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| ID | Type | Description | Link |
|---|---|---|---|
| ToBe |
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The purpose of this study is to investigate the pharmacodynamics of single doses of AZD3199 in asthmatic patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| crossover dose 1 | Experimental | AZD3199 120 microgram |
|
| crossover dose 2 | Experimental | AZD3199 480 microgram |
|
| crossover dose 3 | Experimental | AZD3199 1920 microgram |
|
| crossover dose 4 | Placebo Comparator | Placebo |
|
| crossover dose 5 | Active Comparator | Formoterol 9 microgram |
|
| crossover dose 6 | Active Comparator | Formoterol 36 microgram |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD3199 | Drug | Dry powder for inhalation, single dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| FEV1 Peak Effect Within 0 - 24 h Post-dose | Maximum FEV1 value | 0, 5min, 15min, 30min, 1h, 2h, 4h, 6h, 8h, 10h, 12h, 14h, 18h, 22h, 24h |
| E22-26: the Average of the FEV1 Value Between 22 and 26 h Post Dose for Every Treatment Visit. | Residual FEV1 24 h post-dose | 22- 26 h post dose |
| S-potassium, Peak Effect Over 0 - 4 h Post-dose | Minimum S-potassium concentration (A well-known effect of beta2-agonists (AZD3199 is a beta2-agonist) is a reduction in serum potassium levels. The minimum value has therefore been evaluated. | 0, 15min, 30min,1h, 2h, 4h |
| S-potassium, Average Effect Over 0 - 4 h Post-dose | Average S-potassium concentration | 0, 15min, 30min,1h, 2h, 4h |
| Measure | Description | Time Frame |
|---|---|---|
| FEV1 Effect at 5 Min Post-dose | FEV1 at 5 minutes | 5min |
| FEV1 Average Effect Over 0 - 24 h Post-dose | FEV1 average effect over 24 h dosing interval |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Prof Leif Bjermer, MD, PhD | University Hospital in Lund, Sweden | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Hvidovre | Denmark | ||||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23907810 | Derived | Bjermer L, Rosenborg J, Bengtsson T, Lotvall J. Comparison of the bronchodilator and systemic effects of AZD3199, an inhaled ultra-long-acting beta(2)-adrenoceptor agonist, with formoterol in patients with asthma. Ther Adv Respir Dis. 2013 Oct;7(5):264-71. doi: 10.1177/1753465813497527. Epub 2013 Aug 1. |
| Label | URL |
|---|---|
| Related Info | View source |
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The study has been performed in Sweden and Denmark at two University hospital clinics and two CROs. The recruitment period was between 11 August 2008 to 22 October 2008.
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| ID | Title | Description |
|---|---|---|
| FG000 | APCDEBa | AZD3199 120 Mcg followed by Placebo followed by AZD3199 1920 Mcg followed by Formoterol 9 Mcg followed by Formoterol 36 Mcg followed by AZD3199 480 Mcg. |
| FG001 | BADEPCa | AZD3199 480 Mcg followed by AZD3199 120 Mcg followed by Formoterol 9 Mcg followed by Formoterol 36 Mcg followed by Placebo followed by AZD3199 1920 Mcg. |
| FG002 | CBEPADa | AZD3199 1920 Mcg followed by AZD3199 480 Mcg followed by Formoterol 36 Mcg followed by Placebo followed by AZD3199 120 Mcg followed by Formoterol 9 Mcg . |
| FG003 | DCPABEa | Formoterol 9 Mcg followed by AZD3199 1920 Mcg followed by Placebo followed by AZD3199 120 Mcg followed by AZD3199 480 Mcg followed by Formoterol 36 Mcg. |
| FG004 | EDABCPa | Formoterol 36 Mcg followed by Formoterol 9 Mcg followed by AZD3199 120 Mcg followed by AZD3199 480 Mcg followed by AZD3199 1920 Mcg followed by Placebo. |
| FG005 | PEBCDAa | Placebo followed by Formoterol 36 Mcg followed by AZD3199 480 Mcg followed by AZD3199 1920 Mcg followed by Formoterol 9 Mcg followed by AZD3199 120 Mcg. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
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| Period 2 |
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| Period 3 |
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| Period 4 |
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| Period 5 |
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| Period 6 |
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| ID | Title | Description |
|---|---|---|
