14729-D9831C00002- 1 Month Biopsy Study

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

Official Title
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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)

Conditions
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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Drug: AZD1981
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AZD1981<br> | Drug: AZD1981<br>* Oral tablet, twice daily, 4 weeks treatment<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Forced Expiratory Volume in 1 Second (FEV1) | Change in Forced Expiratory Volume in 1 second (FEV1) from baseline to end of treatment | Before and after 1 month 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) | Before and after 1 month treatment | 
| Peak Expiratory Flow (PEF) Morning | Mean change in Peak Expiratory Flow (PEF) morning from baseline to the average of the treatment period | Before and after 1 month treatment | 
| Peak Expiratory Flow (PEF) Evening | Mean change in Peak Expiratory Flow (PEF) evening from baseline to the average of the treatment period | Before and after 1 month treatment | 
| 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) | Before and after 1 month treatment | 
| 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). | Before and after 1 month treatment | 
| 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) | Before and after 1 month treatment | 
| 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). | Before and after 1 month treatment | 
| Adverse Event (AE) | Number of participants with an Adverse Event | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD, Moderate to severe COPD