Effects of AD on VI in Patients With CF

NCT03655249 | Withdrawn

• 1 other identifier: 2018/22FEV/079
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Conditions

Cystic Fibrosis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 2 weeks

Secondary Outcomes (1)

• Impedance variation

  Up to 1 hour

Study Arms (2)

Asl + CPT

EXPERIMENTAL

Aerosotherapy + Autogenic drainage

Other: Autogenic drainage; Drug: Aerosoltherapy

Asl

ACTIVE COMPARATOR

Aerosoltherapy alone

Drug: Aerosoltherapy

Interventions

Autogenic drainage OTHER

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.

Asl + CPT

Aerosoltherapy DRUG

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.

Asl; Asl + CPT

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Cystic fibrosis diagnosis
• FEV1 \> 40%
• Able to sustain 30min of chest physiotherapy

You may not qualify if:

• 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

Sponsors & Collaborators

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: lead

Study Sites (1)

Cliniques universitaires Saint-Luc

Brussels, 1200, Belgium

Location

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Officials

• Gregory Reychler, PT, PhD

  Cliniques universitaires Saint-Luc- Université Catholique de Louvain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: August 28, 2018
• First Posted: August 31, 2018
• Study Start: August 1, 2018
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: April 29, 2026

Record last verified: 2026-04

Locations

BE (1)