A Study of 2 Doses of MAP0010 and Placebo in Asthmatic Children

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, Double Blind, Placebo Controlled, Parallel Group, Study Investigating the Safety and Efficacy Over 12 Weeks Treatment Period of MAP0010 in Asthmatic Infants and Children 12 Months to 8 Years of Age

Conditions
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Asthma

Intervention / Treatment
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* Drug: 0.135mg MAP0010
* Drug: 0.25mg MAP0010
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female asthmatic children with mild to moderate persistent asthma. 12 months to 8 years of age. For children age 4 to 8 years: Documented diagnosis of asthma at least 3 months prior to Visit 1, per NIH (EPR-3) criteria. For infants age 12 to <48 months old: 2 or more wheezing episodes in past 12 months which lasted > 1 day and affected sleep. AND with at least one major or two minor risk factors. Exclusion Criteria: Any other significant childhood illness/abnormality or chronic lung disease Any history of upper or lower respiratory tract infection, within 2 weeks of screening. Any history of acute or severe asthma attack requiring ICU admission or ventilatory support. Use of any corticosteroid, including inhaled, parental, intranasal, or topical corticosteroid within 2 weeks of screening. Any use of oral corticosteroids within 30 days of screening or prolonged use (>10 consecutive days) of oral corticosteroids, within 12 weeks of screening.

Ages Eligible for Study
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Minimum Age: 12 Months
Maximum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 0.25mg MAP0010<br>0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks | Drug: 0.25mg MAP0010<br>* 0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks<br>|
| Placebo Comparator: Placebo<br>Placebo delivered by nebulization twice daily for 12 weeks | Drug: Placebo<br>* Placebo delivered by nebulization twice daily for 12 weeks<br>|
| Experimental: 0.135mg MAP0010<br>0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks | Drug: 0.135mg MAP0010<br>* 0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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). | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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asthmatic children