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14729-D9831C00002- 1 Month Biopsy Study (Biopsy)

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
AZD1981
Placebo
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD, Moderate to severe COPD

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Men or women 40 years or above
  • FEV1 between 40 and 80% of predicted normal value post-bronchodilator
  • Clinical diagnosis of COPD

Exclusion Criteria:

  • Other clinically relevant disease or disorders
  • Exacerbation of COPD within 30 days

Sites / Locations

  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

AZD1981

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Aggregated Pathology Score
Composite endpoint subscores: histological grade, immunohistochemistry grade, leucocyte counts. Each subscore measured on scale 1 (normal) to 5 (worst outcome). Composite score summed across the subscores, ranging from 3 (normal) to 15 (worst outcome). Change from baseline.
Bronchoalveolar Lavage (BAL): Eosinophil Count (%)
Change in Bronchoalveolar Lavage (BAL): Eosinophil count (% of total) from baseline
Bronchoalveolar Lavage (BAL): Neutrophil Count (%)
Change in Bronchoalveolar Lavage (BAL): Neutrophil count (% of total) from baseline
Bronchoalveolar Lavage (BAL): Macrophages Count (%)
Change in Bronchoalveolar Lavage (BAL): Macrophages count (% of total) from baseline
Bronchoalveolar Lavage (BAL): Lymphocytes Count (%)
Change in Bronchoalveolar Lavage (BAL): Lymphocytes count (% of total) from baseline
Bronchoalveolar Lavage (BAL): Epithelial Cells Count (%)
Change in Bronchoalveolar Lavage (BAL): Epithelial cells count (% of total) from baseline
Bronchoalveolar Lavage (BAL): Total Cells Count
Change in Bronchoalveolar Lavage (BAL): Total cells count from baseline
Induced Sputum: Eosinophil Count (%)
Change in Induced sputum Eosinophil count (% of total) from baseline
Induced Sputum: Neutrophils Count (%)
Change in Induced sputum Neutrophils count (% of total) from baseline
Induced Sputum: Macrophages Count (%)
Change in Induced sputum Macrophages count (% of total) from baseline
Induced Sputum: Lymphocytes Count (%)
Change in Induced sputum Lymphocytes count (% of total) from baseline
Induced Sputum: Epithelial Cells Count (%)
Change in Induced sputum Epithelial cells count (% of total) from baseline
Induced Sputum: Total Cells Count
Change in Induced sputum Total cells count from baseline

Secondary Outcome Measures

Forced Expiratory Volume in 1 Second (FEV1)
Change in Forced Expiratory Volume in 1 second (FEV1) from baseline to end of treatment
Clinical Chronic Obstructive Pulmonary Disease (COPD) The Clinical COPD Questionnaire (CCQ)
Change in total CCQ score from baseline to last measurement on treatment. scored on a scale of 0 - 6. 0 =(low symptoms)-6 =(high symptoms)
Peak Expiratory Flow (PEF) Morning
Mean change in Peak Expiratory Flow (PEF) morning from baseline to the average of the treatment period
Peak Expiratory Flow (PEF) Evening
Mean change in Peak Expiratory Flow (PEF) evening from baseline to the average of the treatment period
Chronic Obstructive Pulmonary Disease (COPD) Symptom Night-time Awakenings Score
Mean change in COPD symptom night-time awakening score from baseline to the average of the treatment period. 0=(no symptom)-4=(no sleep)
Chronic Obstructive Pulmonary Disease (COPD) Symptom Breathing Score
Mean change in COPD symptom breathing score from baseline to the average of the treatment period. 0= (none) - 4 =(severe).
Chronic Obstructive Pulmonary Disease (COPD) Symptom Cough Score
Mean change in COPD symptom cough score from baseline to the average of the treatment period. 0= (none) - 4= (almost constant)
Chronic Obstructive Pulmonary Disease (COPD) Symptom Sputum Score
Mean change in COPD symptom sputum score from baseline to the average of the treatment period. 0= (none) - 4= (severe).
Adverse Event (AE)
Number of participants with an Adverse Event

Full Information

First Posted
October 3, 2008
Last Updated
January 27, 2014
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00766415
Brief Title
14729-D9831C00002- 1 Month Biopsy Study
Acronym
Biopsy
Official Title
A Double-blind, Placebo-controlled, Randomised, Parallel Group Phase IIa Study to Evaluate the Histological Changes, Cellularity, Clinical Efficacy and Safety of AZD1981 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to study histological changes, cellularity, clinical efficacy and safety of AZD1981 in patients with Chronic Obstructive Pulmonary Disease