| BG000 | Baseline Total | Total number of patients randomized and treated in the study |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | FEV1 Peak Effect Within 0 - 24 h Post-dose | Maximum FEV1 value | Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences. One patient on Placebo treatment had data not sufficient for computing PD parameters and for subsequent analysis. | Posted | Mean | Standard Deviation | L | 0, 5min, 15min, 30min, 1h, 2h, 4h, 6h, 8h, 10h, 12h, 14h, 18h, 22h, 24h |
|
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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 | AZD3199 120 mcg | AZD3199 120 Mcg inhaled via Turbuhaler |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA 10.0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Carin Jorup, MSD | AstraZeneca | ClinicalTrialTransparency@astrazeneca.com |
| ID | Term |
|---|---|
| D001249 | Asthma |
| D000402 | Airway Obstruction |
| D053120 | Respiratory Aspiration |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| C544523 | AZD-3199 |
| D000068759 | Formoterol Fumarate |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| Formoterol | Drug | Dry powder for inhalation, single dose |
|
|
| Placebo | Drug | Dry powder for inhalation, single dose |
|
| 0, 5min, 15min, 30min, 1h, 2h, 4h, 6h, 8h, 10h, 12h, 14h, 18h, 22h, 24h |
| FEV1 Average Effect Over 0 - 12 h Post-dose | FEV1 average effect over 12 h day-time period | 0, 5min, 15min, 30min, 1h, 2h, 4h, 6h, 8h, 10h, 12h |
| FEV1 Average Effect Over 12 - 24 h Post-dose | FEV1 average effect over 12 h night-time period | 12h, 14h, 18h, 22h, 24h |
| Systolic Blood Pressure, Peak Effect Over 0 - 4 h Post-dose | Maximum SBP value over 4 h | 0, 30min, 2h, 4h |
| Systolic Blood Pressure, Average Effect Over 0 - 4 h Post-dose | Average SBP value over 4 h | 0, 30min, 2h, 4h |
| Diastolic Blood Pressure, Peak Effect Over 0 - 4 h Post-dose | Minimum DBP value over 4 h | 0, 30min, 2h, 4h |
| Diastolic Blood Pressure, Average Effect Over 0 - 4 h Post-dose | Average DBP value over 4 h | 0, 30min, 2h, 4h |
| Pulse, Peak Effect Over 0 - 4 h Post-dose | Maximum pulse over 4 h | 0, 30min, 2h, 4h |
| Pulse, Average Effect Over 0 - 4 h Post-dose | Average pulse over 4 h | 0, 30min, 2h, 4h |
| Heart Rate, Peak Effect Over 0 - 4 h Post-dose | Maximum heart rate over 4 h | 0, 30min, 2h, 4h |
| Heart Rate, Average Effect Over 0 - 4 h Post-dose | Average heart rate over 4 h | 0, 30min, 2h, 4h |
| QTcB, Peak Effect Over 0 - 4 h Post-dose | Maximum QTc Bazett over 4 h | 0, 30min, 2h, 4h |
| QTcB, Average Effect Over 0 - 4 h Post-dose | Average QTc Bazett over 4 h | 0, 30min, 2h, 4h |
| Tremor, Peak Effect Over 0 - 4 h Post-dose | Maximum tremor score (4 grade scale: 0=no, 1=mild, 2=moderate or 3=severe) over 4 h. | 0, 15min, 30min, 1h, 2h, 4h |
| Tremor, Average Effect Over 0 - 4 h Post-dose | Average tremor score (4 grade scale: 0=no, 1=mild, 2=moderate or 3=severe) over 4 h. | 0, 15min, 30min, 1h, 2h, 4h |
| Palpitations, Peak Effect Over 0 - 4 h Post-dose | Maximum palpitation score (4 grade scale: 0=no, 1=mild, 2=moderate or 3=severe) over 4 h | 0, 15min, 30min, 1h, 2h, 4h |
| Palpitations, Average Effect Over 0 - 4 h Post-dose | Average palpitation score (4 grade scale: 0=no, 1=mild, 2=moderate or 3=severe) over 4 h | 0, 15min, 30min, 1h, 2h, 4h |
| Plasma AZD3199 Cmax | Maximum plasma concentration of AZD3199 measured | 0, 5min, 15min, 30min, 1h, 2h, 4h, 8h, 12h, 24h |
| Plasma AZD3199 AUC0-24 | Area under the plasma concentration curve from time 0 to 24 h post-dose | 0, 5min, 15min, 30min, 1h, 2h, 4h, 8h, 12h, 24h |
| Gothenburg |
| Sweden |
| Research Site | Luleå | Sweden |
| Research Site | Lund | Sweden |
| D0570C00007 CSR Synopsis | View source |
| Withdrawal by Subject |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
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| NOT COMPLETED |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG002 | AZD3199 1920 mcg | AZD3199 1920 Mcg inhaled via Turbuhaler |
| OG003 | Formoterol 9 mcg | Formoterol 9 Mcg inhaled via Turbuhaler |
| OG004 | Formoterol 36 mcg | Formoterol 36 Mcg inhaled via Turbuhaler |
| OG005 | Placebo | Placebo inhaled via Turbuhaler |
|
|
