NCT01720680

Prospective Exploratory Study to Assess the Effects of the AlphaCore® Device in Patients With COPD

Open-label, Prospective Exploratory Study to Assess the Effects of the AlphaCore® Device on Central and Peripheral Airway Dimensions in Patients With COPD

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: University Hospital, Antwerp · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

* Title: Open-label, prospective exploratory study to assess the effects of the AlphaCore® device on central and peripheral airway dimensions in patients with COPD. * Indication: COPD patients * Study Design: Open-label, prospective design * Study Phase: II * Test treatment duration: 1 day * Test treatment: AlphaCore® device * Dosage regimen: 1 session of stimulation during 90 seconds * Patient number: up to 10 evaluable patients with COPD * Patient age: ≥ 18 years * Sex: male or female * Primary objective: The evaluation of the effect of the AlphaCore® device on central and peripheral airway dimensions with Computational Fluid Dynamics (CFD). * Secondary objectives: The assessment of the effect of the AlphaCore® device on lung function (spirometry, diffusion and resistance) and on patient reported outcomes (PRO's).

Conditions

• COPD

Interventions

Type	Name	Description
RADIATION	Low dose multislice CT thorax	All patients will have 2 low dose multi-slice CT's at visit 2: one CT "pre-dose" and one CT 1 to 3 hours "post-dose".
DEVICE	AlphaCore® device	All patients will receive a stimulation therapy of 90 seconds delivered by the AlphaCore.

Timeline

• Start date: 2012-10-01
• Primary completion: 2012-10-01
• Completion: 2012-12-01
• First posted: 2012-11-02
• Last updated: 2013-06-28

Locations

1 site across 1 country: Belgium