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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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).

Detailed Summary:
Sponsor: AstraZeneca

Current Primary Outcome:

  • Ratio of Absolute Neutrophil Count at End of Treatment Compared to Baseline [ Time Frame: End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits. ]
    Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits
  • Ratio of the Percentage Neutrophil Count at End of Treatment Compared to Baseline [ Time Frame: End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits. ]
    Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits
  • 24-hour Sputum Weight(g) [ Time Frame: Baseline and day 28 ]
    Sputum weight (g) collected during 24 hour periods.Change from Baseline to day 28
  • Slow Vital Capacity (SVC) [ Time Frame: Baseline and day 28 ]
    Slow Vital Capacity (L) as a measure of lung function.Change from baseline to day 28
  • Forced Expiratory Volume in 1 Second (FEV1) [ Time Frame: Baseline and day 28 ]
    Forced Expiratory Volume in 1 Second (L) as a measure of lung function.Change from baseline to day 28
  • Forced Vital Capacity (FVC) [ Time Frame: Baseline and day 28 ]
    Forced Vital Capacity (L) as a measure of lung function.Change from baseline to day 28
  • Forced Expiratory Flow Between 25 and 75% of Forced Vital Capacity (FEF25-75%) [ Time Frame: B

    Original Primary Outcome:

    • Absolute and differential neutrophil count in sputum [ Time Frame: Pre and post treatment ]
    • Signs and symptoms of Bronchiectasis [ Time Frame: Throughout the study ]


    Current Secondary Outcome:

    • Ratio of Tumour Necrosis Factor Alpha (TNF α) at End of Treatment Compared to Baseline [ Time Frame: End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits. ]
      Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits
    • Ratio of Interleukin 6 (IL-6) at End of Treatment Compared to Baseline [ Time Frame: End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits. ]
      Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits
    • Ratio of Interleukin 1 Beta (IL-1β) at End of Treatment Compared to Baseline [ Time Frame: End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits. ]
      Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits
    • Ratio of Regulated on Activation, Normal T Cell Expressed and Secreted (RANTES) at End of Treatment Compared to Baseline [ Time Frame: End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits. ]
      Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits
    • Ratio of Monocyte Chemoattractant Protein-1 (MCP-1) at End of Treatment Compared to Baseline [ Time Frame: End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits. ]
      Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits
    • Ratio of Interleukin 8 (IL-8) at End of Treatment Compared to Baseline [ Time Frame: End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits. ]
      Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits
    • Ratio of Leukotriene B4 (LTB4) at End of Treatment Compared to Baseline [ Time Frame: End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits. ]
      Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits
    • Ratio of Urine Desmosine (Free) (Normalised for Creatinine) at End of Treatment Compared to Baseline [ Time Frame: Baseline and day 28 ]
      Ratio of day 28 to baseline
    • Ratio of Urine Desmosine (Total) (Normalised for Creatinine) at End of Treatment Compared to Baseline [ Time Frame: Baseline and day 28 ]
      Ratio of day 28 to baseline


    Original Secondary Outcome:

    • Safety outcome (AE's, labs, etc) [ Time Frame: Throughout the study ]
    • Pharmacokinetic (AZD9668 concentrations in plasma and sputum) [ Time Frame: Day 1 and 28 of treatment ]
    • Pharmacodynamic markers [ Time Frame: Day 1 and 28 of treatment ]


    Information By: AstraZeneca

    Dates:
    Date Received: October 6, 2008
    Date Started: September 2008
    Date Completion:
    Last Updated: August 14, 2012
    Last Verified: August 2012