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| Name | Class |
|---|---|
| MAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan | INDUSTRY |
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This Phase 2 study was to investigate the tolerability of unit dose budesonide (MAP0020) at three doses in pediatric volunteers with a diagnosis and history of mild-to-moderate stable asthma and evaluate the pharmacokinetic profile of budesonide resulting from inhalation aerosol delivery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A, then Treatment B, then Treatment C | Experimental | Study visits were separated by 3-7 day intervals. Treatment A: 84ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 2; Treatment B: 42ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 3; Treatment C: 21ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 4 |
|
| Treatment A, then Treatment C, then Treatment B | Experimental | Study visits were separated by 3-7 day intervals. Treatment A: 84ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 2; Treatment C: 21ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 3; Treatment B: 42ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 4 |
|
| Treatment B, then Treatment A, then Treatment C | Experimental | Study visits were separated by 3-7 day intervals. Treatment B: 42ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 2; Treatment A: 84ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 3; Treatment C: 21ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 4 |
|
| Treatment B, then Treatment C, then Treatment A | Experimental | Study visits were separated by 3-7 day intervals. Treatment B: 42ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 2; Treatment C: 21ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 3; Treatment A: 84ug of unit dose budesonide delivered by Aeroneb® Go (MAP0020) at Visit 4 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 84ug MAP0020 | Drug | 84ug of unit dose budesonide inhalation suspension delivered by Aeroneb® Go (MAP0020) as per protocol |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax of Budesonide After Administration of MAP0020 | The maximum concentration (Cmax) is the highest concentration of a drug measured in the plasma. Plasma is the clear portion of the blood. The Cmax of Budesonide is reported in picograms per milliliter (pg/ml). | 12 hours |
| AUC(0-inf) of Budesonide After Administration of MAP0020 | The AUC(0-inf) is the area under the plot of plasma concentration of drug to time infinity after drug administration. Budesonide AUC(0-inf) is reported in picograms times minutes per milliliter (pg*min/ml). | 12 hours |
| Half-life (t1/2) of Budesonide After Administration of MAP0020 | Half-life (t1/2) is the time for the drug to decrease to half of its maximum concentration. Budesonide t1/2 is reported in minutes. | 12 hours |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul Ratner, MD | Sylvana Research Associates | Principal Investigator |
| Ammar Hatab, MD | West Coast Clinical Trials LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West Coast Clinical Trials LLC | Cypress | California | United States | |||
| Sylvana Research Associates |
This is a 3-treatment, 3-period, 6-sequence crossover study. Each subject received all 3 treatments in a randomly assigned order: treatments A, B, and C, the sequences were ABC, ACB, BAC, BCA, CAB, and CBA.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment A, Then Treatment B, Then Treatment C | Study visits were separated by 3-7 day intervals. Treatment A: 84ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 2; Treatment B: 42ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 3; Treatment C: 21ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 4 |
| FG001 | Treatment A, Then Treatment C, Then Treatment B | Study visits were separated by 3-7 day intervals. Treatment A: 84ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 2; Treatment C: 21ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 3; Treatment B: 42ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 4 |
| FG002 | Treatment B, Then Treatment A, Then Treatment C | Study visits were separated by 3-7 day intervals. Treatment B: 42ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 2; Treatment A: 84ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 3; Treatment C: 21ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 4 |
| FG003 | Treatment B, Then Treatment C, Then Treatment A | Study visits were separated by 3-7 day intervals. Treatment B: 42ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 2; Treatment C: 21ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 3; Treatment A: 84ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 4 |
| FG004 | Treatment C, Then Treatment A, Then Treatment B | Study visits were separated by 3-7 day intervals. Treatment C: 21ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 2; Treatment A: 84ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 3; Treatment B: 42ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 4 |
| FG005 | Treatment C, Then Treatment B, Then Treatment A | Study visits were separated by 3-7 day intervals. Treatment C: 21ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 2; Treatment B: 42ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 3; Treatment A: 84ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 4 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Visit 2 (Randomization) |
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| Visit 3 |
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| Visit 4 |
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| Follow-up Visit (Final Visit) |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Patients | All patients that were enrolled 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 | Cmax of Budesonide After Administration of MAP0020 | The maximum concentration (Cmax) is the highest concentration of a drug measured in the plasma. Plasma is the clear portion of the blood. The Cmax of Budesonide is reported in picograms per milliliter (pg/ml). | Patients with available data at specified time points are included in the analysis population. | Posted | Mean | Standard Deviation | pg/ml | 12 hours |
|
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All 25 subjects who received 21ug MAP0020, 24 subjects who received 42ug MAP0020, and 24 subjects who received 84ug MAP0020 are included in the adverse event analysis.
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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 | 21ug MAP0020 | 21ug of unit dose budesonide inhalation suspension delivered by Aeroneb® Go (MAP0020) as per protocol |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| VP, Scientific Affairs | MAP Pharmaceuticals Inc., a wholly owned subsidiary of Allergan | 650-386-3100 | dkellerman@mappharma.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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|
| Treatment C, then Treatment A, then Treatment B | Experimental | Study visits were separated by 3-7 day intervals. Treatment C: 21ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 2; Treatment A: 84ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 3; Treatment B: 42ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 4 |
|
| Treatment C, then Treatment B, then Treatment A | Experimental | Study visits were separated by 3-7 day intervals. Treatment C: 21ug of unit dose budesonide delivered by Aeroneb® Go (MAP0020) at Visit 2; Treatment B: 42ug of unit dose budesonide delivered by Aeroneb® Go (MAP0020) at Visit 3; Treatment A: 84ug of unit dose budesonide delivered by Aeroneb® Go (MAP0020) at Visit 4 |
|
| 42ug MAP0020 | Drug | 42ug of unit dose budesonide inhalation suspension delivered by Aeroneb® Go (MAP0020) as per protocol |
|
| 21ug MAP0020 | Drug | 21ug of unit dose budesonide inhalation suspension delivered by Aeroneb® Go (MAP0020) as per protocol |
|
| San Antonio |
| Texas |
| United States |
| 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 |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG002 | 84ug MAP0020 | 84ug of unit dose budesonide delivered by Aeroneb® Go (MAP0020) as per protocol |
|
|
| Primary | AUC(0-inf) of Budesonide After Administration of MAP0020 | The AUC(0-inf) is the area under the plot of plasma concentration of drug to time infinity after drug administration. Budesonide AUC(0-inf) is reported in picograms times minutes per milliliter (pg*min/ml). | Patients with available data at specified time points are included in the analysis population. | Posted | Mean | Standard Deviation | pg*min/ml | 12 hours |
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|
|
| Primary | Half-life (t1/2) of Budesonide After Administration of MAP0020 | Half-life (t1/2) is the time for the drug to decrease to half of its maximum concentration. Budesonide t1/2 is reported in minutes. | Patients with available data at specified time points are included in the analysis population. | Posted | Mean | Standard Deviation | minutes | 12 hours |
|
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|
| 0 |
| 25 |
| 2 |
| 25 |
| EG001 | 42ug MAP0020 | 42ug of unit dose budesonide inhalation suspension delivered by Aeroneb® Go (MAP0020) as per protocol | 0 | 24 | 1 | 24 |
| EG002 | 84ug MAP0020 | 84ug of unit dose budesonide inhalation suspension delivered by Aeroneb® Go (MAP0020) as per protocol | 0 | 24 | 0 | 24 |
A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |