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
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Allergan
- Enrollment
- 360
- Primary Endpoint
- Change From Baseline in Daytime Composite Symptom Score
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 12 Months to 8 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
0.25mg MAP0010
0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks
Intervention: 0.25mg MAP0010 (Drug)
Placebo
Placebo delivered by nebulization twice daily for 12 weeks
Intervention: Placebo (Drug)
0.135mg MAP0010
0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks
Intervention: 0.135mg MAP0010 (Drug)
Outcomes
Primary Outcomes
Change From Baseline in Daytime Composite Symptom Score
Time Frame: 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
Time Frame: 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 Outcomes
- Change From Baseline in Nighttime Individual Symptom Scores(baseline, week 12)
- Change From Baseline in FEV1% Predicted(baseline, week 12)
- Change From Baseline in PEF(baseline, week 12)
- Change From Baseline in Daytime Individual Symptom Scores(baseline, week 12)