| Primary | E22-26: the Average of the FEV1 Value Between 22 and 26 h Post Dose for Every Treatment Visit. | Residual FEV1 24 h post-dose | Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences. One patient on Placebo treatment had data not sufficient for computing PD parameters and for subsequent analysis. | Posted | Mean | Standard Deviation | L | 22- 26 h post dose |
|
|
|
| Primary | S-potassium, Peak Effect Over 0 - 4 h Post-dose | Minimum S-potassium concentration (A well-known effect of beta2-agonists (AZD3199 is a beta2-agonist) is a reduction in serum potassium levels. The minimum value has therefore been evaluated. | Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences. Two patients on AZD3199 1920 mcg had data not sufficient for computing PD parameters and for subsequent analysis. | Posted | Mean | Standard Deviation | mmol/L | 0, 15min, 30min,1h, 2h, 4h |
|
|
|
| Primary | S-potassium, Average Effect Over 0 - 4 h Post-dose | Average S-potassium concentration | Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences. Two patients on AZD3199 1920 mcg had data not sufficient for computing PD parameters and for subsequent analysis. | Posted | Mean | Standard Deviation | mmol/L | 0, 15min, 30min,1h, 2h, 4h |
|
|
|
| Secondary | FEV1 Effect at 5 Min Post-dose | FEV1 at 5 minutes | Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences. Two patients on Placebo and 1 on AZD3199 480 mcg had data not sufficient for computing PD parameters and for subsequent analysis. | Posted | Mean | Standard Deviation | L | 5min |
|
|
|
| Secondary | FEV1 Average Effect Over 0 - 24 h Post-dose | FEV1 average effect over 24 h dosing interval | Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences. One patient on Placebo treatment had data not sufficient for computing PD parameters and for subsequent analysis. | Posted | Mean | Standard Deviation | L | 0, 5min, 15min, 30min, 1h, 2h, 4h, 6h, 8h, 10h, 12h, 14h, 18h, 22h, 24h |
|
|
|
| Secondary | FEV1 Average Effect Over 0 - 12 h Post-dose | FEV1 average effect over 12 h day-time period | Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences. One patient on Placebo treatment had data not sufficient for computing PD parameters and for subsequent analysis. | Posted | Mean | Standard Deviation | L | 0, 5min, 15min, 30min, 1h, 2h, 4h, 6h, 8h, 10h, 12h |
|
|
|
| Secondary | FEV1 Average Effect Over 12 - 24 h Post-dose | FEV1 average effect over 12 h night-time period | Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences. One patient on Placebo treatment had data not sufficient for computing PD parameters and for subsequent analysis. | Posted | Mean | Standard Deviation | L | 12h, 14h, 18h, 22h, 24h |
|
|
|
| Secondary | Systolic Blood Pressure, Peak Effect Over 0 - 4 h Post-dose | Maximum SBP value over 4 h | Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences. | Posted | Mean | Standard Deviation | mmHg | 0, 30min, 2h, 4h |
|
|
|
| Secondary | Systolic Blood Pressure, Average Effect Over 0 - 4 h Post-dose | Average SBP value over 4 h | Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences. | Posted | Mean | Standard Deviation | mmHg | 0, 30min, 2h, 4h |
|
|
|
| Secondary | Diastolic Blood Pressure, Peak Effect Over 0 - 4 h Post-dose | Minimum DBP value over 4 h | Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences. | Posted | Mean | Standard Deviation | mmHg | 0, 30min, 2h, 4h |
|
|
|
| Secondary | Diastolic Blood Pressure, Average Effect Over 0 - 4 h Post-dose | Average DBP value over 4 h | Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences. | Posted | Mean | Standard Deviation | mmHg | 0, 30min, 2h, 4h |
|
|
|
| Secondary | Pulse, Peak Effect Over 0 - 4 h Post-dose | Maximum pulse over 4 h | Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences. | Posted | Mean | Standard Deviation | bpm | 0, 30min, 2h, 4h |
|
|
|
| Secondary | Pulse, Average Effect Over 0 - 4 h Post-dose | Average pulse over 4 h | Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences. | Posted | Mean | Standard Deviation | bpm | 0, 30min, 2h, 4h |
|
|
|
| Secondary | Heart Rate, Peak Effect Over 0 - 4 h Post-dose | Maximum heart rate over 4 h | Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences. | Posted | Mean | Standard Deviation | bpm | 0, 30min, 2h, 4h |
|
|
|
