Brief Title
Evaluation of the Effect of AZD5069 in Patients With Bronchiectasis
Official Title
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
Brief Summary
The purpose of this study is to investigate the effect of AZD5069 in patients with bronchiectasis.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Ratio of Absolute Neutrophil Cell Count in Sputum at End of Treatment Compared to Baseline
Secondary Outcome
Ratio of the Percentage Neutrophil Cell Count in Sputum at End of Treatment Compared to Baseline
Condition
Bronchiectasis
Intervention
AZD5069
Study Arms / Comparison Groups
1
Description: Treatment arm AZD5069
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
83
Start Date
February 2011
Completion Date
February 2012
Primary Completion Date
February 2012
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
Gender
All
Ages
18 Years - 80 Years
Accepts Healthy Volunteers
No
Contacts
Bengt Larsson,, M.B, ,
Location Countries
Czech Republic
Location Countries
Czech Republic
Administrative Informations
NCT ID
NCT01255592
Organization ID
D3550C00014
Responsible Party
Sponsor
Study Sponsor
AstraZeneca
Study Sponsor
Bengt Larsson,, M.B, Study Director, AstraZeneca R&D Mölndal
Verification Date
September 2015