14729-D9831C00002- 1 Month Biopsy Study

Phase 2

Completed

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Drug: AZD1981; Drug: Placebo

• Registration Number: NCT00766415
• Lead Sponsor: AstraZeneca

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-10-03
• Study First Submitted QC: 2008-10-03
• Study First Posted: 2008-10-06
• Study Start: 2008-11
• Study Completion: 2009-06
• Results First Submitted: 2010-11-30
• Status Verified: 2014-01
• Results First Submitted QC: 2014-01-27
• Last Update Submitted: 2014-01-27
• Results First Posted: 2014-02-28
• Last Update Posted: 2014-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AZD1981	AZD1981	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Aggregated Pathology Score	Before and after 1 month treatment	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 (%)	Before and after 1 month treatment	Change in Bronchoalveolar Lavage (BAL): Eosinophil count (% of total) from baseline
Bronchoalveolar Lavage (BAL): Neutrophil Count (%)	Before and after 1 month treatment	Change in Bronchoalveolar Lavage (BAL): Neutrophil count (% of total) from baseline
Bronchoalveolar Lavage (BAL): Macrophages Count (%)	Before and after 1 month treatment	Change in Bronchoalveolar Lavage (BAL): Macrophages count (% of total) from baseline
Bronchoalveolar Lavage (BAL): Lymphocytes Count (%)	Before and after 1 month treatment	Change in Bronchoalveolar Lavage (BAL): Lymphocytes count (% of total) from baseline
Bronchoalveolar Lavage (BAL): Epithelial Cells Count (%)	Before and after 1 month treatment	Change in Bronchoalveolar Lavage (BAL): Epithelial cells count (% of total) from baseline
Bronchoalveolar Lavage (BAL): Total Cells Count	Before and after 1 month treatment	Change in Bronchoalveolar Lavage (BAL): Total cells count from baseline
Induced Sputum: Eosinophil Count (%)	Before and after 3 week treatment	Change in Induced sputum Eosinophil count (% of total) from baseline
Induced Sputum: Neutrophils Count (%)	Before and after 3 week treatment	Change in Induced sputum Neutrophils count (% of total) from baseline
Induced Sputum: Macrophages Count (%)	Before and after 3 week treatment	Change in Induced sputum Macrophages count (% of total) from baseline
Induced Sputum: Lymphocytes Count (%)	Before and after 3 week treatment	Change in Induced sputum Lymphocytes count (% of total) from baseline
Induced Sputum: Epithelial Cells Count (%)	Before and after 3 week treatment	Change in Induced sputum Epithelial cells count (% of total) from baseline
Induced Sputum: Total Cells Count	Before and after 3 week treatment	Change in Induced sputum Total cells count from baseline

Secondary Outcome Measures

Name	Time	Method
Forced Expiratory Volume in 1 Second (FEV1)	Before and after 1 month treatment	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)	Before and after 1 month treatment	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	Before and after 1 month treatment	Mean change in Peak Expiratory Flow (PEF) morning from baseline to the average of the treatment period
Peak Expiratory Flow (PEF) Evening	Before and after 1 month treatment	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	Before and after 1 month treatment	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	Before and after 1 month treatment	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	Before and after 1 month treatment	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	Before and after 1 month treatment	Mean change in COPD symptom sputum score from baseline to the average of the treatment period. 0= (none) - 4= (severe).
Adverse Event (AE)	1 month	Number of participants with an Adverse Event

Trial Locations

Locations (1)

Research Site; 🇬🇧 Newcastle upon Tyne, United Kingdom