CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 25 enrolled
Drug / intervention
84ug MAP0020 +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/NCT00995904
NCT00995904Phase 2Completed
CompareCT.gov

A Randomized, Open-Label, 3-Dose, 3-Period, Crossover Phase 2 Study Investigating the Tolerability and Pharmacokinetics of MAP0010 in Children 4 Through 11 Years Old With a History of Mild-To-Moderate Stable Asthma

Allergan·interventional·Posted Oct 15, 2009·Updated Jan 9, 2014

In Brief

A Phase 2 clinical trial evaluating 84ug MAP0020, 42ug MAP0020, and 1 other intervention for Asthma. Completed, enrolled 25 participants across 2 sites.

Detailed 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.

Study Details

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

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 15, 2009
Enrollment StartSep 1, 2009
Primary CompletionNov 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 16.7 years ago

Interventions

84ug MAP0020drug

84ug of unit dose budesonide inhalation suspension delivered by Aeroneb® Go (MAP0020) as per protocol

42ug MAP0020drug

42ug of unit dose budesonide inhalation suspension delivered by Aeroneb® Go (MAP0020) as per protocol

21ug MAP0020drug

21ug of unit dose budesonide inhalation suspension delivered by Aeroneb® Go (MAP0020) as per protocol