Evaluation of the Effect of AZD5069 in Patients With Bronchiectasis

Launched by ASTRAZENECA · Dec 6, 2010

Keywords

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Gender

ALL

Eligibility 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