Phase 3
Completed N=360
A Study of 2 Doses of MAP0010 and Placebo in Asthmatic Children
Source: ClinicalTrials.gov NCT00569192 ↗Enrolled (actual)
360
Serious AEs
0.8%
Results posted
Oct 2013
Primary outcomePrimary: Change From Baseline in Daytime Composite Symptom Score — 2.73; 2.96; 2.87; -1.38 units on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Daytime Composite Symptom Score |
2.73; 2.96; 2.87; -1.38; -1.77; -1.56 | — |
| PRIMARY Change From Baseline in Nighttime Composite Symptom Score |
2.71; 2.97; 2.82; -1.47; -1.82; -1.59 | — |
| SECONDARY Change From Baseline in FEV1% Predicted |
96.96; 91.20; 93.00; 1.51; 4.14; 0.36 | — |
| SECONDARY Change From Baseline in PEF |
170.94; 163.39; 165.34; 0.71; 20.10; 15.02 | — |
| SECONDARY Change From Baseline in Daytime Individual Symptom Scores |
1.16; 1.21; 1.18; -0.55; -0.68; -0.58 | — |
| SECONDARY Change From Baseline in Nighttime Individual Symptom Scores |
1.16; 1.20; 1.17; -0.59; -0.69; -0.61 | — |
Eligibility Criteria
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 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.
Data sourced from ClinicalTrials.gov (NCT00569192). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.