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

Phase 3

Completed

• Conditions: Asthma
• Interventions: Drug: 0.25mg MAP0010; Drug: Placebo; Drug: 0.135mg MAP0010

• Registration Number: NCT00569192
• Lead Sponsor: Allergan

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12
• Study First Submitted: 2007-12-05
• Study First Submitted QC: 2007-12-05
• Study First Posted: 2007-12-07
• Primary Completion: 2008-09
• Study Completion: 2009-01
• Results First Submitted: 2013-08-19
• Results First Submitted QC: 2013-08-19
• Results First Posted: 2013-10-23
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-09
• Last Update Posted: 2014-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 360

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
0.25mg MAP0010	0.25mg MAP0010	0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks
Placebo	Placebo	Placebo delivered by nebulization twice daily for 12 weeks
0.135mg MAP0010	0.135mg MAP0010	0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Daytime Composite Symptom Score	baseline, week 12	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.
Change From Baseline in Nighttime Composite Symptom Score	baseline, week 12	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.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Nighttime Individual Symptom Scores	baseline, week 12	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.
Change From Baseline in FEV1% Predicted	baseline, week 12	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).
Change From Baseline in PEF	baseline, week 12	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).
Change From Baseline in Daytime Individual Symptom Scores	baseline, week 12	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.