Evaluation of the Effect of AZD5069 in Patients With Bronchiectasis

• Status: Completed
• Trial end date: 2012-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca

Criteria

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