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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 and efficacy of two doses of MAP0010 versus placebo in asthmatic infants and children, 12 months to 8 years of age, over a 12-week treatment period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.25mg MAP0010 | Experimental | 0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks |
|
| Placebo | Placebo Comparator | Placebo delivered by nebulization twice daily for 12 weeks |
|
| 0.135mg MAP0010 | Experimental | 0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 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 12 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 7 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 12 |
| 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 7 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 12 |
| 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 and the largest volume from the 3 maneuvers was selected. An increase indicates an improvement (a greater volume of air expired). |
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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 | Placebo | Placebo delivered by nebulization twice daily for 12 weeks |
| FG001 | 0.135 mg MAP0010 | 0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks |
| FG002 | 0.25 mg MAP0010 | 0.125mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo delivered by nebulization twice daily for 12 weeks |
| BG001 | 0.135 mg MAP0010 | 0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 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 7 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. | Intent-to-treat includes all randomized patients who have received at least one dose of study drug and have baseline and at least one post treatment efficacy assessment available. | Posted | Mean | Standard Deviation | units on a scale | baseline, week 12 |
|
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All randomized patients who received at least one dose of study drug and who have at least one post dosing 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 | Placebo | Placebo delivered by nebulization twice daily for 12 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia Necrotising | Infections and infestations | MedDRA (10.1) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pyrexia | General disorders | MedDRA (10.1) | 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 |
| 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 12 weeks |
|
| Placebo | Drug | Placebo delivered by nebulization twice daily for 12 weeks |
|
| baseline, week 12 |
| Change From Baseline in PEF | The peak expiratory flow (PEF) is the highest air flow achieved from a maximum forced expiratory maneuver measured in liters of air per minute (L/min). Subjects had to perform at least 3 acceptable maneuvers into a PEF meter. An increase indicates an improvement (a greater volume of air expired). | baseline, week 12 |
| Change From Baseline in Daytime Individual Symptom Scores | 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 Individual Daytime symptom score is defined as an average of the last 5 days' individual symptom scores within the last 7 days immediately preceding the end day of that week. A negative change indicates an improvement of symptoms and a positive change indicates a worsening of symptoms. | baseline, week 12 |
| Change From Baseline in Nighttime Individual Symptom Scores | 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 Individual nighttime symptom score is defined as an average of the last 5 nights' individual symptom scores within the last 7 nights immediately preceding the end day of that week. A negative change indicates an improvement of symptoms and a positive change indicates a worsening of symptoms. | baseline, week 12 |
| BG002 | 0.25 mg MAP0010 | 0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Age, Continuous | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Placebo |
Placebo delivered by nebulization twice daily for 12 weeks |
| OG001 | 0.135 mg MAP0010 | 0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks |
| OG002 | 0.25 mg MAP0010 | 0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks |
|
|
| 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 and the largest volume from the 3 maneuvers was selected. An increase indicates an improvement (a greater volume of air expired). | The modified-intent-to-treat population includes all randomized patients who were deemed capable of spirometry measurements at baseline and at least at one of the post treatment visits. | Posted | Mean | Standard Deviation | percentage of predicted FEV1 | baseline, week 12 |
|
|
|
| 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 7 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. | Intent-to-treat includes all randomized patients who have received at least one dose of study drug and have baseline and at least one post treatment efficacy assessment available. | Posted | Mean | Standard Deviation | units on a scale | baseline, week 12 |
|
|
|
| Secondary | Change From Baseline in PEF | The peak expiratory flow (PEF) is the highest air flow achieved from a maximum forced expiratory maneuver measured in liters of air per minute (L/min). Subjects had to perform at least 3 acceptable maneuvers into a PEF meter. An increase indicates an improvement (a greater volume of air expired). | The modified-intent-to-treat population includes all randomized patients who were deemed capable of spirometry measurements at baseline and at least at one of the post treatment visits. | Posted | Mean | Standard Deviation | L/min | baseline, week 12 |
|
|
|
| Secondary | Change From Baseline in Daytime Individual Symptom Scores | 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 Individual Daytime symptom score is defined as an average of the last 5 days' individual symptom scores within the last 7 days immediately preceding the end day of that week. A negative change indicates an improvement of symptoms and a positive change indicates a worsening of symptoms. | Intent-to-treat includes all randomized patients who have received at least one dose of study drug and have baseline and at least one post treatment efficacy assessment available. | Posted | Mean | Standard Deviation | units on a scale | baseline, week 12 |
|
|
|
| Secondary | Change From Baseline in Nighttime Individual Symptom Scores | 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 Individual nighttime symptom score is defined as an average of the last 5 nights' individual symptom scores within the last 7 nights immediately preceding the end day of that week. A negative change indicates an improvement of symptoms and a positive change indicates a worsening of symptoms. | Intent-to-treat includes all randomized patients who have received at least one dose of study drug and have baseline and at least one post treatment efficacy assessment available. | Posted | Mean | Standard Deviation | units on a scale | baseline, week 12 |
|
|
|
| 1 |
| 110 |
| 33 |
| 110 |
| EG001 | 0.135 mg MAP0010 | 0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks | 2 | 123 | 31 | 123 |
| EG002 | 0.25 mg MAP0010 | 0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks | 0 | 123 | 42 | 123 |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Systematic Assessment |
|
| Upper Respiratory Tract Infections | Infections and infestations | MedDRA (10.1) | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Systematic Assessment |
|
| Nasopharyngitis | 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 |
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| Wheeze: Baseline |
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| Wheeze: Change from Baseline at week 12 |
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| Shortness of Breath: Baseline |
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| Shortness of Breath: Change from Baseline at Wk 12 |
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| Wheeze: Baseline |
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| Wheeze: Change from Baseline at week 12 |
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| Shortness of Breath: Baseline |
|
| Shortness of Breath: Change from Baseline at Wk 12 |
|