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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT number: 2010-020506-15 |
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The purpose of this study is to investigate effects of inhaled AZD8683 compared to placebo in COPD patients.
A double-blind, placebo-controlled, randomised, multi-centre, 3-way cross-over, single-dose phase II study to investigate the local and systemic effects of inhaled AZD8683 in patients with chronic obstructive pulmonary disease (COPD)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| First 50 mcg, then 200 mcg, then placebo | Experimental | period 1: AZD8683 50 mcg, period 2: washout, period 3: AZD8683 200 mcg, period 4:washout, period5: placebo |
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| First 50 mcg, then placebo, then 200 mcg | Experimental | period 1: AZD8683 50 mcg, period 2: washout, period 3: placebo, period 4: washout, period5:AZD8683 200 mcg |
|
| First 200 mcg, then placebo, then 50 mcg | Experimental | period 1: AZD8683 200 mcg, period 2: washout, period 3: placebo, period 4: washout, period 5: AZD8683 50 mcg |
|
| First 200 mcg, then 50 mcg, then placebo | Experimental | period 1: AZD8683 200 mcg, period 2: washout, period 3: AZD8683 50 mcg, period 4: washout, period 5: placebo |
|
| First placebo, then 200 mcg, then 50 mcg | Experimental | period 1: placebo , period 2: washout, period 3: AZD8683 200 mcg, period 4: washout, period5: AZD8683 50 mcg |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD8683, 50 mcg | Drug | Dry powder for inhalation, single dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Forced Expiratory Volume in One Second (FEV1), Peak Effect Within 0 - 24 Hours Post-dose | Maximum FEV1 value | 0, 5 min, 15 min, 30 min, 1 h, 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, 14 h, 18 h, 22 h, 24 h |
| Forced Expiratory Volume in One Second (FEV1), Average Effect Over 22 - 26 Hours Post-dose | Trough FEV1 value | 22 h, 24 h, 26 h |
| Measure | Description | Time Frame |
|---|---|---|
| Forced Expiratory Volume in One Second (FEV1), Average Effect Over 0 - 24 Hours Post-dose | Average FEV1 value | 0, 5 min, 15 min, 30 min, 1 h, 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, 14 h, 18 h, 22 h, 24 h |
| Forced Vital Capacity (FVC), Peak Effect Over 0 - 24 Hours Post-dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Piotr Kuna, MD Professor | Poland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Bialystok | Poland | ||||
| Research Site |
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The study has been performed at four centers in Poland. The first subject entered the study on 10 October 2010 and the last subject completed the study on 17 December 2010. The randomised population consisted of 28 patients, 27 completed the study. All patients were included in the analysis of all variables.
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| ID | Title | Description |
|---|---|---|
| FG000 | First 50 mcg, Then 200 mcg, Then Placebo | period 1: AZD8683 50 mcg, period 2: washout, period 3: AZD8683 200 mcg, period 4: washout, period5: placebo |
| FG001 | First 50 mcg, Then Placebo, Then 200 mcg | period 1: AZD8683 50 mcg, period 2: washout, period 3: placebo, period 4: washout, period5:AZD8683 200 mcg |
| FG002 | First 200 mcg, Then Placebo, Then 50 mcg | period 1: AZD8683 200 mcg, period 2: washout, period 3: placebo, period 4: washout, period 5: AZD8683 50 mcg |
| FG003 | First 200 mcg, Then 50 mcg, Then Placebo | period 1: AZD8683 200 mcg, period 2: washout, period 3: AZD8683 50 mcg, period 4: washout, period 5: placebo |
| FG004 | First Placebo, Then 200 mcg, Then 50 mcg | period 1: placebo , period 2: washout, period 3: AZD8683 200 mcg, period 4: washout, period5: AZD8683 50 mcg |
| FG005 | First Placebo, Then 50 mcg, Then 200 mcg | period 1: placebo , period 2: washout, period 3: AZD8683 50 mcg, period 4: washout, period5: AZD8683 200 mcg |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 - First Intervention |
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| Period 2 - Washout |
