NCT02936817

Study to Assess the Effect of the Aerobika Device in Addition to Standard of Care Treatment in Sputum Producing COPD Patients Using FRI

A Study to Assess the Effect of the Aerobika® Device in Addition to Standard of Care Treatment in Sputum Producing COPD Patients Using Functional Respiratory Imaging (FRI)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: FLUIDDA nv · Industry
• Sex: All
• Age: 40 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

Primary: The primary objective of this study is to evaluate the effect of the Aerobika® device on the aerosol deposition pattern of concomitant inhalation medication using FRI. Secondary: The secondary objective of this study is to evaluate the effect of the Aerobika® device on the airway volume (iVaw), lung and lobe volume (iVlobes), airway resistance (iRaw), hyperinflation, airway wall thickness (iVaww), blood vessel density (iVbv), and air trapping using FRI.

Conditions

• Pulmonary Disease, Chronic Obstructive
• COPD

Interventions

Type	Name	Description
DEVICE	Aerobika® Device	For a period of 15 +/- 3 days subjects will use the Aerobika® device before administration of their stable standard of care treatment regimen (i.e. study patients should use the device before each inhalation medication administration, with a minimum use of the device of twice daily).
RADIATION	HRCT scans	A HRCT scan at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) will be taken on visit 1, and visit 3. An upper airway (UA) scan will be taken on visit 1.

Timeline

• Start date: 2016-12-01
• Primary completion: 2017-08-01
• Completion: 2017-08-01
• First posted: 2016-10-18
• Last updated: 2017-10-03

Locations

1 site across 1 country: Belgium