Evaluation of the Effect of AZD5069 in Patients With Bronchiectasis

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 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

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