symptomatic asthma and allergic bronchopulmonary aspergillosis 7 Bronchiectasis associated with a generalised immunodeficiency disorder, where manifestations other than bronchiectasis predominate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the effect of AZD5069 on absolute neutrophil cell count in the sputum of bronchiectasis patients;Secondary Objective: To investigate the effect of AZD5069 on percentage neutrophil cell count in the sputum of bronchiectasis patients. To investigate the effect of AZD5069 on signs and symptoms of bronchiectasis (including effects on quality of life). To investigate the safety and tolerability of 28 days’ dosing with AZD5069 in bronchiectasis patients. ;Primary end point(s): Primary efficacy variable: Absolute neutrophil cell count in sputum | — |
Countries
United Kingdom
Outcome results
None listed