Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to see if treatment with AZD4818 for four weeks is tolerable, safe and effective in treating COPD and, if so, how it compares with placebo.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | AZD4818 |
|
| 2 | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD4818 | Drug | Dry Powder, inhalation, b.i.d., 4 weeks |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Experiencing Adverse Events | Number of patients who had an Adverse Event | At all study visits |
| Measure | Description | Time Frame |
|---|---|---|
| Forced Expiratory Volume 1 (FEV1) | Change in (FEV1) from baseline to end of treatment | Before treatment and after 1, 2, 3 and 4 weeks of treatment |
| Forced Vital Capacity (FVC) | Change in FVC from baseline to end of treatment |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Huib AM Kerstjens, MD, PhD | University Medical Centre, Groningen, The Netherlands | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Hvidovre | Denmark | ||||
| Research Site |
Not provided
One participant was excluded in the analysis sets since this participat is non-informative both in terms of efficacy and safety, and was immediately withdrawn for non-treatment related reasons. AZD4818 Turbuhaler group will include 33 patients in all other sections
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | AZD4818 | AZD4818 Turbuhaler |
| FG001 | Placebo | Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
|
| Before treatment and after 1, 2, 3 and 4 weeks of treatment |
| Vital Capacity (VC) | Change in VC from baseline to end of treatment | Before treatment and after 1, 2, 3 and 4 weeks of treatment |
| Inspiratory Capacity (IC) | Change from IC baseline to end of treatment | Before treatment and after 1, 2, 3 and 4 weeks of treatment |
| Forced Expiratory Flow (FEF) 25%-75% | Change in FEF from baseline to end of treatment | Before treatment and after 1, 2, 3 and 4 weeks of treatment |
| Peak Expiratory Flow (PEF) Morning | Change from average during run-in to average during treatment | Daily during run-in and treatment |
| Peak Expiratory Flow (PEF) Evening | Change in PEF from average during run-in to average during treatment | Daily during run-in and treatment |
| The Clinical COPD ( Chronic Obstructive Pulmonary Disease) 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, 3 and 4 weeks of treatment |
| Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Breathlessness | Change from average during run-in to average during treatment. Scores on a Scale, 5-point Likert-type scale, ranging from 0 (none) to 4 (severe). | Daily during run-in and treatment |
| Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Chest Tightness | Change from average during run-in to average during treatment. Scores on a Scale, 5-point Likert-type scale, ranging from 0 (none) to 4 (severe). | Daily during run-in and treatment |
| Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Cough Score | Change from average during run-in to average during treatment. Scores on a Scale, 5-point Likert-type scale, ranging from 0 (none) to 4 (severe). | Daily during run-in and treatment |
| Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Sleep Score | Change from average during run-in to average during treatmentScores on a Scale, 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 4 weeks of treatment |
| København NV |
| Denmark |
| Research Site | Odense C | Denmark |
| Research Site | Helsinki | Finland |
| Research Site | Preitilä | Finland |
| Research Site | Tampere | Finland |
| Research Site | Breda | Netherlands |
| Research Site | Groningen | Netherlands |
| Research Site | Elverum | Norway |
| Research Site | Oslo | Norway |
| Research Site | Trondheim | Norway |
| Research Site | Lund | Sweden |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | AZD4818 | AZD4818 Turbuhaler |
| BG001 | Placebo | Placebo |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 | Number of Patients Experiencing Adverse Events | Number of patients who had an Adverse Event | Posted | Number | Participants | At all study visits |
|
|
| ||||||||||||||||||||||||||||||
| Secondary | Forced Expiratory Volume 1 (FEV1) | Change in (FEV1) from baseline to end of treatment | Posted | Mean | Full Range | L | Before treatment and after 1, 2, 3 and 4 weeks of treatment |
|
| ||||||||||||||||||||||||||||||
| 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, 3 and 4 weeks of treatment |
|
| ||||||||||||||||||||||||||||||
| Secondary | Vital Capacity (VC) | Change in VC from baseline to end of treatment | Posted | Mean | Full Range | L | Before treatment and after 1, 2, 3 and 4 weeks of treatment |
|
| ||||||||||||||||||||||||||||||
| Secondary | Inspiratory Capacity (IC) | Change from IC baseline to end of treatment | Posted | Mean | Full Range | L | Before treatment and after 1, 2, 3 and 4 weeks of treatment |
|
| ||||||||||||||||||||||||||||||
| 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, 3 and 4 weeks of treatment |
|
| ||||||||||||||||||||||||||||||
| Secondary | Peak Expiratory Flow (PEF) Morning | Change from average during run-in to average during treatment | Posted | Mean | Full Range | L/min | Daily during run-in and treatment |
|
| ||||||||||||||||||||||||||||||
| Secondary | Peak Expiratory Flow (PEF) Evening | Change in PEF from average during run-in to average during treatment | Posted | Mean | Full Range | L/min | Daily during run-in and treatment |
|
| ||||||||||||||||||||||||||||||
| Secondary | The Clinical COPD ( Chronic Obstructive Pulmonary Disease) 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 a scale | Before treatment and after 1, 2, 3 and 4 weeks of treatment |
|
| ||||||||||||||||||||||||||||||
| Secondary | Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Breathlessness | Change from average during run-in to average during treatment. Scores on a Scale, 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 |
|
| ||||||||||||||||||||||||||||||
| Secondary | Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Chest Tightness | Change from average during run-in to average during treatment. Scores on a Scale, 5-point Likert-type scale, ranging from 0 (none) to 4 (severe). | Posted | Mean | Full Range | Score on a scale | Daily during run-in and treatment |
|
| ||||||||||||||||||||||||||||||
| Secondary | Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Cough Score | Change from average during run-in to average during treatment. Scores on a Scale, 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 |
|
| ||||||||||||||||||||||||||||||
| Secondary | Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Sleep Score | Change from average during run-in to average during treatmentScores on a Scale, 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 |
|
| ||||||||||||||||||||||||||||||
| Secondary | 6-minute Walk Test | Change from baseline to end of treatment | Posted | Mean | Full Range | meter | Before treatment and after 4 weeks of treatment |
|
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AZD4818 | AZD4818 Turbuhaler | 2 | 33 | 22 | 33 | ||
| EG001 | Placebo | Placebo | 0 | 32 | 22 | 32 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Deep Venous Thrombosis Left Lower Leg | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
| |
| COPD Exacerbation | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chronic obstructuve pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| nasopharyngitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
The PI agrees to collaborate with AZ in regard to the contents and formation of any publication or disclosure and to considerate the comments,views and opinions offered by AZ. Prior to any publication or disclosure the PI will provide AZ with preliminary data and drafts of proposed publication or disclosure and the proposed final manuscript. AZ will have a period of 30 days from receipt of the proposed final manuscript to review and may require submission for publication or disclosure be delayed
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gerard Lynch | AstraZeneca | aztrial_results_posting@astrazeneca.com |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D053120 | Respiratory Aspiration |
| 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 |
| D012120 | Respiration Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| C546512 | AZD-4818 |
Not provided
Not provided
Not provided
| Male |
|
|
|
|
|
|
|
|
|
|
|
|
|
|