14729-D9831C00002- 1 Month Biopsy Study
Biopsy
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)
1 other identifier
interventional
52
3 countries
8
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 chronic-obstructive-pulmonary-disease
Started Nov 2008
Shorter than P25 for phase_2 chronic-obstructive-pulmonary-disease
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 3, 2008
CompletedFirst Posted
Study publicly available on registry
October 6, 2008
CompletedStudy Start
First participant enrolled
November 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2009
CompletedResults Posted
Study results publicly available
February 28, 2014
CompletedFebruary 28, 2014
January 1, 2014
October 3, 2008
November 30, 2010
January 27, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (13)
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.
Before and after 1 month treatment
Bronchoalveolar Lavage (BAL): Eosinophil Count (%)
Change in Bronchoalveolar Lavage (BAL): Eosinophil count (% of total) from baseline
Before and after 1 month treatment
Bronchoalveolar Lavage (BAL): Neutrophil Count (%)
Change in Bronchoalveolar Lavage (BAL): Neutrophil count (% of total) from baseline
Before and after 1 month treatment
Bronchoalveolar Lavage (BAL): Macrophages Count (%)
Change in Bronchoalveolar Lavage (BAL): Macrophages count (% of total) from baseline
Before and after 1 month treatment
Bronchoalveolar Lavage (BAL): Lymphocytes Count (%)
Change in Bronchoalveolar Lavage (BAL): Lymphocytes count (% of total) from baseline
Before and after 1 month treatment
Bronchoalveolar Lavage (BAL): Epithelial Cells Count (%)
Change in Bronchoalveolar Lavage (BAL): Epithelial cells count (% of total) from baseline
Before and after 1 month treatment
Bronchoalveolar Lavage (BAL): Total Cells Count
Change in Bronchoalveolar Lavage (BAL): Total cells count from baseline
Before and after 1 month treatment
Induced Sputum: Eosinophil Count (%)
Change in Induced sputum Eosinophil count (% of total) from baseline
Before and after 3 week treatment
Induced Sputum: Neutrophils Count (%)
Change in Induced sputum Neutrophils count (% of total) from baseline
Before and after 3 week treatment
Induced Sputum: Macrophages Count (%)
Change in Induced sputum Macrophages count (% of total) from baseline
Before and after 3 week treatment
Induced Sputum: Lymphocytes Count (%)
Change in Induced sputum Lymphocytes count (% of total) from baseline
Before and after 3 week treatment
Induced Sputum: Epithelial Cells Count (%)
Change in Induced sputum Epithelial cells count (% of total) from baseline
Before and after 3 week treatment
Induced Sputum: Total Cells Count
Change in Induced sputum Total cells count from baseline
Before and after 3 week treatment
Secondary Outcomes (9)
Forced Expiratory Volume in 1 Second (FEV1)
Before and after 1 month treatment
Clinical Chronic Obstructive Pulmonary Disease (COPD) The Clinical COPD Questionnaire (CCQ)
Before and after 1 month treatment
Peak Expiratory Flow (PEF) Morning
Before and after 1 month treatment
Peak Expiratory Flow (PEF) Evening
Before and after 1 month treatment
Chronic Obstructive Pulmonary Disease (COPD) Symptom Night-time Awakenings Score
Before and after 1 month treatment
- +4 more secondary outcomes
Study Arms (2)
AZD1981
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Men or women 40 years or above
- FEV1 between 40 and 80% of predicted normal value post-bronchodilator
- Clinical diagnosis of COPD
You may not qualify if:
- Other clinically relevant disease or disorders
- Exacerbation of COPD within 30 days
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (8)
Research Site
Frieburg, Germany
Research Site
Großhansdorf, Germany
Research Site
Hanover, Germany
Research Site
Amsterdam, Netherlands
Research Site
Leicester, United Kingdom
Research Site
London, United Kingdom
Research Site
Manchester, United Kingdom
Research Site
Newcastle upon Tyne, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Alison Holt
- Organization
- AstraZeneca
Study Officials
- PRINCIPAL INVESTIGATOR
Norbert Krug
Fraunhofer Institute
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 3, 2008
First Posted
October 6, 2008
Study Start
November 1, 2008
Study Completion
June 1, 2009
Last Updated
February 28, 2014
Results First Posted
February 28, 2014
Record last verified: 2014-01