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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT number: 2012-002900-42 |
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This study in Chronic Obstructive Pulmonary Disease (COPD) patients will investigate the bronchodilatory effect of AZD8683. AZD8683 will be tested versus placebo and an active comparator.
A randomised, double-blind placebo- and active-controlled, multi-centre, 6-way cross-over, single-dose phase IIa study to investigate the bronchodilatory and systemic effects of 4 different doses of inhaled AZD8683 in patients with Chronic Obstructive Pulmonary Disease (COPD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Single dose of AZD8683 50 µg |
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| 2 | Experimental | Single dose of AZD8683 150 µg |
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| 3 | Experimental | Single dose of AZD8683 300 µg |
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| 4 | Experimental | Single dose of AZD8683 900 µg |
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| 5 | Placebo Comparator | Single dose of placebo |
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| 6 | Active Comparator | Single dose of tiotropium 18 µg |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD8683 | Drug | AZD8683 administered via inhalation |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Peak FEV1 (0-24h) | The maximum value over 24 hours post-dose, as change from baseline | The first 24 hours following dose administration |
| Change From Baseline in Trough FEV1 (22-26h) | The average over 22 to 26 hours, as change from baseline | 22 to 26 hours following dose administration |
| Measure | Description | Time Frame |
|---|---|---|
| Average FEV1 as a Change From Baseline | Average FEV1 (0-24h): The average over 0 to 24 hours | The first 24 hours following dose administration |
| Maximum Increase in Systolic Blood Pressure [SBP] |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carin Jorup, MD | AstraZeneca R&DMolndal, Sweden | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bialystok | Poland | |||||
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A total of 14 subjects were enrolled. Of these, 3 subjects were randomized to receive a treatment sequence consisting of 6 different treatments in random order. The study was terminated prematurely, hence only one period out of six planned was performed.
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| ID | Title | Description |
|---|---|---|
| FG000 | AFBECD | AZD8683 50 ug followed by Placebo followed by AZD8683 150 ug followed by Spiriva® 18 ug followed by AZD8683 300 ug followed by AZD8683 900 ug |
| FG001 | FEADBC | Placebo followed by Spiriva® 18 ug followed by AZD8683 50 ug followed by AZD8683 900 ug followed by AZD8683 150 ug followed by AZD8683 300 ug |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Placebo |
| Drug |
Placebo administered via inhalation |
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| Tiotropium | Drug | Tiotropium administered via inhalation |
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Maximum (post-dose values - baseline value) for each treatment visit.
| baseline, 24hr post dose |
| Maximum Increase in Diastolic Blood Pressure [DBP] | Maximum (post-dose values - baseline value) for each treatment visit. | The first 24 hours following dose administration |
| Maximum Increase Heart Rate [HR] | Maximum (post-dose values - baseline value) for each treatment visit. | baseline, 24hr post dose |
| Maximum Increase in QTcF | maximum (post-dose values - baseline value) for each treatment visit. | baseline, 24hr post dose |
| PK Parameters (AZD8683) | Cmax, tmax, AUC | Pre-dose, 24hr post-dose |
| Lodz |
| Poland |
| Proszowice | Poland |
| Wroclaw | Poland |
| Gothenburg | Sweden |
| Lund | Sweden |
| FG002 | DCEBFA | AZD8683 900 ug followed by AZD8683 300 ug followed by Spiriva® 18 ug followed by AZD8683 150 ug followed by Placebo followed by AZD8683 50 ug |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Total Baseline | All Patients population |
| 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, Customized | Number | participants |
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| Sex/Gender, Customized | Number | participants |
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| Race/Ethnicity, Customized | Number | 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 | Change From Baseline in Peak FEV1 (0-24h) | The maximum value over 24 hours post-dose, as change from baseline | As the study was terminated prematurely none of the randomised patients have been analysed. | Posted | The first 24 hours following dose administration |
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| Primary | Change From Baseline in Trough FEV1 (22-26h) | The average over 22 to 26 hours, as change from baseline | As the study was terminated prematurely none of the randomized patients have been analysed. | Posted | 22 to 26 hours following dose administration |
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| Secondary | Average FEV1 as a Change From Baseline | Average FEV1 (0-24h): The average over 0 to 24 hours | As the study was terminated prematurely none of the randomized patients have been analysed. | Posted | The first 24 hours following dose administration |
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| Secondary | Maximum Increase in Systolic Blood Pressure [SBP] | Maximum (post-dose values - baseline value) for each treatment visit. | As the study was terminated prematurely none of the randomised patients have bean analysed. | Posted | baseline, 24hr post dose |
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| Secondary | Maximum Increase in Diastolic Blood Pressure [DBP] | Maximum (post-dose values - baseline value) for each treatment visit. | As the study was terminated prematurely none of the randomised patients have bean analysed. | Posted | The first 24 hours following dose administration |
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| Secondary | Maximum Increase Heart Rate [HR] | Maximum (post-dose values - baseline value) for each treatment visit. | As the study was terminated prematurely none of the randomised patients have bean analysed. | Posted | baseline, 24hr post dose |
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| Secondary | Maximum Increase in QTcF | maximum (post-dose values - baseline value) for each treatment visit. | As the study was terminated prematurely none of the randomised patients have bean analysed. | Posted | baseline, 24hr post dose |
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| Secondary | PK Parameters (AZD8683) | Cmax, tmax, AUC | As the study was terminated prematurely none of the randomised patients have bean analysed. | Posted | Pre-dose, 24hr post-dose |
|
21 days
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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 | 50ug AZD8683 | AZD8683 50 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva | 0 | 1 | 0 | 1 | ||
| EG001 | 150 ug AZD8683 | AZD8683 150 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva | 0 | 0 | 0 | 0 | ||
| EG002 | 300 ug AZD8683 | AZD8683 300 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva | 0 | 0 | 0 | 0 | ||
| EG003 | 900 ug AZD8683 | AZD8683 900 ug via Turbuhaler + placebo for Spiriva via HandiHaler; | 0 | 1 | 1 | 1 | ||
| EG004 | 18ug Spiriva | Turbuhaler® Placebo+Handihaler® Spiriva® 18 μg | 0 | 0 | 0 | 0 | ||
| EG005 | Placebo | Turbuhaler® Placebo+Handihaler® Placebo for Spiriva® | 0 | 1 | 0 | 1 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA version 15.1 | Systematic Assessment |
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| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA version 15.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Carin Jorup | 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 |
|---|---|
| D000069447 | Tiotropium Bromide |
| ID | Term |
|---|---|
| D012602 | Scopolamine Derivatives |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
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| Title | Measurements |
|---|---|
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| OG005 | AZD8683 50ug | AZD8683 50 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva |
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| OG005 | AZD8683 50ug | AZD8683 50 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva |
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| OG005 | AZD8683 50ug | AZD8683 50 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva |
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| OG005 | AZD8683 50ug | AZD8683 50 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva |
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| OG005 | AZD8683 50ug | AZD8683 50 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva |
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| OG005 | AZD8683 50ug | AZD8683 50 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva |
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| OG005 |
| AZD8683 50ug |
AZD8683 50 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva |
|