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Effects of AD on VI in Patients With CF

Primary Purpose

Cystic Fibrosis

Status

Unknown status

Phase

Not Applicable

Locations

Belgium

Study Type

Interventional

Intervention

Autogenic drainage

Aerosoltherapy

About this trial

This is an interventional treatment trial for Cystic Fibrosis focused on measuring Multiple breath washout, Electrical impedance tomography, Lung clearance index, Chest physiotherapy, Autogenic drainage, Cystic fibrosis

Eligibility Criteria

6 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Cliniques universitaires Saint-LucRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Asl + CPT

Asl

Arm Description

Aerosotherapy + Autogenic drainage

Aerosoltherapy alone

Outcomes

Primary Outcome Measures

Change in Lung Clearance Index

LCI will be measured before, immediately after and 2h after the experimental or control conditions as well as before and after an hospitalization.

Secondary Outcome Measures

Impedance variation

Impedance change in different lung zones

Full Information

NCT ID

NCT03655249

First Posted

August 28, 2018

Last Updated

November 2, 2020

Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

1. Study Identification

Unique Protocol Identification Number

NCT03655249

Brief Title

Effects of AD on VI in Patients With CF

Official Title

Effects of Autogenic Drainage on Ventilation Inhomogeneity in Patients With Cystic Fibrosis

Study Type

Interventional

2. Study Status

Record Verification Date

November 2020

Overall Recruitment Status

Unknown status

Study Start Date

August 1, 2018 (Actual)

Primary Completion Date

December 2021 (Anticipated)

Study Completion Date

December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

This study will investigate the effects of a chest physiotherapy manual technique (autogenic drainage) on ventilation inhomogeneity in patients with cystic fibrosis. Lung clearance index (LCI) is the primary outcome

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cystic Fibrosis

Keywords

Multiple breath washout, Electrical impedance tomography, Lung clearance index, Chest physiotherapy, Autogenic drainage, Cystic fibrosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Model Description

Participants receive one of two interventions during the first day, and receive the alternative intervention the following day. Interventions are : aerosoltherapy + autogenic drainage or aerosoltherapy alone

Masking

None (Open Label)

Allocation

Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Asl + CPT

Arm Type

Experimental

Arm Description

Aerosotherapy + Autogenic drainage

Arm Title

Asl

Arm Type

Active Comparator

Arm Description

Aerosoltherapy alone

Intervention Type

Other

Intervention Name(s)

Autogenic drainage

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Aerosoltherapy

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in Lung Clearance Index

Description

LCI will be measured before, immediately after and 2h after the experimental or control conditions as well as before and after an hospitalization.

Time Frame

Up to 2 weeks

Secondary Outcome Measure Information:

Title

Impedance variation

Description

Impedance change in different lung zones

Time Frame

Up to 1 hour

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

William Poncin, PT, PhD

Phone

+3227642316

william.poncin@uclouvain.be

First Name & Middle Initial & Last Name or Official Title & Degree

Gregory Reychler, PT, PhD

Phone

+3227642316

gregory.reychler@uclouvain.be

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gregory Reychler, PT, PhD

Organizational Affiliation

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cliniques universitaires Saint-Luc

City

Brussels

ZIP/Postal Code

1200

Country

Belgium

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

William Poncin

william.poncin@uclouvain.be

12. IPD Sharing Statement

Learn more about this trial

Effects of AD on VI in Patients With CF

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