Status:
COMPLETED
Evaluation of the Effect of AZD5069 in Patients With Bronchiectasis
Lead Sponsor:
AstraZeneca
Conditions:
Bronchiectasis
Lung Disease
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to investigate the effect of AZD5069 in patients with bronchiectasis.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
83 Patients enrolled
Trial Details
Trial ID
NCT01255592
Start Date
February 1 2011
End Date
February 1 2012
Last Update
October 8 2015
Active Locations (15)
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1
Research Site
Ostrava, Czechia
2
Research Site
Prague, Czechia
3
Research Site
Krakow, Poland
4
Research Site
Lodz, Poland