drugset / Trial / NCT00995904
Tolerability and PK of Submicron Budesonide in Children 4 to 11 Years Old With Mild-To-Moderate Stable Asthma
Phase 2
Completed
25 enrolled
Allergan
MAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan · collab
RandomizedCrossoverOpen-labelTreatment
Summary
This Phase 2 study was to investigate the tolerability of unit dose budesonide (MAP0020) at three doses in pediatric volunteers with a diagnosis and history of mild-to-moderate stable asthma and evaluate the pharmacokinetic profile of budesonide resulting from inhalation aerosol delivery.
Timeline
- Start
- 2009-09
- Primary completion
- 2009-11
- Completion
- 2009-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Budesonide | Small molecule | 21 ug | Inhaled |
| Subject | Budesonide | Small molecule | 42 ug | Inhaled |
| Subject | Budesonide | Small molecule | 84 ug | Inhaled |