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The primary aim of this study is to investigate the tolerability and safety of AZD 1236 compared with placebo ("inactive substance") in COPD patients by assessment of Adverse Events, vital signs and laboratory safety assessments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
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| 2 | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD1236 | Drug | oral tablet, 75 mg, twice daily during 6 weeks |
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| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events | Number of patients who had an Adverse Event | all study visits |
| Measure | Description | Time Frame |
|---|---|---|
| Forced Expiratory Volume in 1 Second (FEV1) | Change in FEV1 from baseline to end of treatment | Before treatment and after 1, 2, 4 and 6 weeks of treatment |
| Forced Vital Capacity (FVC) | Change in FVC from baseline to end of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Helgo Magnussen, MD, Professor | Pulmonary research institute at Hospital Grosshansdorf, Wöhrendamm, Grosshansdorf Germany | Principal Investigator |
| Andrew Lockton, MD | AstraZeneca R&D Charnwood | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Rousse | Bulgaria | ||||
| Research Site |
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| ID | Title | Description |
|---|---|---|
| FG000 | AZD1236 | AZD1236 |
| FG001 | Placebo | Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Drug |
Dosing to match AZD1236 |
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| Before treatment and after 1, 2, 4 and 6 weeks of treatment |
| Vital Capacity (VC) | Change in VC from baseline to end of treatment | Before treatment and after 1, 2, 4 and 6 weeks of treatment |
| Inspiratory Capacity (IC) | Change in IC from baseline to end of treatment | Before treatment and after 1, 2, 4 and 6 weeks of treatment |
| Forced Expiratory Flow (FEF)25-75% | Change in FEF from baseline to end of treatment | Before treatment and after 1, 2, 4 and 6 weeks of treatment |
| Peak Expiratory Flow (PEF) Morning | Change in PEF from average during run-in to average during the last 4 w of treatment | Daily during run-in and treatment |
| Peak Expiratory Flow (PEF) Evening | Change in PEF from average during run-in to average during the last 4 w of treatment | Daily during run-in and treatment |
| Clinical Chronic Obstructive Pulmonary Disease (COPD) Questionnaire(CCQ) Total | Change from baseline to end of treatment in score , The total scores vary between 0 (never/not limited at all) to 6 (almost all the time/totally limited) | Before treatment and after 1, 2, 4 and 6 weeks of treatment |
| Clinical Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Breathlessness | Change in COPD symptom, Breathlessness from average during run-in to average during the last 4 w of treatment. 5-point Likert-type scale, ranging from 0 (none) to 4 (severe) | Daily during run-in and treatment |
| Clinical Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Chest Tightness | Change in COPD symptom, chest tightness from average during run-in to average during the last 4 w of treatment, 5-point Likert-type scale, ranging from 0 (none) to 4 (severe) | Daily during run-in and treatment |
| Clinical Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Cough Score | Change in COPD symptoms, cough score from average during run-in to average during the last 4 w of treatment, 5-point Likert-type scale, ranging from 0 (none) to 4 (severe) | Daily during run-in and treatment |
| Clinical Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Night Time Awakenings | Change in night time awakenings from average during run-in to average during the last 4 w of treatment, 5-point Likert-type scale, ranging from 0 (none) to 4 (severe) | Daily during run-in and treatment |
| 6-minute Walk Test | Change from baseline to end of treatment | Before treatment and after 6 weeks of treatment |
| Sofia |
| Bulgaria |
| Research Site | Helsinki | Finland |
| Research Site | Oulu | Finland |
| Research Site | Preitilä | Finland |
| Research Site | Berlin | Germany |
| Research Site | Grobhansdorf | Germany |
| Research Site | Győr | Hungary |
| Research Site | Komló | Hungary |
| Research Site | Pécs | Hungary |
| Research Site | Vásárosnamény | Hungary |
| Research Site | Bojnice | Slovakia |
| Research Site | Liptovský Hrádok | Slovakia |
| Research Site | Žilina | Slovakia |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | AZD1236 | AZD1236 |
| BG001 | Placebo | Placebo |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Full Range | Year |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 | Incidence of Adverse Events | Number of patients who had an Adverse Event | Posted | Number | Participants | all study visits |
