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)
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- AstraZeneca
- Enrollment
- 52
- Locations
- 1
- Primary Endpoint
- Aggregated Pathology Score
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 40 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
AZD1981
Intervention: AZD1981 (Drug)
Placebo
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Aggregated Pathology Score
Time Frame: 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 (%)
Time Frame: Before and after 1 month treatment
Change in Bronchoalveolar Lavage (BAL): Eosinophil count (% of total) from baseline
Bronchoalveolar Lavage (BAL): Neutrophil Count (%)
Time Frame: Before and after 1 month treatment
Change in Bronchoalveolar Lavage (BAL): Neutrophil count (% of total) from baseline
Bronchoalveolar Lavage (BAL): Macrophages Count (%)
Time Frame: Before and after 1 month treatment
Change in Bronchoalveolar Lavage (BAL): Macrophages count (% of total) from baseline
Bronchoalveolar Lavage (BAL): Lymphocytes Count (%)
Time Frame: Before and after 1 month treatment
Change in Bronchoalveolar Lavage (BAL): Lymphocytes count (% of total) from baseline
Bronchoalveolar Lavage (BAL): Epithelial Cells Count (%)
Time Frame: Before and after 1 month treatment
Change in Bronchoalveolar Lavage (BAL): Epithelial cells count (% of total) from baseline
Bronchoalveolar Lavage (BAL): Total Cells Count
Time Frame: Before and after 1 month treatment
Change in Bronchoalveolar Lavage (BAL): Total cells count from baseline
Induced Sputum: Eosinophil Count (%)
Time Frame: Before and after 3 week treatment
Change in Induced sputum Eosinophil count (% of total) from baseline
Induced Sputum: Neutrophils Count (%)
Time Frame: Before and after 3 week treatment
Change in Induced sputum Neutrophils count (% of total) from baseline
Induced Sputum: Macrophages Count (%)
Time Frame: Before and after 3 week treatment
Change in Induced sputum Macrophages count (% of total) from baseline
Induced Sputum: Lymphocytes Count (%)
Time Frame: Before and after 3 week treatment
Change in Induced sputum Lymphocytes count (% of total) from baseline
Induced Sputum: Epithelial Cells Count (%)
Time Frame: Before and after 3 week treatment
Change in Induced sputum Epithelial cells count (% of total) from baseline
Induced Sputum: Total Cells Count
Time Frame: Before and after 3 week treatment
Change in Induced sputum Total cells count from baseline
Secondary Outcomes
- Forced Expiratory Volume in 1 Second (FEV1)(Before and after 1 month treatment)
- Clinical Chronic Obstructive Pulmonary Disease (COPD) The Clinical COPD Questionnaire (CCQ)(Before and after 1 month treatment)
- Peak Expiratory Flow (PEF) Morning(Before and after 1 month treatment)
- Peak Expiratory Flow (PEF) Evening(Before and after 1 month treatment)
- Chronic Obstructive Pulmonary Disease (COPD) Symptom Night-time Awakenings Score(Before and after 1 month treatment)
- Chronic Obstructive Pulmonary Disease (COPD) Symptom Breathing Score(Before and after 1 month treatment)
- Chronic Obstructive Pulmonary Disease (COPD) Symptom Cough Score(Before and after 1 month treatment)
- Chronic Obstructive Pulmonary Disease (COPD) Symptom Sputum Score(Before and after 1 month treatment)
- Adverse Event (AE)(1 month)