| Secondary | Heart Rate, Average Effect Over 0 - 4 h Post-dose | Average heart rate over 4 h | Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences. | Posted | Mean | Standard Deviation | bpm | 0, 30min, 2h, 4h |
|
|
|
| Secondary | QTcB, Peak Effect Over 0 - 4 h Post-dose | Maximum QTc Bazett over 4 h | Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences. | Posted | Mean | Standard Deviation | ms | 0, 30min, 2h, 4h |
|
|
|
| Secondary | QTcB, Average Effect Over 0 - 4 h Post-dose | Average QTc Bazett over 4 h | Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences. | Posted | Mean | Standard Deviation | ms | 0, 30min, 2h, 4h |
|
|
|
| Secondary | Tremor, Peak Effect Over 0 - 4 h Post-dose | Maximum tremor score (4 grade scale: 0=no, 1=mild, 2=moderate or 3=severe) over 4 h. | Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences. One patient on Placebo, 1 patient on formoterol 36 mcg and 1 patient on AZD3199 480 mcg had no data for subsequent analysis. | Posted | Mean | Standard Deviation | Score on a scale | 0, 15min, 30min, 1h, 2h, 4h |
|
|
|
| Secondary | Tremor, Average Effect Over 0 - 4 h Post-dose | Average tremor score (4 grade scale: 0=no, 1=mild, 2=moderate or 3=severe) over 4 h. | Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences. One patient on Placebo, 1 patient on formoterol 36 mcg and 1 patient on AZD3199 480 mcg had no data for subsequent analysis. | Posted | Mean | Standard Deviation | Score on a scale | 0, 15min, 30min, 1h, 2h, 4h |
|
|
|
| Secondary | Palpitations, Peak Effect Over 0 - 4 h Post-dose | Maximum palpitation score (4 grade scale: 0=no, 1=mild, 2=moderate or 3=severe) over 4 h | Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences. One patient on Placebo, 1 patient on formoterol 36 mcg and 1 patient on AZD3199 480 mcg had no data for subsequent analysis. | Posted | Mean | Standard Deviation | Score on a scale | 0, 15min, 30min, 1h, 2h, 4h |
|
|
|
| Secondary | Palpitations, Average Effect Over 0 - 4 h Post-dose | Average palpitation score (4 grade scale: 0=no, 1=mild, 2=moderate or 3=severe) over 4 h | Two patients discontinued after the first treatment period and were excluded from pharmacodynamic analysis set since these patients are non-informative regarding treatment differences. One patient on Placebo, 1 patient on formoterol 36 mcg and 1 patient on AZD3199 480 mcg had no data for subsequent analysis. | Posted | Mean | Standard Deviation | Score on a scale | 0, 15min, 30min, 1h, 2h, 4h |
|
|
|
| Secondary | Plasma AZD3199 Cmax | Maximum plasma concentration of AZD3199 measured | Two patients discontinued after the first treatment period and were excluded from pharmacokinetic analysis set. | Posted | Geometric Mean | Full Range | nmol/L | 0, 5min, 15min, 30min, 1h, 2h, 4h, 8h, 12h, 24h |
|
|
|
| Secondary | Plasma AZD3199 AUC0-24 | Area under the plasma concentration curve from time 0 to 24 h post-dose | Two patients discontinued after the first treatment period and were excluded from pharmacokinetic analysis set. | Posted | Geometric Mean | Full Range | nmol*h/L | 0, 5min, 15min, 30min, 1h, 2h, 4h, 8h, 12h, 24h |
|
|
|
| 0 |
| 36 |
| 4 |
| 36 |
| EG001 | AZD3199 480 mcg | AZD3199 480 Mcg inhaled via Turbuhaler | 0 | 35 | 3 | 35 |
| EG002 | AZD3199 1920 mcg | AZD3199 1920 Mcg inhaled via Turbuhaler | 0 | 35 | 10 | 35 |
| EG003 | Formoterol 9 mcg | Formoterol 9 Mcg inhaled via Turbuhaler | 0 | 35 | 2 | 35 |
| EG004 | Formoterol 36 mcg | Formoterol 36 Mcg inhaled via Turbuhaler | 0 | 35 | 4 | 35 |
| EG005 | Placebo | Placebo inhaled via Turbuhaler | 0 | 36 | 6 | 36 |
| Nasopharyngitis | Infections and infestations | MedDRA 10.0 |
|
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 |
|
Prior to any publication or disclosure, the PI provides AstraZeneca with preliminary data and drafts and with the proposed final manuscript. AstraZeneca shall have a period of 30 days from receipt of the proposed final manuscript to review it and may within such time frame require that submission for publication or disclosure be delayed.
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D012131 | Respiratory Insufficiency |
| D012120 | Respiration Disorders |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000588 |
| Amines |