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| Period 3 - Second Intervention |
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| Period 4 - Washout |
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| Period 5 - Third Intervention |
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| ID | Title | Description |
|---|---|---|
| BG000 | Entire Study Population | Includes all groups randomized to one of 6 sequences of drug or placebo. |
| 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 |
| 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 | Forced Expiratory Volume in One Second (FEV1), Peak Effect Within 0 - 24 Hours Post-dose | Maximum FEV1 value | Of the 28 randomised patients, 27 completed the study and one discontinued during the last washout period. All 28 randomised patients were included in the analyses of all variables | Posted | Mean | Standard Deviation | L | 0, 5 min, 15 min, 30 min, 1 h, 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, 14 h, 18 h, 22 h, 24 h |
|
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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 | AZD8683 50 mcg | 1 x AZD8683 Turbuhaler 50mcg + 3x placebo Turbuhaler (dry powder inhaler) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gerard Lynch | AstraZeneca | aztrial_results_posting@astrazeneca.com |
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| 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 |
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|
| First placebo, then 50 mcg, then 200 mcg | Experimental | period 1: placebo , period 2: washout, period 3: AZD8683 50 mcg, period 4: washout, period5: AZD8683 200 mcg |
|
| Placebo | Drug | Dry powder for inhalation, single dose |
|
| AZD8683, 200 mcg | Drug | Dry powder for inhalation, single dose |
|
Maximum FVC value |
| 0, 5 min, 15 min, 30 min, 1 h, 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, 14 h, 18 h, 22 h, 24 h |
| Systolic Blood Pressure, Average Effect Over 0 - 4 Hours Post-dose | Average systolic blood pressure value | 0, 30 min, 2 h, 4 h |
| Diastolic Blood Pressure, Average Effect Over 0 - 4 Hours Post-dose | Average diastolic blood pressure value | 0, 30 min, 2 h, 4 h |
| Pulse, Average Effect Over 0 - 4 Hours Post-dose | Average pulse value | 0, 30 min, 2 h, 4 h |
| Heart Rate, Average Effect Over 0 - 4 Hours Post-dose | Average heart rate value | 0, 30 min, 2 h, 4 h |
| QTcF, Average Effect Over 0 - 4 Hours Post-dose | Average QTcF value. QTcF = QT interval corrected for heart rate using Fridericia's formula | 0, 30 min, 2 h, 4 h |
| Plasma AZD8683 Cmax | Maximum plasma concentration of AZD8683 | 0, 5 min, 15 min, 30 min, 45 min, 1 h, 90 min, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h |
| Plasma AZD8683 AUC0-24 | Area under the AZD8683 plasma concentration curve from 0 to 24 hours | 0, 5 min, 15 min, 30 min, 45 min, 1 h, 90 min, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h |
| Bydgoszcz |
| Poland |
| Research Site | Lodz | Poland |
| Research Site | Proszowice | Poland |
| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
|
|
| COMPLETED |
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| NOT COMPLETED |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG002 | Placebo | 1 x Placebo Turbuhaler + 3 x Placebo Turbuhaler (dry powder inhaler) |
|
|
| Primary | Forced Expiratory Volume in One Second (FEV1), Average Effect Over 22 - 26 Hours Post-dose | Trough FEV1 value | Of the 28 randomised patients, 27 completed the study and one discontinued during the last washout period. All 28 randomised patients were included in the analyses of all variables | Posted | Mean | Standard Deviation | L | 22 h, 24 h, 26 h |
|
|
|
| Secondary | Forced Expiratory Volume in One Second (FEV1), Average Effect Over 0 - 24 Hours Post-dose | Average FEV1 value | Of the 28 randomised patients, 27 completed the study and one discontinued during the last washout period. All 28 randomised patients were included in the analyses of all variables | Posted | Mean | Standard Deviation | L | 0, 5 min, 15 min, 30 min, 1 h, 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, 14 h, 18 h, 22 h, 24 h |
