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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-000133-37 | EudraCT Number |
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The purpose of this study is to evaluate the pharmacokinetics and pharmacodynamics of single doses of three different dry powder inhalation formulations of AZD3199 administered via Single Inhalation Device (SID) compared to AZD3199 administered via Turbuhaler™ Inhaler and compared to placebo in patients with persistent asthma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | AZD3199 800 µg inhaled via single inhaler device (SID), single dose |
|
| 2 | Experimental | AZD3199 880 µg inhaled via SID, single dose |
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| 3 | Experimental | AZD3199 1400 µg inhaled via SID, single dose |
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| 4 | Experimental | AZD3199 300 µg inhaled via Turbuhaler inhaler, single dose |
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| 5 | Experimental | AZD3199 1200 µg inhaled via Turbuhaler inhaler, single dose |
|
| 6 | Placebo Comparator | Placebo inhaled via Turbuhaler inhaler and SID, single dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD3199 | Drug | Inhaled via single inhaler device (SID) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Emax: Maximum Value of FEV1 for Every Treatment Visits | Peak effect (Emax) within 0-24 hours of FEV1, for treatment visits 2 to 7. | 0-24 hrs |
| E22-26h: The Average of the FEV1 Values Between 22 and 26 h for Every Treatment Visit | Trough effect (E22-26h) will be computed from the repeated measurements collected after each single dose during 22-26 hours of FEV1 from visit 2 to 7. | 22-26 hrs. |
| Measure | Description | Time Frame |
|---|---|---|
| tEmax: Time to Maximum Value of FEV1 for Every Treatment Visit | Time to peak effect (tEmax), within 0-24 hours of FEV1, for treatment visits 2 to 7. | 0 - 24 hrs. |
| E5min: The Value of FEV1 at 5 Min for Every Treatment Visit. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Gothenburg | Sweden | ||||
| Research Site |
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A total of 39 patients were enrolled at 3 centres in Sweden. Of these, 26 patients were randomised to receive a treatment sequence consisting of 6 different treatments in random order. The number of patients randomised was well balanced across all the treatment periods. In total, 25 patients completed the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | 1400 μg / Placebo / 880 μg / 1200 μg / 800 μg / 300 μg | AZD3199 1400 μg SID followed by Placebo followed by AZD3199 880 μg SID followed by AZD3199 1200 μg Turbuhaler inhaler followed by AZD3199 800 μg SID followed by AZD3199 300 μg Turbuhaler inhaler. |
| FG001 | 880 μg / 1400 μg / 800 μg / Placebo / 300 μg / 1200 μg | AZD3199 880 μg SID followed by AZD3199 1400 μg SID followed by AZD3199 800 μg SID followed by Placebo followed by AZD3199 300 μg Turbuhaler inhaler followed by AZD3199 1200 μg Turbuhaler inhaler. |
| FG002 | 800 μg / 880 μg / 300 μg / 1400 μg / 1200 μg / Placebo | AZD3199 800 μg SID followed by AZD3199 880 μg SID followed by AZD3199 300 μg Turbuhaler inhaler followed by AZD3199 1400 μg SID followed by AZD3199 1200 μg Turbuhaler inhaler followed by Placebo. |
| FG003 | 300 μg / 800 μg / 1200 μg / 880 μg / Placebo / 1400 μg | AZD3199 300 μg Turbuhaler inhaler followed by AZD3199 800 μg SID followed by AZD3199 1200 μg Turbuhaler inhaler followed by AZD3199 880 μg SID followed by Placebo followed by AZD3199 1400 μg SID. |
| FG004 | 1200 μg / 300 μg / Placebo / 800 μg / 1400 μg / 880 μg | AZD3199 1200 μg Turbuhaler inhaler followed by AZD3199 300 μg Turbuhaler inhaler followed by Placebo followed by AZD3199 800 μg SID followed by AZD3199 1400 μg SID followed by AZD3199 880 μg SID. |
| FG005 | Placebo / 1200 μg / 1400 μg / 300 μg / 880 μg / 800 μg | Placebo followed by AZD3199 1200 μg Turbuhaler inhaler followed by AZD3199 1400 μg SID followed by AZD3199 300 μg Turbuhaler inhaler followed by AZD3199 880 μg SID followed by AZD3199 800 μg SID. |
| 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 randomised 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 | Emax: Maximum Value of FEV1 for Every Treatment Visits | Peak effect (Emax) within 0-24 hours of FEV1, for treatment visits 2 to 7. | Posted | Mean | Standard Deviation | Liters | 0-24 hrs |
|
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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 1400 μg | AZD3199 1400 μg SID |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| VOMITING | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gerard Lynch | AstraZeneca | aztrial_results_posting@astrazeneca.com |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| 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 |
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| AZD3199 |
| Drug |
Inhaled via Turbuhaler inhaler |
|
| AZD3199 Placebo | Other | Inhaled via Turbuhaler inhaler and SID |
|
Onset of effect (E5min), observed at 5 min. FEV1 for treatment visits 2 to 7.
