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)
Sponsor study identifier
interventional
10
1 country
1
Study Start
December 2016
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 2017
Actual (reported)Study Completion
August 2017
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2017
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 13, 2016
Actual (reported)October 18, 2016
Actual (reported)December 2016
Date type not reportedThis date has not been verified as actual or estimated.
August 2017
Actual (reported)August 2017
Actual (reported)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.
At day 1 and after 15 +/- 3 days of treatment
Changes in Distal airway volumes (iVaw)
At day 1 and after 15 +/- 3 days of treatment
Changes in Distal airway resistance (iRaw)
At visit 1 and after 15 +/- 3 days of treatment
For a period of 15 +/- 3 days all 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). HRCT scans wil be taken at visit 1 and visit 3.
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).
University Hospital of Antwerp
Edegem, Antwerp, 2650, Belgium
Wilfried De Backer, MD, PhD
University Hospital of Antwerp
First Submitted
October 13, 2016
First Posted
October 18, 2016
Study Start
December 2016
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 2017
Actual (reported)Changes in Lung and Lobe Volumes (iVlobes)
At day 1 and after 15 +/- 3 days of treatment
Changes in Airway Wall Thickness (iVaww)
At day 1 and after 15 +/- 3 days of treatment
Changes in Blood Vessel Density (iVbv)
At day 1 and after 15 +/- 3 days of treatment
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Study Completion
August 2017
Actual (reported)Last Updated
October 3, 2017
Record last verified: 2017-10
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Source: ClinicalTrials.gov.
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