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Assess Particle Deposition and Acute Effects of Symbicort® Forte Turbohaler®) in COPD Patients.

NCT01329276 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2011-04-05

No results posted yet for this study

Summary

Computational Fluid Dynamics (CFD) is a new functional imaging method. Since CFD is very sensitive to detect small changes, it might be worthwhile to study the acute effect of formoterol and budesonide combination therapy (Symbicort® forte Turbohaler®) on the upper airway dimensions in severe COPD patients (GOLD III). The increased sensitivity of this technique makes it possible to detect changes in airway caliber in early stages. The regional distribution of resistance and the change in this parameter will provide more insight into the mode of action of the product.

Conditions

Interventions

DRUG

Symbicort® forte Turbohaler®

320 µg budesonide / 9 µg formoterol fumarate dihydrate

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • University Hospital, Antwerp

    lead OTHER

Principal Investigators

  • Wilfried A De Backer, MD PhD · University Hospital, Antwerp

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2010-11-30
Completion
2011-01-31

Countries

  • Belgium

Study Locations

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Diseases
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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 NCT01329276 on ClinicalTrials.gov