Cystic FibrosisNCT03655249
Effects of AD on VI in Patients With CF
A study testing Autogenic drainage and Aerosoltherapy in people with Cystic Fibrosis, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial 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 Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Autogenic drainage and Aerosoltherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Aug 2018to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Cystic fibrosis diagnosis
- FEV1 > 40%
- Able to sustain 30min of chest physiotherapy
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Autogenic Drainage on Ventilation Inhomogeneity in Patients With Cystic Fibrosis
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
Read the 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.
- Conditions
- Cystic Fibrosis
- Being tested
- Autogenic drainage, Aerosoltherapy
- Keywords
- Multiple breath washout, Electrical impedance tomography, Lung clearance index, Chest physiotherapy, Autogenic drainage, Cystic fibrosis
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autogenic drainageOther
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.
AerosoltherapyDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Asl + CPT | Experimental | Aerosotherapy + Autogenic drainage Receives: Other: Autogenic drainage; Drug: Aerosoltherapy |
| Asl | Active comparator | Aerosoltherapy alone Receives: Drug: Aerosoltherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 2 weeks
Secondary outcomes (1)
Impedance variation
Impedance change in different lung zones
Measured: Up to 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2018
- Study start1 Aug 2018
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Why it stopped: No recruitement, no grant to support this study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gregory Reychler, PT, PhD, Principal investigator, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03655249
- Sponsor's protocol ID
- 2018/22FEV/079
- Status last verified
- Apr 2026
- First submitted
- 28 Aug 2018
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Autogenic Drainage on Ventilation Inhomogeneity in Patients With Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT03655249
- Acronym / sponsor ID
- 2018/22FEV/079
- Conditions
- Cystic Fibrosis
- Keywords
- Multiple breath washout, Electrical impedance tomography, Lung clearance index, Chest physiotherapy, Autogenic drainage, Cystic fibrosis
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No recruitement, no grant to support this study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 31 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Asl + CPT | Experimental | Other: Autogenic drainage, Drug: AerosoltherapyAerosotherapy + Autogenic drainage |
| Asl | Active comparator | Drug: AerosoltherapyAerosoltherapy alone |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Cystic fibrosis diagnosis
- FEV1 > 40%
- Able to sustain 30min of chest physiotherapy
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autogenic drainageAutogenic 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. | Other | Asl + CPT |
| AerosoltherapyAerosolized 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. | Drug | Asl, Asl + CPT |
Primary outcome
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.
1 secondary outcome
Impedance variation
Time frame: Up to 1 hour
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gregory Reychler, PT, PhD principal investigator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autogenic drainage and Aerosoltherapy in people with Cystic Fibrosis, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Lung Clearance Index (time frame: Up to 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.