| FEV1 at 5 min |
| E0-24h: The Average of the FEV1 Values Between 0 and 24 h for Every Treatment Visit | Average effect over 0-24 hours of FEV1 (E0-24h), for treatment visits 2 to 7. | 0 - 24 hrs |
| Emax: Maximum Value of Pulse for Every Treatment Visits | Peak effect (Emax) within 0-4 hours of pulse, for treatment visits 2 to 7. | 0 - 4 hrs. |
| E0-4h: The Average of the Pulse Values Between 0 and 4 h for Every Treatment Visit | Average effect (E0-4h) of Pulse, for treatment visits 2 to 7. | 0 - 4 hrs. |
| Cmax: Maximum Plasma Concentration | Maximum plasma concentration (Cmax) for AZD3199 doses | 0 - 120 hrs for first two treatment visit 2 and 3 and 0 - 48 hrs for other treatment visits. |
| AUC: Area Under the Plasma Concentration-time Curve From Zero to Infinity (AUC), | Area under the plasma concentration-time curve from zero to infinity (AUC), for AZD3199 doses | 0 - 120 hrs for first two treatment visit 2 and 3 and 0 - 48 hrs for other treatment visits. |
| Tmax:Time to Maximum Plasma Concentration | Time to maximum plasma concentration (tmax), for AZD3199 doses | 0 - 120 hrs for first two treatment visit 2 and 3 and 0 - 48 hrs for other treatment visits. |
| t1/2 :Terminal Half-life | Terminal half-life (t1/2),for AZD3199 doses | 0 - 120 hrs for first two treatment visit 2 and 3 and 0 - 48 hrs for other treatment visits. |
| Luleå |
| Sweden |
| Research Site | Lund | Sweden |
| 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 |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | Participants |
|
| OG003 |
| Arm 4 - AZD3199 300 μg |
AZD3199 300 μg Turbuhaler inhaler |
| OG004 | Arm 5 - AZD3199 1200 μg | AZD3199 1200 μg Turbuhaler inhaler |
| OG005 | Arm 6 - Placebo | Placebo |
|
|
| Primary | E22-26h: The Average of the FEV1 Values Between 22 and 26 h for Every Treatment Visit | Trough effect (E22-26h) will be computed from the repeated measurements collected after each single dose during 22-26 hours of FEV1 from visit 2 to 7. | PD analysis set | Posted | Mean | Standard Deviation | Liters | 22-26 hrs. |
|
|
|
| Secondary | tEmax: Time to Maximum Value of FEV1 for Every Treatment Visit | Time to peak effect (tEmax), within 0-24 hours of FEV1, for treatment visits 2 to 7. | PD analysis set | Posted | Median | Full Range | Hours | 0 - 24 hrs. |
|
|
|
| Secondary | E5min: The Value of FEV1 at 5 Min for Every Treatment Visit. | Onset of effect (E5min), observed at 5 min. FEV1 for treatment visits 2 to 7. | PD analysis set | Posted | Mean | Standard Deviation | Liters | FEV1 at 5 min |
|
|
|
| Secondary | E0-24h: The Average of the FEV1 Values Between 0 and 24 h for Every Treatment Visit | Average effect over 0-24 hours of FEV1 (E0-24h), for treatment visits 2 to 7. | PD analysis set | Posted | Mean | Standard Deviation | Liters | 0 - 24 hrs |
|
|
|
| Secondary | Emax: Maximum Value of Pulse for Every Treatment Visits | Peak effect (Emax) within 0-4 hours of pulse, for treatment visits 2 to 7. | PD analysis set | Posted | Mean | Standard Deviation | Beats/min | 0 - 4 hrs. |
|
|
|
| Secondary | E0-4h: The Average of the Pulse Values Between 0 and 4 h for Every Treatment Visit | Average effect (E0-4h) of Pulse, for treatment visits 2 to 7. | PD analysis set | Posted | Mean | Standard Deviation | Beats/min | 0 - 4 hrs. |
|
|
|
| Secondary | Cmax: Maximum Plasma Concentration | Maximum plasma concentration (Cmax) for AZD3199 doses | PK analysis set | Posted | Mean | Standard Deviation | nmol/L | 0 - 120 hrs for first two treatment visit 2 and 3 and 0 - 48 hrs for other treatment visits. |
|
|
|
| Secondary | AUC: Area Under the Plasma Concentration-time Curve From Zero to Infinity (AUC), | Area under the plasma concentration-time curve from zero to infinity (AUC), for AZD3199 doses | PK analysis set | Posted | Mean | Standard Deviation | nmol*h/L | 0 - 120 hrs for first two treatment visit 2 and 3 and 0 - 48 hrs for other treatment visits. |
|
|
|
| Secondary | Tmax:Time to Maximum Plasma Concentration | Time to maximum plasma concentration (tmax), for AZD3199 doses | PK analysis set | Posted | Median | Full Range | Hours | 0 - 120 hrs for first two treatment visit 2 and 3 and 0 - 48 hrs for other treatment visits. |
|
|
|
| Secondary | t1/2 :Terminal Half-life | Terminal half-life (t1/2),for AZD3199 doses | PK analysis set | Posted | Mean | Standard Deviation | Hours | 0 - 120 hrs for first two treatment visit 2 and 3 and 0 - 48 hrs for other treatment visits. |
|
|
|
| 0 |
| 26 |
| 9 |
| 26 |
| EG001 | AZD3199 880 μg | AZD3199 880 μg SID | 0 | 25 | 9 | 25 |
| EG002 | AZD3199 800 μg | AZD3199 800 μg SID | 0 | 25 | 7 | 25 |
| EG003 | AZD3199 300 μg | AZD3199 300 μg Turbuhaler inhaler | 0 | 25 | 7 | 25 |
| EG004 | AZD3199 1200 μg | AZD3199 1200 μg Turbuhaler inhaler | 0 | 25 | 14 | 25 |
| EG005 | Placebo | Placebo | 0 | 25 | 6 | 25 |
| NASOPHARYNGITIS | Infections and infestations | Systematic Assessment |
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| DYSGEUSIA | Nervous system disorders | Systematic Assessment |
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| HEADACHE | Nervous system disorders | Systematic Assessment |
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| COUGH | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| THROAT IRRITATION | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
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| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |