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Phase4/Symbicort® Versus Pulmicort Flexhaler® in African Americans

NCT00702325 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 311

Last updated 2012-11-09

Study results available
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Summary

To compare the efficacy of SYMBICORT® pMDI 160/4.5 μg x 2 actuations twice daily (bid) to that of budesonide inhalation powder DPI 180 μg x 2 inhalations bid, in African American(self-reported) subjects with inhaled corticosteroid (ICS) dependent asthma.

Conditions

Interventions

DRUG

Budesonide / formoterol fumarate (SYMBICORT)

160/4.5 μg x 2 actuations twice daily (bid)

DRUG

Budesonide

inhalation powder 180 μg x 2 inhalations bid (PULMICORT)

Sponsors & Collaborators

Principal Investigators

  • Ubaldo Martin, MD · AstraZeneca

  • Tomas LG Andersson · AstraZeneca

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2009-09-30
Completion
2009-09-30

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

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 NCT00702325 on ClinicalTrials.gov