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
COPD, Moderate to severe COPD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AZD1981
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
AZD1981
Intervention Description
Oral tablet, twice daily, 4 weeks treatment
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Aggregated Pathology Score
Description
Composite endpoint subscores: histological grade, immunohistochemistry grade, leucocyte counts. Each subscore measured on scale 1 (normal) to 5 (worst outcome). Composite score summed across the subscores, ranging from 3 (normal) to 15 (worst outcome). Change from baseline.
Time Frame
Before and after 1 month treatment
Title
Bronchoalveolar Lavage (BAL): Eosinophil Count (%)
Description
Change in Bronchoalveolar Lavage (BAL): Eosinophil count (% of total) from baseline
Time Frame
Before and after 1 month treatment
Title
Bronchoalveolar Lavage (BAL): Neutrophil Count (%)
Description
Change in Bronchoalveolar Lavage (BAL): Neutrophil count (% of total) from baseline
Time Frame
Before and after 1 month treatment
Title
Bronchoalveolar Lavage (BAL): Macrophages Count (%)
Description
Change in Bronchoalveolar Lavage (BAL): Macrophages count (% of total) from baseline
Time Frame
Before and after 1 month treatment
Title
Bronchoalveolar Lavage (BAL): Lymphocytes Count (%)
Description
Change in Bronchoalveolar Lavage (BAL): Lymphocytes count (% of total) from baseline
Time Frame
Before and after 1 month treatment
Title
Bronchoalveolar Lavage (BAL): Epithelial Cells Count (%)
Description
Change in Bronchoalveolar Lavage (BAL): Epithelial cells count (% of total) from baseline
Time Frame
Before and after 1 month treatment
Title
Bronchoalveolar Lavage (BAL): Total Cells Count
Description
Change in Bronchoalveolar Lavage (BAL): Total cells count from baseline
Time Frame
Before and after 1 month treatment
Title
Induced Sputum: Eosinophil Count (%)
Description
Change in Induced sputum Eosinophil count (% of total) from baseline
Time Frame
Before and after 3 week treatment
Title
Induced Sputum: Neutrophils Count (%)
Description
Change in Induced sputum Neutrophils count (% of total) from baseline
Time Frame
Before and after 3 week treatment
Title
Induced Sputum: Macrophages Count (%)
Description
Change in Induced sputum Macrophages count (% of total) from baseline
Time Frame
Before and after 3 week treatment
Title
Induced Sputum: Lymphocytes Count (%)
Description
Change in Induced sputum Lymphocytes count (% of total) from baseline
Time Frame
Before and after 3 week treatment
Title
Induced Sputum: Epithelial Cells Count (%)
Description
Change in Induced sputum Epithelial cells count (% of total) from baseline
Time Frame
Before and after 3 week treatment
Title
Induced Sputum: Total Cells Count
Description
Change in Induced sputum Total cells count from baseline
Time Frame
Before and after 3 week treatment
Secondary Outcome Measure Information:
Title
Forced Expiratory Volume in 1 Second (FEV1)
Description
Change in Forced Expiratory Volume in 1 second (FEV1) from baseline to end of treatment
Time Frame
Before and after 1 month treatment
Title
Clinical Chronic Obstructive Pulmonary Disease (COPD) The Clinical COPD Questionnaire (CCQ)
Description
Change in total CCQ score from baseline to last measurement on treatment. scored on a scale of 0 - 6. 0 =(low symptoms)-6 =(high symptoms)
Time Frame
Before and after 1 month treatment
Title
Peak Expiratory Flow (PEF) Morning
Description
Mean change in Peak Expiratory Flow (PEF) morning from baseline to the average of the treatment period
Time Frame
Before and after 1 month treatment
Title
Peak Expiratory Flow (PEF) Evening
Description
Mean change in Peak Expiratory Flow (PEF) evening from baseline to the average of the treatment period
Time Frame
Before and after 1 month treatment
Title
Chronic Obstructive Pulmonary Disease (COPD) Symptom Night-time Awakenings Score
Description
Mean change in COPD symptom night-time awakening score from baseline to the average of the treatment period. 0=(no symptom)-4=(no sleep)
Time Frame
Before and after 1 month treatment
Title
Chronic Obstructive Pulmonary Disease (COPD) Symptom Breathing Score
Description
Mean change in COPD symptom breathing score from baseline to the average of the treatment period. 0= (none) - 4 =(severe).
Time Frame
Before and after 1 month treatment
Title
Chronic Obstructive Pulmonary Disease (COPD) Symptom Cough Score
Description
Mean change in COPD symptom cough score from baseline to the average of the treatment period. 0= (none) - 4= (almost constant)
Time Frame
Before and after 1 month treatment
Title
Chronic Obstructive Pulmonary Disease (COPD) Symptom Sputum Score
Description
Mean change in COPD symptom sputum score from baseline to the average of the treatment period. 0= (none) - 4= (severe).
Time Frame
Before and after 1 month treatment
Title
Adverse Event (AE)
Description
Number of participants with an Adverse Event
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Men or women 40 years or above FEV1 between 40 and 80% of predicted normal value post-bronchodilator Clinical diagnosis of COPD Exclusion Criteria: Other clinically relevant disease or disorders Exacerbation of COPD within 30 days
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Norbert Krug
Organizational Affiliation
Fraunhofer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Frieburg
Country
Germany
Facility Name
Research Site
City
GROßHANSDORF
Country
Germany
Facility Name
Research Site
City
Hannover
Country
Germany
Facility Name
Research Site
City
Amsterdam
Country
Netherlands
Facility Name
Research Site
City
Leicester
Country
United Kingdom
Facility Name
Research Site
City
London
Country
United Kingdom
Facility Name
Research Site
City
Manchester
Country
United Kingdom
Facility Name
Research Site
City
Newcastle upon Tyne
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=216&filename=CSR-D9831C00002.pdf
Description
Related Info
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=216&filename=CSR-D9831C00002.pdf
Description
CSR-D9831C00002.pdf

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14729-D9831C00002- 1 Month Biopsy Study

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