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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AZD1981 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD1981 | Drug | Oral tablet, twice daily, 4 weeks treatment |
| |
| Placebo |
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Norbert Krug | Fraunhofer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Frieburg | Germany | ||||
| Research Site |
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| Label | URL |
|---|---|
| Related Info | View source |
| CSR-D9831C00002.pdf | View source |
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84 patients enrolled, 52 were randomised, 1 patient discontinued before treatment start and 51 patients completed the study. First patient entered the study on 17 November 2008 and the last patient finished the study on 10 June 2009.
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| ID | Title | Description |
|---|---|---|
| FG000 | AZD1981 | AZD1981 1000 mg, twice daily |
| FG001 | Placebo | Placebo, twice daily |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
One patient randomised to the placebo group voluntarily discontinued from the study after randomisation before receiving any investigational product. This patient is excluded from the analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | AZD1981 | AZD1981 1000 mg, twice daily |
| BG001 | Placebo | Placebo, twice daily |
| BG002 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 1 participant discontinued immediately following randomization, did not start treatment and have not been included in any of the efficacy or safety calculations. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Efficacy analyses were performed on the full-analysis set, comprised of 51 patients: 25 in the AZD1981 group and 26 in the placebo group. However, not all patients will have valid, non-missing values for a given outcome measure. | Posted | Mean | 95% Confidence Interval | Score on a scale | Before and after 1 month treatment |
|
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1 participant discontinued immediately following randomization, did not start treatment and have not been included in any of the efficacy or safety calculations.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AZD1981 | AZD1981 1000 mg, twice daily |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypoxia After Bronchoscopy | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alison Holt | AstraZeneca | ClinicalTrialTransparency@astrazeneca.com |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| C569518 | AZD1981 |
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| Drug |
Placebo |
|
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 |
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 |
| Großhansdorf |
| Germany |
| Research Site | Hanover | Germany |
| Research Site | Amsterdam | Netherlands |
| Research Site | Leicester | United Kingdom |
| Research Site | London | United Kingdom |
| Research Site | Manchester | United Kingdom |
| Research Site | Newcastle upon Tyne | United Kingdom |
| Total |
Total of all reporting groups |
| Mean |
| Full Range |
| Years |
|
| Sex: Female, Male | 1 participant discontinued immediately following randomization, did not start treatment and have not been included in any of the efficacy or safety calculations. | Count of Participants | Participants |
|
Placebo, twice daily |
|
|
| Primary | Bronchoalveolar Lavage (BAL): Eosinophil Count (%) | Change in Bronchoalveolar Lavage (BAL): Eosinophil count (% of total) from baseline | Efficacy analyses were performed on the full-analysis set, comprised of 51 patients: 25 in the AZD1981 group and 26 in the placebo group. However, not all patients will have valid, non-missing values for a given outcome measure. | Posted | Mean | 95% Confidence Interval | percentage | Before and after 1 month treatment |
|
|
|
| Primary | Bronchoalveolar Lavage (BAL): Neutrophil Count (%) | Change in Bronchoalveolar Lavage (BAL): Neutrophil count (% of total) from baseline | Efficacy analyses were performed on the full-analysis set, comprised of 51 patients: 25 in the AZD1981 group and 26 in the placebo group. However, not all patients will have valid, non-missing values for a given outcome measure. | Posted | Mean | 95% Confidence Interval | percentage | Before and after 1 month treatment |
|
|
|
| Primary | Bronchoalveolar Lavage (BAL): Macrophages Count (%) | Change in Bronchoalveolar Lavage (BAL): Macrophages count (% of total) from baseline | Efficacy analyses were performed on the full-analysis set, comprised of 51 patients: 25 in the AZD1981 group and 26 in the placebo group. However, not all patients will have valid, non-missing values for a given outcome measure. | Posted | Mean | 95% Confidence Interval | percentage | Before and after 1 month treatment |
|
|
|
| Primary | Bronchoalveolar Lavage (BAL): Lymphocytes Count (%) | Change in Bronchoalveolar Lavage (BAL): Lymphocytes count (% of total) from baseline | Efficacy analyses were performed on the full-analysis set, comprised of 51 patients: 25 in the AZD1981 group and 26 in the placebo group. However, not all patients will have valid, non-missing values for a given outcome measure. | Posted | Mean | 95% Confidence Interval | percentage | Before and after 1 month treatment |
|
|
|
| Primary | Bronchoalveolar Lavage (BAL): Epithelial Cells Count (%) | Change in Bronchoalveolar Lavage (BAL): Epithelial cells count (% of total) from baseline | Efficacy analyses were performed on the full-analysis set, comprised of 51 patients: 25 in the AZD1981 group and 26 in the placebo group. However, not all patients will have valid, non-missing values for a given outcome measure. | Posted | Mean | 95% Confidence Interval | percentage | Before and after 1 month treatment |
|
|
|
| Primary | Bronchoalveolar Lavage (BAL): Total Cells Count | Change in Bronchoalveolar Lavage (BAL): Total cells count from baseline | Efficacy analyses were performed on the full-analysis set, comprised of 51 patients: 25 in the AZD1981 group and 26 in the placebo group. However, not all patients will have valid, non-missing values for a given outcome measure. | Posted | Mean | 95% Confidence Interval | 10^6/g | Before and after 1 month treatment |
|
|
|
