Study of MAP0010 in Asthmatic Children and Adolescents

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, Double Blind, Placebo Controlled, 3 Arm, Parallel Group, Phase 2 Study Investigating the Efficacy, Tolerability and Pharmacokinetics of MAP0010 in Asthmatic Children and Adolescents Over 6 Weeks

Conditions
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Asthma

Intervention / Treatment
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* Drug: MAP0010 low dose
* Drug: MAP0010 high dose
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female asthmatic children/adolescents 1 to 18 years of age FEV1 greater than or equal to 50% predicted normal (where obtainable) Stable but symptomatic Diagnosis of asthma (per NIH criteria) at least 3 months before screening OR documented exacerbation or worsening of asthma or symptoms suggestive of asthma including nocturnal asthma, within 6 months of screening OR documented SAB use more than or at least once for symptom relief during the 4 days of run in with a total symptom score greater than or equal to 1 OR greater than or equal to 1 night disturbed due to asthma symptoms in previous month. Exclusion Criteria: Any other significant childhood illness. Participated in any investigational clinical trial within the 30 days prior to screening. Use of any corticosteroid within 2 weeks of screening. Use of oral corticosteroid within 30 days of screening or prolonged use of oral corticosteroids within 12 weeks of screening. Use of inhaled long acting bronchodilators. Presumptive or documented history of upper or lower respiratory infection within 2 weeks before screening. Any history of acute or severe asthma attack requiring ICU admission or ventilatory support. History suggestive (or diagnosis) of other concomitant lung disease.

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 18 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: MAP0010 low dose<br>a single dose of MAP0010 low dose delivered by nebulization twice daily for 6 weeks | Drug: MAP0010 low dose<br>* a single dose of MAP0010 low dose delivered by nebulization twice daily for 6 weeks<br>|
| Experimental: MAP0010 high dose<br>a single dose of MAP0010 high dose delivered by nebulization twice daily for 6 weeks | Drug: MAP0010 high dose<br>* a single dose of MAP0010 high dose delivered by nebulization twice daily for 6 weeks<br>|
| Placebo Comparator: Placebo<br>Placebo delivered by nebulization twice daily for 6 weeks | Drug: Placebo<br>* Placebo delivered by nebulization twice daily for 6 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 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 | 

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. An increase indicates an improvement (a greater volume of air expired). | baseline, week 6 |