CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 360 enrolled
Drug / intervention
0.135mg MAP0010 +2 moredrug
Likely dose
0.135mg MAP0010from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00569192
NCT00569192Phase 3Completed
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A Randomized, Double Blind, Placebo Controlled, Parallel Group, Study Investigating the Safety and Efficacy Over 12 Weeks Treatment Period of MAP0010 in Asthmatic Infants and Children 12 Months to 8 Years of Age

Allergan·interventional·Posted Dec 7, 2007·Updated Jan 9, 2014

In Brief

A Phase 3 clinical trial evaluating 0.135mg MAP0010, 0.25mg MAP0010, and 1 other intervention for Asthma. Completed, enrolled 360 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
Countries--
CollaboratorsMAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 7, 2007
Enrollment StartDec 1, 2007
Primary CompletionSep 1, 2008
Study CompletionJan 1, 2009
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 18.6 years ago

Interventions

0.135mg MAP0010drug

0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks

0.25mg MAP0010drug

0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks

Placebodrug

Placebo delivered by nebulization twice daily for 12 weeks