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A Study of 2 Doses of MAP0010 in Adult Asthmatics

NCT00554970 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2014-01-09

Study results available
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Summary

The purpose of this study is to examine the blood levels of two doses of MAP0010 (a corticosteroid) and two doses of an approved corticosteroid in adult asthma and safety with twice daily dosing over 7 days.

Conditions

Interventions

DRUG

MAP0010 low dose

a single dose of MAP0010 low dose delivered by nebulization twice daily for 7 days as per protocol

DRUG

MAP0010 high dose

a single dose of MAP0010 high dose delivered by nebulization twice daily for 7 days as per protocol

DRUG

Budesonide inhalation suspension 0.25mg

a single dose of Pulmicort Respules® 0.25mg delivered by nebulization twice daily for 7 days as per protocol

DRUG

Budesonide inhalation suspension 0.5mg

a single dose of Pulmicort Respules® 0.5mg dose delivered by nebulization twice daily for 7 days as per protocol

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
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2008-01-31
Completion
2008-03-31

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 NCT00554970 on ClinicalTrials.gov