Title
14729-D9831C00002- 1 Month Biopsy Study
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)
Phase
Phase 2Lead Sponsor
AstraZenecaStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Chronic Obstructive Pulmonary DiseaseIntervention/Treatment
azd-1981 ...Study Participants
52The purpose of this study is to study histological changes, cellularity, clinical efficacy and safety of AZD1981 in patients with Chronic Obstructive Pulmonary Disease
Oral tablet, twice daily, 4 weeks treatment
Placebo
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
| Event Type | Organ System | Event Term | AZD1981 | Placebo |
|---|
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.
Change in Bronchoalveolar Lavage (BAL): Eosinophil count (% of total) from baseline
Change in Bronchoalveolar Lavage (BAL): Neutrophil count (% of total) from baseline
Change in Bronchoalveolar Lavage (BAL): Macrophages count (% of total) from baseline
Change in Bronchoalveolar Lavage (BAL): Lymphocytes count (% of total) from baseline
Change in Bronchoalveolar Lavage (BAL): Epithelial cells count (% of total) from baseline
Change in Bronchoalveolar Lavage (BAL): Total cells count from baseline
Change in Induced sputum Eosinophil count (% of total) from baseline
Change in Induced sputum Neutrophils count (% of total) from baseline
Change in Induced sputum Macrophages count (% of total) from baseline
Change in Induced sputum Lymphocytes count (% of total) from baseline
Change in Induced sputum Epithelial cells count (% of total) from baseline
Change in Induced sputum Total cells count from baseline
Change in Forced Expiratory Volume in 1 second (FEV1) from baseline to end of 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)
Mean change in Peak Expiratory Flow (PEF) morning from baseline to the average of the treatment period
Mean change in Peak Expiratory Flow (PEF) evening from baseline to the average of the treatment period
Mean change in COPD symptom night-time awakening score from baseline to the average of the treatment period. 0=(no symptom)-4=(no sleep)
Mean change in COPD symptom breathing score from baseline to the average of the treatment period. 0= (none) - 4 =(severe).
Mean change in COPD symptom cough score from baseline to the average of the treatment period. 0= (none) - 4= (almost constant)
Mean change in COPD symptom sputum score from baseline to the average of the treatment period. 0= (none) - 4= (severe).
Number of participants with an Adverse Event
