- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03655249
Effects of AD on VI in Patients With CF
Effects of Autogenic Drainage on Ventilation Inhomogeneity in Patients With Cystic Fibrosis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This is a cross-over intervention assessing the effect of autogenic drainage on ventilation inhomogeneity in patients with cystic fibrosis.
Electrical impedance tomography and multiple breath nitrogen washout will be performed before, immediatly after and 2h post intervention. Each participant will receive either aerosoltherapy alone or in combination with chest physiotherapy on 2 consecutive days.
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Brussels, Belgium, 1200
- Cliniques Universitaires Saint-Luc
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Cystic fibrosis diagnosis
- FEV1 > 40%
- Able to sustain 30min of chest physiotherapy
Exclusion Criteria:
- Presence of Burkoldheria cepacia or non tuberculous mycobacteria
- Orthopedic, neuromuscular or cardiac disorder likely to impact respiratory system
- Need for supplemental oxygen
- Cardiac pacemaker or internal cardiac defibrillator
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Asl + CPT
Aerosotherapy + Autogenic drainage
|
Autogenic drainage is an airway clearance technique that attempts to obtain the optimal airflow to evacuate the secretions.
This technique uses modulation of inspiratory and expiratory airflow at different breathing level within the vital capacity.
Aerosolized drugs are individualized for each participants, in line with current standardized practice in our hospital.
Those drugs will not be modified for the purpose of this study.
|
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Active Comparator: Asl
Aerosoltherapy alone
|
Aerosolized drugs are individualized for each participants, in line with current standardized practice in our hospital.
Those drugs will not be modified for the purpose of this study.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Lung Clearance Index
Time Frame: Up to 2 weeks
|
LCI will be measured before, immediately after and 2h after the experimental or control conditions as well as before and after an hospitalization.
|
Up to 2 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Impedance variation
Time Frame: Up to 1 hour
|
Impedance change in different lung zones
|
Up to 1 hour
|
Collaborators and Investigators
Investigators
- Principal Investigator: Gregory Reychler, PT, PhD, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018/22FEV/079
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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