14729-D9831C00002- 1 Month Biopsy Study

Chronic Obstructive Pulmonary Disease Clinical Trial

— Biopsy  

Official 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00766415
• Other study ID #: D9831C00002
• Status: Completed
• Phase: Phase 2
• First received: October 3, 2008
• Last updated: January 27, 2014
• Start date: November 2008
• Est. completion date: June 2009

Study information

• Verified date: January 2014
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesThe Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: June 2009
• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• AZD1981
Oral tablet, twice daily, 4 weeks treatment
• Placebo
Placebo

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Germany,  Netherlands,  United Kingdom, 

Outcome

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

External Links

•   Link
•   CSR-D9831C00002.pdf