| Primary | Induced Sputum: Eosinophil Count (%) | Change in Induced sputum Eosinophil count (% of total) from baseline | Efficacy analyses were performed on the full-analysis set, comprised of 51 patients: 25 in the AZD1981 group and 26 in the placebo group. However, not all patients will have valid, non-missing values for a given outcome measure. | Posted | Mean | 95% Confidence Interval | percentage | Before and after 3 week treatment |
|
|
|
| Primary | Induced Sputum: Neutrophils Count (%) | Change in Induced sputum Neutrophils count (% of total) from baseline | Efficacy analyses were performed on the full-analysis set, comprised of 51 patients: 25 in the AZD1981 group and 26 in the placebo group. However, not all patients will have valid, non-missing values for a given outcome measure. | Posted | Mean | 95% Confidence Interval | percentage | Before and after 3 week treatment |
|
|
|
| Primary | Induced Sputum: Macrophages Count (%) | Change in Induced sputum Macrophages count (% of total) from baseline | Efficacy analyses were performed on the full-analysis set, comprised of 51 patients: 25 in the AZD1981 group and 26 in the placebo group. However, not all patients will have valid, non-missing values for a given outcome measure. | Posted | Mean | 95% Confidence Interval | percentage | Before and after 3 week treatment |
|
|
|
| Primary | Induced Sputum: Lymphocytes Count (%) | Change in Induced sputum Lymphocytes count (% of total) from baseline | Efficacy analyses were performed on the full-analysis set, comprised of 51 patients: 25 in the AZD1981 group and 26 in the placebo group. However, not all patients will have valid, non-missing values for a given outcome measure. | Posted | Mean | 95% Confidence Interval | percentage | Before and after 3 week treatment |
|
|
|
| Primary | Induced Sputum: Epithelial Cells Count (%) | Change in Induced sputum Epithelial cells count (% of total) from baseline | Efficacy analyses were performed on the full-analysis set, comprised of 51 patients: 25 in the AZD1981 group and 26 in the placebo group. However, not all patients will have valid, non-missing values for a given outcome measure. | Posted | Mean | 95% Confidence Interval | percentage | Before and after 3 week treatment |
|
|
|
| Primary | Induced Sputum: Total Cells Count | Change in Induced sputum Total cells count from baseline | Efficacy analyses were performed on the full-analysis set, comprised of 51 patients: 25 in the AZD1981 group and 26 in the placebo group. However, not all patients will have valid, non-missing values for a given outcome measure. | Posted | Mean | 95% Confidence Interval | 10^6/g | Before and after 3 week treatment |
|
|
|
| Secondary | Forced Expiratory Volume in 1 Second (FEV1) | Change in Forced Expiratory Volume in 1 second (FEV1) from baseline to end of treatment | Efficacy analyses were performed on the full-analysis set, comprised of 51 patients: 25 in the AZD1981 group and 26 in the placebo group. However, not all patients will have valid, non-missing values for a given outcome measure. | Posted | Mean | 95% Confidence Interval | percentage change | Before and after 1 month treatment |
|
|
|
| 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) | Efficacy analyses were performed on the full-analysis set, comprised of 51 patients: 25 in the AZD1981 group and 26 in the placebo group. However, not all patients will have valid, non-missing values for a given outcome measure. | Posted | Mean | 95% Confidence Interval | Scores on a scale | Before and after 1 month treatment |
|
|
|
| Secondary | Peak Expiratory Flow (PEF) Morning | Mean change in Peak Expiratory Flow (PEF) morning from baseline to the average of the treatment period | Efficacy analyses were performed on the full-analysis set, comprised of 51 patients: 25 in the AZD1981 group and 26 in the placebo group. However, not all patients will have valid, non-missing values for a given outcome measure. | Posted | Mean | 95% Confidence Interval | L/min | Before and after 1 month treatment |
|
|
|
| Secondary | Peak Expiratory Flow (PEF) Evening | Mean change in Peak Expiratory Flow (PEF) evening from baseline to the average of the treatment period | Efficacy analyses were performed on the full-analysis set, comprised of 51 patients: 25 in the AZD1981 group and 26 in the placebo group. However, not all patients will have valid, non-missing values for a given outcome measure. | Posted | Mean | 95% Confidence Interval | L/min | Before and after 1 month treatment |
|
|
|
| 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) | Efficacy analyses were performed on the full-analysis set, comprised of 51 patients: 25 in the AZD1981 group and 26 in the placebo group. However, not all patients will have valid, non-missing values for a given outcome measure. | Posted | Mean | 95% Confidence Interval | Score on a scale | Before and after 1 month treatment |
|
|
|
| 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). | Efficacy analyses were performed on the full-analysis set, comprised of 51 patients: 25 in the AZD1981 group and 26 in the placebo group. However, not all patients will have valid, non-missing values for a given outcome measure. | Posted | Mean | 95% Confidence Interval | Score on a scale | Before and after 1 month treatment |
|
|
|
| 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) | Efficacy analyses were performed on the full-analysis set, comprised of 51 patients: 25 in the AZD1981 group and 26 in the placebo group. However, not all patients will have valid, non-missing values for a given outcome measure. | Posted | Mean | 95% Confidence Interval | Score on a scale | Before and after 1 month treatment |
|
|
|
| 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). | Efficacy analyses were performed on the full-analysis set, comprised of 51 patients: 25 in the AZD1981 group and 26 in the placebo group. However, not all patients will have valid, non-missing values for a given outcome measure. | Posted | Mean | 95% Confidence Interval | Score on a scale | Before and after 1 month treatment |
|
|
|
| Secondary | Adverse Event (AE) | Number of participants with an Adverse Event | Posted | Number | Participants | 1 month |
|
|
|
| 1 |
| 25 |
| 5 |
| 25 |
| EG001 | Placebo | Placebo, twice daily | 0 | 26 | 7 | 26 |
| Headache | Nervous system disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Non-systematic Assessment |
|
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| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |