CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 208 enrolled
Drug / intervention
MAP0010 low dose +2 moredrug
Likely dose
Not stated in 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/NCT00697801
NCT00697801Phase 2Completed
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A Randomized, Double Blind, Placebo Controlled, 3 Arm, Parallel Group, Phase 2 Study Investigating the Efficacy, Tolerability and Pharmacokinetics of MAP0010 in Asthmatic Children and Adolescents Over 6 Weeks

Allergan·interventional·Posted Jun 16, 2008·Updated Jan 9, 2014

In Brief

A Phase 2 clinical trial evaluating MAP0010 low dose, MAP0010 high dose, and 1 other intervention for Asthma. Completed, enrolled 208 participants across 1 site.

Detailed 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.

Study Details

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

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 16, 2008
Enrollment StartJul 1, 2006
Primary CompletionDec 1, 2006
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 18.0 years ago

Interventions

MAP0010 low dosedrug

a single dose of MAP0010 low dose delivered by nebulization twice daily for 6 weeks

MAP0010 high dosedrug

a single dose of MAP0010 high dose delivered by nebulization twice daily for 6 weeks

Placebodrug

Placebo delivered by nebulization twice daily for 6 weeks