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14729-D9831C00002- 1 Month Biopsy Study (Biopsy)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00766415
Recruitment Status : Completed
First Posted : October 6, 2008
Results First Posted : February 28, 2014
Last Update Posted : February 28, 2014
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

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

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Drug: AZD1981 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)
Study Start Date : November 2008
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: AZD1981 Drug: AZD1981
Oral tablet, twice daily, 4 weeks treatment

Placebo Comparator: Placebo Drug: Placebo
Placebo




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00766415


Locations
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Germany
Research Site
Frieburg, Germany
Research Site
GROßHANSDORF, Germany
Research Site
Hannover, Germany
Netherlands
Research Site
Amsterdam, Netherlands
United Kingdom
Research Site
Leicester, United Kingdom
Research Site
London, United Kingdom
Research Site
Manchester, United Kingdom
Research Site
Newcastle upon Tyne, United Kingdom
Sponsors and Collaborators
AstraZeneca
Investigators
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Principal Investigator: Norbert Krug Fraunhofer Institute
Additional Information:
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00766415    
Other Study ID Numbers: D9831C00002
First Posted: October 6, 2008    Key Record Dates
Results First Posted: February 28, 2014
Last Update Posted: February 28, 2014
Last Verified: January 2014
Keywords provided by AstraZeneca:
COPD
Moderate to severe COPD
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases