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.

AstraZeneca AB0 个研究点目标入组 60 人开始时间: 2010年8月26日最近更新: 2013年6月17日

适应症

试验速览

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•1Male, or female of non-child bearing potential; ie, women who are permanently or surgically sterilised or post-menopausal.
•2Aged 18 to 80 years inclusive at screening (Visit 1)
•3Have a clinical diagnosis of idiopathic or post infective bronchiectasis as diagnosed with a historical high resolution computerised tomography (HRCT) or bronchogram
•4Be 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.
•5Be 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

•1Any clinically significant disease or disorder
•2Patients with other latent or chronic infections or at risk of infection within 90 days before Visit 2
•3An acute exacerbation or acute respiratory infection (upper or lower) requiring oral steroids or antibiotics within 30 days prior to Visit 2
•4An FEV1 of <30% of predicted normal at Visit 1
•5Patients who have received live or live-attenuated vaccine in the 2 weeks prior to dosing (Visit 2)
•6Concomitant diagnosis of significant pulmonary disease other than bronchiectasis or COPD, including symptomatic asthma and allergic bronchopulmonary aspergillosis
•7Bronchiectasis associated with a generalised immunodeficiency disorder, where manifestations other than bronchiectasis predominate

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