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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00769119
First received: October 6, 2008
Last updated: August 14, 2012
Last verified: August 2012
History of Changes
  Purpose

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).


Condition Intervention Phase
Bronchiectasis
 Drug: AZD9668
Drug: Placebo
 Phase 2

Study Type: 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
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

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Sputum weight (g) collected during 24 hour periods.Change from Baseline to day 28

  • Slow Vital Capacity (SVC) [ Time Frame: Baseline and day 28 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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: Baseline and day 28 ] [ Designated as safety issue: No ]
    FEF25-75% as a measure of lung function.Change from baseline to day 28

  • Morning Peak Expiratory Flow (PEF) [ Time Frame: Last 7 days on treatment ] [ Designated as safety issue: No ]
    Morning Peak Expiratory Flow (L/min) as a measure of lung function.Change from mean baseline value to mean of the last 7 days on treatment

  • Evening Peak Expiratory Flow (PEF) [ Time Frame: Last 7 days on treatment ] [ Designated as safety issue: No ]
    Evening Peak Expiratory Flow (L/min) as a measure of lung function.Change from mean baseline value to mean of the last 7 days on treatment

  • Bronkotest Diary Card Signs and Symptoms [ Time Frame: Last 7 days on treatment ] [ Designated as safety issue: No ]
    The Bronkotest diary card includes 8 questions on signs and symptoms. Symptom scores were recorded for night-time symptoms, breathing, sputum colour, sputum amount, sputum type, wellbeing, and cough, generally scored on a scale from 0 (no symptoms) to 4 (worst symptoms). ANOVA models were fitted to compare the change from baseline between AZD9668 and placebo for each question separately, with a p-value of 0.1 considered statistically significant. The number of number of these 8 measures with significant differences is reported.

  • St George's Respiratory Questionnaire for COPD Patients (SGRQ-C) [ Time Frame: Baseline and day 28 ] [ Designated as safety issue: No ]
    SGRQ total score shows the impact of COPD on patient's health status, and expressed as a percentage of impairment with scale from 0 (best health status) to 100 (worst possible status). Change from baseline to day 28.


Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Ratio of day 28 to baseline


Enrollment: 38
Study Start Date: September 2008
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AZD9668 active treatment Drug: AZD9668
2 x 30 mg, oral tablet, twice daily for 28 days
Placebo Comparator: AZD9668 placebo treatment Drug: Placebo
2 x Matched placebo, oral tablet, twice daily for 28 days

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00769119

Locations
Canada, Quebec
Research Site
Chemin Sainte-Foy, Quebec, Canada
Canada
Research Site
Calgary, Canada
Research Site
Montreal, Canada
Research Site
Ontario, Canada
Research Site
Vancouver, Canada
United Kingdom
Research Site
Birmingham, United Kingdom
Research Site
Cambridge, United Kingdom
Research Site
London, United Kingdom
Research Site
New Castle, United Kingdom
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Stockley, Prof Queen Elizabeth Hospital, Birmingham, England
Study Director: Carin Jorup AstraZeneca R&D Lund
  More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00769119     History of Changes
Other Study ID Numbers: D0520C00010
Study First Received: October 6, 2008
Results First Received: January 24, 2012
Last Updated: August 14, 2012
Health Authority: Canada: Health Canada
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by AstraZeneca:
bronchiectasis
Phase II

Additional relevant MeSH terms:
Bronchiectasis
Bronchial Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 22, 2013