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Study of MAP0010 in Asthmatic Children and Adolescents

NCT00697801 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 208

Last updated 2014-01-09

Study results available
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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.

Conditions

Interventions

DRUG

MAP0010 low dose

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

DRUG

MAP0010 high dose

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

DRUG

Placebo

Placebo delivered by nebulization twice daily for 6 weeks

Sponsors & Collaborators

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

    collaborator INDUSTRY

  • Allergan

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-07-31
Primary Completion
2006-12-31
Completion
2006-12-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

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 NCT00697801 on ClinicalTrials.gov