The purpose of this study is to study histological changes, cellularity, clinical efficacy and safety of AZD1981 in patients with Chronic Obstructive Pulmonary Disease
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
52
Research Site
Frieburg, Germany
Research Site
Großhansdorf, Germany
Research Site
Hanover, Germany
Research Site
Amsterdam, Netherlands
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.
Time frame: Before and after 1 month treatment
Bronchoalveolar Lavage (BAL): Eosinophil Count (%)
Change in Bronchoalveolar Lavage (BAL): Eosinophil count (% of total) from baseline
Time frame: Before and after 1 month treatment
Bronchoalveolar Lavage (BAL): Neutrophil Count (%)
Change in Bronchoalveolar Lavage (BAL): Neutrophil count (% of total) from baseline
Time frame: Before and after 1 month treatment
Bronchoalveolar Lavage (BAL): Macrophages Count (%)
Change in Bronchoalveolar Lavage (BAL): Macrophages count (% of total) from baseline
Time frame: Before and after 1 month treatment
Bronchoalveolar Lavage (BAL): Lymphocytes Count (%)
Change in Bronchoalveolar Lavage (BAL): Lymphocytes count (% of total) from baseline
Time frame: Before and after 1 month treatment
Bronchoalveolar Lavage (BAL): Epithelial Cells Count (%)
Change in Bronchoalveolar Lavage (BAL): Epithelial cells count (% of total) from baseline
Time frame: Before and after 1 month treatment
Bronchoalveolar Lavage (BAL): Total Cells Count
Change in Bronchoalveolar Lavage (BAL): Total cells count from baseline
Time frame: Before and after 1 month treatment
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Research Site
Leicester, United Kingdom
Research Site
London, United Kingdom
Research Site
Manchester, United Kingdom
Research Site
Newcastle upon Tyne, United Kingdom
Induced Sputum: Eosinophil Count (%)
Change in Induced sputum Eosinophil count (% of total) from baseline
Time frame: Before and after 3 week treatment
Induced Sputum: Neutrophils Count (%)
Change in Induced sputum Neutrophils count (% of total) from baseline
Time frame: Before and after 3 week treatment
Induced Sputum: Macrophages Count (%)
Change in Induced sputum Macrophages count (% of total) from baseline
Time frame: Before and after 3 week treatment
Induced Sputum: Lymphocytes Count (%)
Change in Induced sputum Lymphocytes count (% of total) from baseline
Time frame: Before and after 3 week treatment
Induced Sputum: Epithelial Cells Count (%)
Change in Induced sputum Epithelial cells count (% of total) from baseline
Time frame: Before and after 3 week treatment
Induced Sputum: Total Cells Count
Change in Induced sputum Total cells count from baseline
Time frame: Before and after 3 week treatment
Forced Expiratory Volume in 1 Second (FEV1)
Change in Forced Expiratory Volume in 1 second (FEV1) from baseline to end of treatment
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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).
Time frame: 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)
Time frame: 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).
Time frame: Before and after 1 month treatment
Adverse Event (AE)
Number of participants with an Adverse Event
Time frame: 1 month