Brief Title
A Phase II , Placebo-controlled Study to Assess Efficacy of 28 Day Oral AZD9668 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 AZD9668 in Patients With Bronchiectasis
Brief Summary
The purpose of this study is to investigate if treatment with AZD9668 for 28 days is effective in treating Bronchiectasis (Brx) and if so how it compares to placebo (a substance which does not have any action).
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Ratio of Absolute Neutrophil Count at End of Treatment Compared to Baseline
Secondary Outcome
Ratio of Tumour Necrosis Factor Alpha (TNF α) at End of Treatment Compared to Baseline
Condition
Bronchiectasis
Intervention
AZD9668
Study Arms / Comparison Groups
AZD9668 active treatment
Description:
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
38
Start Date
September 2008
Completion Date
April 2009
Primary Completion Date
April 2009
Eligibility Criteria
Inclusion Criteria: - Female of non child bearing potential - Clinical diagnosis of bronchiectasis - Be sputum producers, with history of chronic expectoration on most days Exclusion Criteria: - Concomitant diagnosis of pulmonary disease other than bronchiectasis or COPD - FEV1 of <30% of predicted normal
Gender
All
Ages
18 Years - 80 Years
Accepts Healthy Volunteers
No
Contacts
Stockley, Prof, ,
Location Countries
Canada
Location Countries
Canada
Administrative Informations
NCT ID
NCT00769119
Organization ID
D0520C00010
Responsible Party
Sponsor
Study Sponsor
AstraZeneca
Study Sponsor
Stockley, Prof, Principal Investigator, Queen Elizabeth Hospital, Birmingham, England
Verification Date
August 2012