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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
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).
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.
University Hospital of Antwerp
Edegem, Antwerp, Belgium
Changes in the number of deposited particles of concomitant inhalation medication per pre-defined airway section
FRI parameters: HRCT scan will be taken at visit 1 and visit 3.
Time frame: At day 1 and after 15 +/- 3 days of treatment
Changes in Distal airway volumes (iVaw)
FRI parameters: HRCT scan will be taken at visit 1 and visit 3.
Time frame: At day 1 and after 15 +/- 3 days of treatment
Changes in Distal airway resistance (iRaw)
FRI parameters: HRCT scan will be taken at visit 1 and visit 3.
Time frame: At visit 1 and after 15 +/- 3 days of treatment
Changes in Lung and Lobe Volumes (iVlobes)
FRI parameters: HRCT scan will be taken at visit 1 and visit 3.
Time frame: At day 1 and after 15 +/- 3 days of treatment
Changes in Airway Wall Thickness (iVaww)
FRI parameters: HRCT scan will be taken at visit 1 and visit 3.
Time frame: At day 1 and after 15 +/- 3 days of treatment
Changes in Blood Vessel Density (iVbv)
FRI parameters: HRCT scan will be taken at visit 1 and visit 3.
Time frame: At day 1 and after 15 +/- 3 days of treatment
Changes in Air Trapping
FRI parameters: HRCT scan will be taken at visit 1 and visit 3.
Time frame: At day 1 and after 15 +/- 3 days of treatment
Changes in Forced Expiratory Volume in 1 Second (FEV1)
Spirometry parameter
Time frame: At day 1 and after 15 +/- 3 days of treatment
Changes in Forced Vital Capacity (FVC)
Spirometry parameter
Time frame: At day 1 and after 15 +/- 3 days of treatment
Changes in Peak Expiratory Flow (PEF)
Spirometry parameter
Time frame: At day 1 and after 15 +/- 3 days of treatment
Changes in Forced Expiratory Flow between 25% to 75% of FVC (FEF 25-75)
Spirometry parameter
Time frame: At day 1 and after 15 +/- 3 days of treatment
Changes in Inspiratory Capacity (IC)
Spirometry parameter
Time frame: At day 1 and after 15 +/- 3 days of treatment
Changes in Tiffeneau Index (FEV1/FVC ratio)
Spirometry parameter
Time frame: At day 1 and after 15 +/- 3 days of treatment
Changes in Functional Residual Capacity (FRC)
Body plethysmography parameter
Time frame: At day 1 and after 15 +/- 3 days of treatment
Changes in Total Lung Capacity (TLC)
Body plethysmography parameter
Time frame: At day 1 and after 15 +/- 3 days of treatment
Changes in Airway Resistance (Raw)
Body plethysmography parameters: Airway resistance
Time frame: At day 1 and after 15 +/- 3 days of treatment
Changes in Specific airway conductance (sGaw)
Body plethysmography parameters: Airway resistance
Time frame: At day 1 and after 15 +/- 3 days of treatment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.