Trials / Terminated
TerminatedNCT00697697
A Study of 2 Doses of MAP0010 in Asthmatic Children
A Randomized, Double-blind, Active-controlled, Phase 3 Extension Study Investigating the Safety and Efficacy Over 40 Weeks of 2 Doses of MAP0010 in Asthmatic Children (12 Months to 8 Years Old at the Time of Enrollment Into the MAP0010-CL-P301 Study)
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 192 (actual)
- Sponsor
- Allergan · Industry
- Sex
- All
- Age
- 12 Months – 8 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to examine the safety of two doses of MAP0010 in asthmatic children, 12 months to 8 years of age, over a 40-week period.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | 0.135mg MAP0010 | 0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 40 weeks |
| DRUG | 0.25mg MAP0010 | 0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 40 weeks |
Timeline
- Start date
- 2008-04-01
- Primary completion
- 2009-08-01
- Completion
- 2009-12-01
- First posted
- 2008-06-16
- Last updated
- 2014-01-09
- Results posted
- 2013-10-23
Source: ClinicalTrials.gov record NCT00697697. Inclusion in this directory is not an endorsement.