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| Secondary | Forced Expiratory Volume in 1 Second (FEV1) | Change in FEV1 from baseline to end of treatment | Posted | Mean | Full Range | L | Before treatment and after 1, 2, 4 and 6 weeks of treatment |
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| Secondary | Forced Vital Capacity (FVC) | Change in FVC from baseline to end of treatment | Posted | Mean | Full Range | L | Before treatment and after 1, 2, 4 and 6 weeks of treatment |
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| Secondary | Vital Capacity (VC) | Change in VC from baseline to end of treatment | Posted | Mean | Full Range | L | Before treatment and after 1, 2, 4 and 6 weeks of treatment |
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| Secondary | Inspiratory Capacity (IC) | Change in IC from baseline to end of treatment | Posted | Mean | Full Range | L | Before treatment and after 1, 2, 4 and 6 weeks of treatment |
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| Secondary | Forced Expiratory Flow (FEF)25-75% | Change in FEF from baseline to end of treatment | Posted | Mean | Full Range | L/s | Before treatment and after 1, 2, 4 and 6 weeks of treatment |
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| Secondary | Peak Expiratory Flow (PEF) Morning | Change in PEF from average during run-in to average during the last 4 w of treatment | Posted | Mean | Full Range | L/min | Daily during run-in and treatment |
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| Secondary | Peak Expiratory Flow (PEF) Evening | Change in PEF from average during run-in to average during the last 4 w of treatment | Posted | Mean | Full Range | L/min | Daily during run-in and treatment |
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| Secondary | Clinical Chronic Obstructive Pulmonary Disease (COPD) Questionnaire(CCQ) Total | Change from baseline to end of treatment in score , The total scores vary between 0 (never/not limited at all) to 6 (almost all the time/totally limited) | Posted | Mean | Full Range | Score on scale | Before treatment and after 1, 2, 4 and 6 weeks of treatment |
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| Secondary | Clinical Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Breathlessness | Change in COPD symptom, Breathlessness from average during run-in to average during the last 4 w of treatment. 5-point Likert-type scale, ranging from 0 (none) to 4 (severe) | Posted | Mean | Full Range | Score on scale | Daily during run-in and treatment |
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| Secondary | Clinical Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Chest Tightness | Change in COPD symptom, chest tightness from average during run-in to average during the last 4 w of treatment, 5-point Likert-type scale, ranging from 0 (none) to 4 (severe) | Posted | Mean | Full Range | Scores on a Scale | Daily during run-in and treatment |
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| Secondary | Clinical Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Cough Score | Change in COPD symptoms, cough score from average during run-in to average during the last 4 w of treatment, 5-point Likert-type scale, ranging from 0 (none) to 4 (severe) | Posted | Mean | Full Range | Scores on a Scale | Daily during run-in and treatment |
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| Secondary | Clinical Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Night Time Awakenings | Change in night time awakenings from average during run-in to average during the last 4 w of treatment, 5-point Likert-type scale, ranging from 0 (none) to 4 (severe) | Posted | Mean | Full Range | Score on scale | Daily during run-in and treatment |
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| Secondary | 6-minute Walk Test | Change from baseline to end of treatment | Posted | Mean | Full Range | m | Before treatment and after 6 weeks of treatment |
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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 | AZD1236 | AZD1236 | 1 | 35 | 8 | 35 | ||
| EG001 | Placebo | Placebo | 0 | 39 | 8 | 39 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pharyngeal Cancer Stage Unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| CHRONIC OBSTRUCTIVE PULMONARY DISEASE | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| HEADACHE | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| VIRAL INFECTION | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gerard Lynch | AstraZeneca | aztrial_results_posting@astrazeneca.com |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000713527 | 4-((5-chloro-2-pyridinyl)oxy)-1-((((4S)-4-methyl-2,5-dioxo-4-imidazolidinyl)methyl)sulfonyl)-piperidine |
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