NCT01329276

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

A Randomized, Double-blind, Placebo-controlled, Two Way Cross-over Study to Assess the Particle Deposition and Acute Effects of Formoterol and Budesonide Combination Therapy (Symbicort® Forte Turbohaler®) on the Upper Airway Dimensions in COPD Patients.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: University Hospital, Antwerp · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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

• Chronic Obstructive Pulmonary Disease

Interventions

Type	Name	Description
DRUG	Symbicort® forte Turbohaler®	320 µg budesonide / 9 µg formoterol fumarate dihydrate

Timeline

• Start date: 2010-06-01
• Primary completion: 2010-11-01
• Completion: 2011-01-01
• First posted: 2011-04-05
• Last updated: 2011-04-05

Locations

1 site across 1 country: Belgium