|
|
|
| Secondary | Forced Vital Capacity (FVC), Peak Effect Over 0 - 24 Hours Post-dose | Maximum FVC value | Of the 28 randomised patients, 27 completed the study and one discontinued during the last washout period. All 28 randomised patients were included in the analyses of all variables | Posted | Mean | Standard Deviation | L | 0, 5 min, 15 min, 30 min, 1 h, 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, 14 h, 18 h, 22 h, 24 h |
|
|
|
| Secondary | Systolic Blood Pressure, Average Effect Over 0 - 4 Hours Post-dose | Average systolic blood pressure value | Of the 28 randomised patients, 27 completed the study and one discontinued during the last washout period. All 28 randomised patients were included in the analyses of all variables | Posted | Mean | Standard Deviation | mmHg | 0, 30 min, 2 h, 4 h |
|
|
|
| Secondary | Diastolic Blood Pressure, Average Effect Over 0 - 4 Hours Post-dose | Average diastolic blood pressure value | Of the 28 randomised patients, 27 completed the study and one discontinued during the last washout period. All 28 randomised patients were included in the analyses of all variables | Posted | Mean | Standard Deviation | mmHg | 0, 30 min, 2 h, 4 h |
|
|
|
| Secondary | Pulse, Average Effect Over 0 - 4 Hours Post-dose | Average pulse value | Of the 28 randomised patients, 27 completed the study and one discontinued during the last washout period. All 28 randomised patients were included in the analyses of all variables | Posted | Mean | Standard Deviation | bpm | 0, 30 min, 2 h, 4 h |
|
|
|
| Secondary | Heart Rate, Average Effect Over 0 - 4 Hours Post-dose | Average heart rate value | Of the 28 randomised patients, 27 completed the study and one discontinued during the last washout period. All 28 randomised patients were included in the analyses of all variables | Posted | Mean | Standard Deviation | bpm | 0, 30 min, 2 h, 4 h |
|
|
|
| Secondary | QTcF, Average Effect Over 0 - 4 Hours Post-dose | Average QTcF value. QTcF = QT interval corrected for heart rate using Fridericia's formula | Of the 28 randomised patients, 27 completed the study and one discontinued during the last washout period. All 28 randomised patients were included in the analyses of all variables | Posted | Mean | Standard Deviation | ms | 0, 30 min, 2 h, 4 h |
|
|
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| Secondary | Plasma AZD8683 Cmax | Maximum plasma concentration of AZD8683 | Plasma concentrations were below the LLOQ for all post-dose samples for some patients and treatments. PK parameters for these 3 treatments have been set to missing and are not included in the descriptive statistics. | Posted | Geometric Mean | Full Range | nmol/L | 0, 5 min, 15 min, 30 min, 45 min, 1 h, 90 min, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h |
|
|
|
| Secondary | Plasma AZD8683 AUC0-24 | Area under the AZD8683 plasma concentration curve from 0 to 24 hours | Plasma concentrations were below the LLOQ for all post-dose samples for some patients and treatments. PK parameters for these 3 treatments have been set to missing and are not included in the descriptive statistics. | Posted | Geometric Mean | Full Range | nmol*h/L | 0, 5 min, 15 min, 30 min, 45 min, 1 h, 90 min, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h |
|
|
|
| 0 |
| 28 |
| 0 |
| 28 |
| EG001 | AZD8683 200 mcg | 1 x AZD8683 Turbuhaler 50 mcg + 3 x AZD8683 Turbuhaler 50 mcg (dry powder inhaler) | 0 | 28 | 0 | 28 |
| EG002 | Placebo | 1 x Placebo Turbuhaler + 3 x Placebo Turbuhaler (dry powder inhaler) | 0 | 27 | 0 | 27 |
An Investigator agrees to provide a copy of the publication to AZ for review at least 60 days in advance of submission for publication. Investigators in multicenter (MC) studies agree to postpone MC publications until the earlier of the date of the first AZ-authorized MC publication or a period up to 18 months from study completion at all sites. AZ has the right to request delays: up to 60 days for confidential information, and an additional 90 days to protect intellectual property.
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012120 | Respiration Disorders |