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A Study of 2 Doses of MAP0010 and Placebo in Asthmatic Children

NCT00569192 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2014-01-09

Study results available
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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.

Conditions

Interventions

DRUG

0.135mg MAP0010

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

DRUG

0.25mg MAP0010

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

DRUG

Placebo

Placebo delivered by nebulization twice daily for 12 weeks

Sponsors & Collaborators

  • MAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan

    collaborator INDUSTRY

  • Allergan

    lead INDUSTRY

Principal Investigators

  • Medical Director · MAP Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
12 Months
Max Age
8 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-12-31
Primary Completion
2008-09-30
Completion
2009-01-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00569192 on ClinicalTrials.gov