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

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

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.

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Drug: 0.25mg MAP0010; Drug: Placebo; Drug: 0.135mg MAP0010

• Study Type: Interventional
• Enrollment (Actual): 360
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 8 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Allergan
• Collaborators: MAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan
• Investigators: Study Director: Medical Director, MAP Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: December 1, 2007
• Primary Completion (Actual): September 1, 2008
• Study Completion (Actual): January 1, 2009

Study Registration Dates

• First Submitted: December 5, 2007
• First Submitted That Met QC Criteria: December 5, 2007
• First Posted (Estimate): December 7, 2007

Study Record Updates

• Last Update Posted (Estimate): January 9, 2014
• Last Update Submitted That Met QC Criteria: December 9, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: asthmatic children
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: MAP0010-CL-P301