14729-D9831C00002- 1 Month Biopsy Study (Biopsy)

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

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Drug: Placebo; Drug: AZD1981

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Phase 2

Contacts and Locations

Study Locations

• Germany
  • Frieburg, Germany
    • Research Site
  • GROßHANSDORF, Germany
    • Research Site
  • Hannover, Germany
    • Research Site
• Netherlands
  • Amsterdam, Netherlands
    • Research Site
• United Kingdom
  • Leicester, United Kingdom
    • Research Site
  • London, United Kingdom
    • Research Site
  • Manchester, United Kingdom
    • Research Site
  • Newcastle upon Tyne, United Kingdom
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Placebo
Experimental: AZD1981	Drug: AZD1981; Oral tablet, twice daily, 4 weeks treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Bronchoalveolar Lavage (BAL): Eosinophil Count (%)	Change in Bronchoalveolar Lavage (BAL): Eosinophil count (% of total) from baseline	Before and after 1 month treatment
Bronchoalveolar Lavage (BAL): Neutrophil Count (%)	Change in Bronchoalveolar Lavage (BAL): Neutrophil count (% of total) from baseline	Before and after 1 month treatment
Bronchoalveolar Lavage (BAL): Macrophages Count (%)	Change in Bronchoalveolar Lavage (BAL): Macrophages count (% of total) from baseline	Before and after 1 month treatment
Bronchoalveolar Lavage (BAL): Lymphocytes Count (%)	Change in Bronchoalveolar Lavage (BAL): Lymphocytes count (% of total) from baseline	Before and after 1 month treatment
Bronchoalveolar Lavage (BAL): Epithelial Cells Count (%)	Change in Bronchoalveolar Lavage (BAL): Epithelial cells count (% of total) from baseline	Before and after 1 month treatment
Bronchoalveolar Lavage (BAL): Total Cells Count	Change in Bronchoalveolar Lavage (BAL): Total cells count from baseline	Before and after 1 month treatment
Induced Sputum: Eosinophil Count (%)	Change in Induced sputum Eosinophil count (% of total) from baseline	Before and after 3 week treatment
Induced Sputum: Neutrophils Count (%)	Change in Induced sputum Neutrophils count (% of total) from baseline	Before and after 3 week treatment
Induced Sputum: Macrophages Count (%)	Change in Induced sputum Macrophages count (% of total) from baseline	Before and after 3 week treatment
Induced Sputum: Lymphocytes Count (%)	Change in Induced sputum Lymphocytes count (% of total) from baseline	Before and after 3 week treatment
Induced Sputum: Epithelial Cells Count (%)	Change in Induced sputum Epithelial cells count (% of total) from baseline	Before and after 3 week treatment
Induced Sputum: Total Cells Count	Change in Induced sputum Total cells count from baseline	Before and after 3 week treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
Adverse Event (AE)	Number of participants with an Adverse Event	1 month

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Principal Investigator: Norbert Krug, Fraunhofer Institute

Publications and helpful links

Helpful Links

• Related Info
• CSR-D9831C00002.pdf

Study record dates

Study Major Dates

• Study Start: November 1, 2008
• Study Completion (Actual): June 1, 2009

Study Registration Dates

• First Submitted: October 3, 2008
• First Submitted That Met QC Criteria: October 3, 2008
• First Posted (Estimate): October 6, 2008

Study Record Updates

• Last Update Posted (Estimate): February 28, 2014
• Last Update Submitted That Met QC Criteria: January 27, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Keywords: COPD; Moderate to severe COPD
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: D9831C00002