Evaluation of the Effect of AZD5069 in Patients With Bronchiectasis

A Phase II Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy of 28-Day Oral Administration of AZD5069 Twice Daily in Patients With Bronchiectasis

The purpose of this study is to investigate the effect of AZD5069 in patients with bronchiectasis.

Inclusion Criteria:

• Male, or female of non-child bearing potential; ie, women who are permanently or surgically sterilised or post-menopausal.
• Aged 18 to 80 years inclusive at screening (Visit 1)
• Have a clinical diagnosis of idiopathic or post infective bronchiectasis as diagnosed with a historical high resolution computerised tomography (HRCT) or bronchogram
• 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.
• Be on a stable treatment regimen, as judged by the investigator.

Exclusion Criteria:

• Any clinically significant disease or disorder
• Patients with other latent or chronic infections or at risk of infection within 90 days before Visit 2
• An acute exacerbation or acute respiratory infection (upper or lower) requiring oral steroids or antibiotics within 30 days prior to Visit 2
• An FEV1 of <30% of predicted normal at Visit 1
• Patients who have received live or live-attenuated vaccine in the 2 weeks prior to dosing (Visit 2)
• Concomitant diagnosis of significant pulmonary disease other than bronchiectasis or COPD, including symptomatic asthma and allergic bronchopulmonary aspergillosis
• Bronchiectasis associated with a generalised immunodeficiency disorder, where manifestations other than bronchiectasis predominate