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MAP0010 in Asthmatic Children and Adolescents
NCT00697801Phase 2
Key facts
- Status
- Completed
- Start
- Jul 2006
- Primary completion
- Dec 2006
- Countries
- 1
- Sponsor
- Allergan
- Modality
- Orthosteric Ligands
- Drugs
- budesonide
- Conditions
- asthma
01
Overview
Phase 2, randomised, double-blind trial of budesonide in asthma (3 arms), sponsored by Allergan. Primary endpoints: Change From Baseline in Daytime Composite Symptom Score at 6 weeks and Change From Baseline in Nighttime Composite Symptom Score at 6 weeks. Started Jul 2006; status: completed.
02
Design
3 arms- Study design
- RandomizedDouble-blind
MAP0010 low dose
MAP0010 low dose nebulized BID
MAP0010 high dose
MAP0010 high dose nebulized BID
Placebo
Placebo nebulized BID
03
Who it enrols
Asthmatic children and adolescents (1-18 years) with FEV1 >= 50% predicted, stable but symptomatic, excluding those with recent corticosteroid use or severe asthma history.
04
Endpoints
Primary
Change From Baseline in Daytime Composite Symptom Score
Change From Baseline in Nighttime Composite Symptom Score
Secondary
Change From Baseline in FEV1% Predicted
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