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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


Phase 2
18 Years
80 Years
Not Enrolling
Both
Bronchiectasis

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Outcome Measure:

Ratio of Absolute Neutrophil Count at End of Treatment Compared to Baseline

Outcome Description:

Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits

Outcome Time Frame:

End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.

Safety Issue:

No

Principal Investigator

Stockley, Prof

Investigator Role:

Principal Investigator

Investigator Affiliation:

Queen Elizabeth Hospital, Birmingham, England

Authority:

Canada: Health Canada

Study ID:

D0520C00010

NCT ID:

NCT00769119

Start Date:

September 2008

Completion Date:

April 2009

Related Keywords:

  • Bronchiectasis
  • bronchiectasis
  • Phase II
  • Bronchiectasis

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