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Corporate decision
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| Name | Class |
|---|---|
| MAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan | INDUSTRY |
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The purpose of this study is to examine the safety of two doses of MAP0010 in asthmatic children, 12 months to 8 years of age, over a 40-week period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.135mg MAP0010 | Experimental | 0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 40 weeks |
|
| 0.25mg MAP0010 | Experimental | 0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 40 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.135mg MAP0010 | Drug | 0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 40 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Treatment Emergent Adverse Events Related to Study Drug | A treatment emergent adverse event is one with a start date on or after the date of first administration of the study drug during the study. | 40 weeks |
| Number of Patients Reporting at Least One Treatment Emergent Adverse Event Leading to Study Termination | A treatment emergent adverse event is one with a start date on or after the date of first administration of the study drug during the study. | 40 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | MAP Pharmaceuticals | Study Director |
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| ID | Title | Description |
|---|---|---|
| FG000 | 0.135mg MAP0010 | 0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 40 weeks |
| FG001 | 0.25mg MAP0010 | 0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 40 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Subjects were randomly assigned to treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | 0.135mg MAP0010 | 0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 40 weeks |
| BG001 | 0.25mg MAP0010 | 0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 40 weeks |
| 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 | Number of Patients With Treatment Emergent Adverse Events Related to Study Drug | A treatment emergent adverse event is one with a start date on or after the date of first administration of the study drug during the study. | All patients who received any study drug and who had at least one post safety evaluation were included in the adverse event analysis. | Posted | Number | participants | 40 weeks |
|
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All patients who received any study drug and who had at least one post safety evaluation were 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 | 0.135mg MAP0010 | 0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 40 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acquired hydrocele | Reproductive system and breast disorders | MedDRA 10.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pyrexia | General disorders | MedDRA (10.1) | Systematic Assessment |
The study was terminated due to a corporate decision before all subjects had completed the study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| VP, Scientific Affairs | MAP Pharmaceuticals, Inc. a wholly owned subsidiary of Allergan | 650-386-3100 | dkellerman@mappharma.com |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| 0.25mg MAP0010 | Drug | 0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 40 weeks |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Age, Continuous | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Primary | Number of Patients Reporting at Least One Treatment Emergent Adverse Event Leading to Study Termination | A treatment emergent adverse event is one with a start date on or after the date of first administration of the study drug during the study. | All patients who received any study drug and who had at least one post safety evaluation were included in the adverse event analysis. | Posted | Number | participants | 40 weeks |
|
|
|
| 0 |
| 94 |
| 71 |
| 94 |
| EG001 | 0.25mg MAP0010 | 0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 40 weeks | 1 | 98 | 85 | 98 |
| Pharyngitis | Infections and infestations | MedDRA (10.1) | Systematic Assessment |
|
| Pharyngitis streptococcal | Infections and infestations | MedDRA (10.1) | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA (10.1) | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA (10.1) | Systematic Assessment |
|
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA (10.1) | Systematic Assessment |
|
| Viral Infection | Infections and infestations | MedDRA (10.1) | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Systematic Assessment |
|
| Rhinitis Allergic | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA (10.1) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (10.1) | Systematic Assessment |
|
| Otitis Media | Infections and infestations | MedDRA (10.1) | Systematic Assessment |
|
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 |