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Completed

NCT Number: NCT00766415

14729-D9831C00002- 1 Month Biopsy Study

The purpose of this study is to study histological changes, cellularity, clinical efficacy and safety of AZD1981 in patients with Chronic Obstructive Pulmonary Disease

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Frieburg, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AZD1981

Drug

Oral tablet, twice daily, 4 weeks treatment

Placebo

Drug

Placebo

Primary outcomes

  1. 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.

  2. Bronchoalveolar Lavage (BAL): Eosinophil Count (%)

    Time frame: Before and after 1 month treatment

    Change in Bronchoalveolar Lavage (BAL): Eosinophil count (% of total) from baseline

  3. Bronchoalveolar Lavage (BAL): Neutrophil Count (%)

    Time frame: Before and after 1 month treatment

    Change in Bronchoalveolar Lavage (BAL): Neutrophil count (% of total) from baseline

  4. Bronchoalveolar Lavage (BAL): Macrophages Count (%)

    Time frame: Before and after 1 month treatment

    Change in Bronchoalveolar Lavage (BAL): Macrophages count (% of total) from baseline

  5. Bronchoalveolar Lavage (BAL): Lymphocytes Count (%)

    Time frame: Before and after 1 month treatment

    Change in Bronchoalveolar Lavage (BAL): Lymphocytes count (% of total) from baseline

  6. 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

  7. Bronchoalveolar Lavage (BAL): Total Cells Count

    Time frame: Before and after 1 month treatment

    Change in Bronchoalveolar Lavage (BAL): Total cells count from baseline

  8. Induced Sputum: Eosinophil Count (%)

    Time frame: Before and after 3 week treatment

    Change in Induced sputum Eosinophil count (% of total) from baseline

  9. Induced Sputum: Neutrophils Count (%)

    Time frame: Before and after 3 week treatment

    Change in Induced sputum Neutrophils count (% of total) from baseline

  10. Induced Sputum: Macrophages Count (%)

    Time frame: Before and after 3 week treatment

    Change in Induced sputum Macrophages count (% of total) from baseline

  11. Induced Sputum: Lymphocytes Count (%)

    Time frame: Before and after 3 week treatment

    Change in Induced sputum Lymphocytes count (% of total) from baseline

  12. Induced Sputum: Epithelial Cells Count (%)

    Time frame: Before and after 3 week treatment

    Change in Induced sputum Epithelial cells count (% of total) from baseline

  13. Induced Sputum: Total Cells Count

    Time frame: Before and after 3 week treatment

    Change in Induced sputum Total cells count from baseline

Secondary outcomes

  1. Forced Expiratory Volume in 1 Second (FEV1)

    Time frame: Before and after 1 month treatment

    Change in Forced Expiratory Volume in 1 second (FEV1) from baseline to end of treatment

  2. Clinical Chronic Obstructive Pulmonary Disease (COPD) The Clinical COPD Questionnaire (CCQ)

    Time frame: Before and after 1 month 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)

  3. Peak Expiratory Flow (PEF) Morning

    Time frame: Before and after 1 month treatment

    Mean change in Peak Expiratory Flow (PEF) morning from baseline to the average of the treatment period

  4. Peak Expiratory Flow (PEF) Evening

    Time frame: Before and after 1 month treatment

    Mean change in Peak Expiratory Flow (PEF) evening from baseline to the average of the treatment period

  5. Chronic Obstructive Pulmonary Disease (COPD) Symptom Night-time Awakenings Score

    Time frame: Before and after 1 month treatment

    Mean change in COPD symptom night-time awakening score from baseline to the average of the treatment period. 0=(no symptom)-4=(no sleep)

  6. Chronic Obstructive Pulmonary Disease (COPD) Symptom Breathing Score

    Time frame: Before and after 1 month treatment

    Mean change in COPD symptom breathing score from baseline to the average of the treatment period. 0= (none) - 4 =(severe).

  7. Chronic Obstructive Pulmonary Disease (COPD) Symptom Cough Score

    Time frame: Before and after 1 month treatment

    Mean change in COPD symptom cough score from baseline to the average of the treatment period. 0= (none) - 4= (almost constant)

  8. Chronic Obstructive Pulmonary Disease (COPD) Symptom Sputum Score

    Time frame: Before and after 1 month treatment

    Mean change in COPD symptom sputum score from baseline to the average of the treatment period. 0= (none) - 4= (severe).

  9. Adverse Event (AE)

    Time frame: 1 month

    Number of participants with an Adverse Event

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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)

Acronym: Biopsy

Important dates

Study start
2008
Study completion
2009
First posted
Oct 6, 2008
Registry last updated
Feb 28, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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