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Tolerability and PK of Submicron Budesonide in Children 4 to 11 Years Old With Mild-To-Moderate Stable Asthma

NCT00995904 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2014-01-09

Study results available
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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.

Conditions

Interventions

DRUG

84ug MAP0020

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

DRUG

42ug MAP0020

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

DRUG

21ug MAP0020

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

Sponsors & Collaborators

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

    collaborator INDUSTRY

  • Allergan

    lead INDUSTRY

Principal Investigators

  • Paul Ratner, MD · Sylvana Research Associates

  • Ammar Hatab, MD · West Coast Clinical Trials LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
4 Years
Max Age
11 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2009-11-30
Completion
2009-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT00995904 on ClinicalTrials.gov