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
Overview
- Phase
- Phase 2
- Intervention
- MAP0010 low dose
- Conditions
- Asthma
- Sponsor
- Allergan
- Enrollment
- 208
- Primary Endpoint
- Change From Baseline in Nighttime Composite Symptom Score
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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.
Arms & Interventions
MAP0010 low dose
a single dose of MAP0010 low dose delivered by nebulization twice daily for 6 weeks
Intervention: MAP0010 low dose
MAP0010 high dose
a single dose of MAP0010 high dose delivered by nebulization twice daily for 6 weeks
Intervention: MAP0010 high dose
Placebo
Placebo delivered by nebulization twice daily for 6 weeks
Intervention: Placebo
Outcomes
Primary Outcomes
Change From Baseline in Nighttime Composite Symptom Score
Time Frame: baseline, week 6
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.
Change From Baseline in Daytime Composite Symptom Score
Time Frame: baseline, week 6
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.
Secondary Outcomes
- Change From Baseline in FEV1% Predicted(baseline, week 6)