A Phase II , Placebo-controlled Study to Assess Efficacy of 28 Day Oral AZD9668 in Patients With Bronchiectasis

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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