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| Name | Class |
|---|---|
| MAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan | INDUSTRY |
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The objectives of this study are to evaluate the efficacy, tolerability and pharmacokinetics of 2 doses of MAP0010 (Unit Dose Budesonide) in asthmatic children/adolescents.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MAP0010 low dose | Experimental | a single dose of MAP0010 low dose delivered by nebulization twice daily for 6 weeks |
|
| MAP0010 high dose | Experimental | a single dose of MAP0010 high dose delivered by nebulization twice daily for 6 weeks |
|
| Placebo | Placebo Comparator | Placebo delivered by nebulization twice daily for 6 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MAP0010 low dose | Drug | a single dose of MAP0010 low dose delivered by nebulization twice daily for 6 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Daytime Composite Symptom Score | The individual symptoms at each time point to be monitored are: cough, wheeze, and shortness of breath. The individual symptoms were scored using a four point scale: 0=no symptoms; 1=mild symptoms; 2=moderate symptoms; 3=severe symptoms Daily composite symptom score is based on the average of the individual symptom scores for a day. Daytime composite symptom score is defined as average of the last 5 days' daily composite symptom scores within the last 5 days immediately preceding the end day of that week. The range for the daytime composite symptom score is 0 (no symptoms) to 3 (severe symptoms). A negative change indicates an improvement of symptoms and a positive change indicates a worsening of symptoms. | baseline, week 6 |
| Change From Baseline in Nighttime Composite Symptom Score | The individual symptoms at each time point to be monitored are: cough, wheeze, and shortness of breath. The individual symptoms were scored using a four point scale: 0=no symptoms; 1=mild symptoms; 2=moderate symptoms; 3=severe symptoms Nightly composite symptom score is based on the average of the individual symptom scores for the night. Nightime composite symptom score is defined as average of the last 5 days' nightly composite symptom scores within the last 5 nights immediately preceding the end day of that week. The range for the nighttime composite symptom score is 0 (no symptoms) to 3 (severe symptoms). A negative change indicates an improvement of symptoms and a positive change indicates a worsening of symptoms. | baseline, week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in FEV1% Predicted | The forced expiratory volume in 1 second (FEV1) is the amount forced of air exhaled in 1 second. The percent predicted is calculated for age, gender, and height. Subjects had to perform at least 3 acceptable maneuvers into a spirometer. An increase indicates an improvement (a greater volume of air expired). | baseline, week 6 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | MAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Diego | California | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | MAP0010 High Dose | a single dose of MAP0010 high dose delivered by nebulization twice daily for 6 weeks |
| FG001 | MAP0010 Low Dose | a single dose of MAP0010 low dose delivered by nebulization twice daily for 6 weeks |
| FG002 | Placebo | Placebo delivered by nebulization twice daily for 6 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The baseline characteristics are summarized on the Intent-to-treat population (those patients with at least 1 on treatment efficacy evaluation including 1 electronic diary entry).
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| ID | Title | Description |
|---|---|---|
| BG000 | MAP0010 High Dose | a single dose of MAP0010 high dose delivered by nebulization twice daily for 6 weeks |
| BG001 | MAP0010 Low Dose | a single dose of MAP0010 low dose delivered by nebulization twice daily for 6 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 | Change From Baseline in Daytime Composite Symptom Score | The individual symptoms at each time point to be monitored are: cough, wheeze, and shortness of breath. The individual symptoms were scored using a four point scale: 0=no symptoms; 1=mild symptoms; 2=moderate symptoms; 3=severe symptoms Daily composite symptom score is based on the average of the individual symptom scores for a day. Daytime composite symptom score is defined as average of the last 5 days' daily composite symptom scores within the last 5 days immediately preceding the end day of that week. The range for the daytime composite symptom score is 0 (no symptoms) to 3 (severe symptoms). A negative change indicates an improvement of symptoms and a positive change indicates a worsening of symptoms. | Patients with available data at specified time points are included in the analysis population. | Posted | Mean | Standard Deviation | units on a scale | baseline, week 6 |
|
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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 | MAP0010 High Dose | a single dose of MAP0010 high dose delivered by nebulization twice daily for 6 weeks |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | 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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| MAP0010 high dose | Drug | a single dose of MAP0010 high dose delivered by nebulization twice daily for 6 weeks |
|
| Placebo | Drug | Placebo delivered by nebulization twice daily for 6 weeks |
|
| BG002 | Placebo | Placebo delivered by nebulization twice daily for 6 weeks |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
a single dose of MAP0010 high dose delivered by nebulization twice daily for 6 weeks |
| OG001 | MAP0010 Low Dose | a single dose of MAP0010 low dose delivered by nebulization twice daily for 6 weeks |
| OG002 | Placebo | Placebo delivered by nebulization twice daily for 6 weeks |
|
|
| Primary | Change From Baseline in Nighttime Composite Symptom Score | The individual symptoms at each time point to be monitored are: cough, wheeze, and shortness of breath. The individual symptoms were scored using a four point scale: 0=no symptoms; 1=mild symptoms; 2=moderate symptoms; 3=severe symptoms Nightly composite symptom score is based on the average of the individual symptom scores for the night. Nightime composite symptom score is defined as average of the last 5 days' nightly composite symptom scores within the last 5 nights immediately preceding the end day of that week. The range for the nighttime composite symptom score is 0 (no symptoms) to 3 (severe symptoms). A negative change indicates an improvement of symptoms and a positive change indicates a worsening of symptoms. | Patients with available data at specified time points are included in the analysis population. | Posted | Mean | Standard Deviation | units on a scale | baseline, week 6 |
|
|
|
| Secondary | Change From Baseline in FEV1% Predicted | The forced expiratory volume in 1 second (FEV1) is the amount forced of air exhaled in 1 second. The percent predicted is calculated for age, gender, and height. Subjects had to perform at least 3 acceptable maneuvers into a spirometer. An increase indicates an improvement (a greater volume of air expired). | Patients with available data at specified time points are included in the analysis population. | Posted | Mean | Standard Deviation | percentage of predicted FEV1 | baseline, week 6 |
|
|
|
| 0 |
| 69 |
| 21 |
| 69 |
| EG001 | MAP0010 Low Dose | a single dose of MAP0010 low dose delivered by nebulization twice daily for 6 weeks | 0 | 67 | 10 | 67 |
| EG002 | Placebo | Placebo delivered by nebulization twice daily for 6 weeks | 0 | 69 | 20 | 69 |
| Upper Respiratory Infection | Infections and infestations | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | 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 |
|
|