Evaluation of the Effect of AZD5069 in Patients With Bronchiectasis
NCT ID: NCT01255592
Last Updated: 2015-10-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
83 participants
INTERVENTIONAL
2011-02-28
2012-02-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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1
Treatment arm AZD5069
AZD5069
Oral dose bid
2
Placebo dose.
Placebo
Oral dose bid
Interventions
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AZD5069
Oral dose bid
Placebo
Oral dose bid
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Bengt Larsson,, M.B
Role: STUDY_DIRECTOR
AstraZeneca R&D Mölndal
Locations
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Research Site
Ostrava, , Czechia
Research Site
Prague, , Czechia
Research Site
Krakow, , Poland
Research Site
Lodz, , Poland
Research Site
Warsaw, , Poland
Research Site
Hull, East Yorkshire, United Kingdom
Research Site
Leicester, Leicestershire, United Kingdom
Research Site
Birmingham, Wstmid, United Kingdom
Research Site
Belfast, , United Kingdom
Research Site
Bristol, , United Kingdom
Research Site
Cambridge, , United Kingdom
Research Site
London, , United Kingdom
Research Site
Newcastle upon Tyne, , United Kingdom
Research Site
Salford, , United Kingdom
Research Site
Wolverhampton, , United Kingdom
Countries
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Related Links
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Other Identifiers
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D3550C00014
Identifier Type: -
Identifier Source: org_study_id
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