Chronic Obstructive Pulmonary Disease Clinical Trial
— BiopsyOfficial 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)
The purpose of this study is to study histological changes, cellularity, clinical efficacy and safety of AZD1981 in patients with Chronic Obstructive Pulmonary Disease
Status | Completed |
Enrollment | 52 |
Est. completion date | June 2009 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 40 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Germany | Research Site | Frieburg | |
Germany | Research Site | GROßHANSDORF | |
Germany | Research Site | Hannover | |
Netherlands | Research Site | Amsterdam | |
United Kingdom | Research Site | Leicester | |
United Kingdom | Research Site | London | |
United Kingdom | Research Site | Manchester | |
United Kingdom | Research Site | Newcastle upon Tyne |
Lead Sponsor | Collaborator |
---|---|
AstraZeneca |
Germany, Netherlands, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Primary | Bronchoalveolar Lavage (BAL): Eosinophil Count (%) | Change in Bronchoalveolar Lavage (BAL): Eosinophil count (% of total) from baseline | Before and after 1 month treatment | No |
Primary | Bronchoalveolar Lavage (BAL): Neutrophil Count (%) | Change in Bronchoalveolar Lavage (BAL): Neutrophil count (% of total) from baseline | Before and after 1 month treatment | No |
Primary | Bronchoalveolar Lavage (BAL): Macrophages Count (%) | Change in Bronchoalveolar Lavage (BAL): Macrophages count (% of total) from baseline | Before and after 1 month treatment | No |
Primary | Bronchoalveolar Lavage (BAL): Lymphocytes Count (%) | Change in Bronchoalveolar Lavage (BAL): Lymphocytes count (% of total) from baseline | Before and after 1 month treatment | No |
Primary | Bronchoalveolar Lavage (BAL): Epithelial Cells Count (%) | Change in Bronchoalveolar Lavage (BAL): Epithelial cells count (% of total) from baseline | Before and after 1 month treatment | No |
Primary | Bronchoalveolar Lavage (BAL): Total Cells Count | Change in Bronchoalveolar Lavage (BAL): Total cells count from baseline | Before and after 1 month treatment | No |
Primary | Induced Sputum: Eosinophil Count (%) | Change in Induced sputum Eosinophil count (% of total) from baseline | Before and after 3 week treatment | No |
Primary | Induced Sputum: Neutrophils Count (%) | Change in Induced sputum Neutrophils count (% of total) from baseline | Before and after 3 week treatment | No |
Primary | Induced Sputum: Macrophages Count (%) | Change in Induced sputum Macrophages count (% of total) from baseline | Before and after 3 week treatment | No |
Primary | Induced Sputum: Lymphocytes Count (%) | Change in Induced sputum Lymphocytes count (% of total) from baseline | Before and after 3 week treatment | No |
Primary | Induced Sputum: Epithelial Cells Count (%) | Change in Induced sputum Epithelial cells count (% of total) from baseline | Before and after 3 week treatment | No |
Primary | Induced Sputum: Total Cells Count | Change in Induced sputum Total cells count from baseline | Before and after 3 week treatment | No |
Secondary | 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 | No |
Secondary | 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 | No |
Secondary | 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 | No |
Secondary | 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 | No |
Secondary | 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 | No |
Secondary | 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 | No |
Secondary | 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 | No |
Secondary | 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 | No |
Secondary | Adverse Event (AE) | Number of participants with an Adverse Event | 1 month | No |
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