Phase 2
Completed N=208
Study of MAP0010 in Asthmatic Children and Adolescents
Source: ClinicalTrials.gov NCT00697801 ↗Enrolled (actual)
208
Serious AEs
0.0%
Results posted
Oct 2013
Primary outcomePrimary: Change From Baseline in Daytime Composite Symptom Score — 3.1; 2.8; 2.6; -0.7 units on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Daytime Composite Symptom Score |
3.1; 2.8; 2.6; -0.7; -1.4; -0.6 | — |
| PRIMARY Change From Baseline in Nighttime Composite Symptom Score |
2.7; 2.4; 2.4; -0.6; -1.2; -0.4 | — |
| SECONDARY Change From Baseline in FEV1% Predicted |
74.8; 73.8; 65.9; 6.3; 6.3; 5.9 | — |
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.
Data sourced from ClinicalTrials.gov (NCT00697801). 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.