BronchiectasisNCT02411981
Effects of Chest Physiotherapy (CPT) on Lung Clearance Index (LCI) in Non Cystic Fibrosis (CF) Bronchiectasis
A study testing Autogenic drainage in people with Bronchiectasis, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial summary
This study will investigate the effects of on technique of chest physiotherapy on pulmonary function. Effects of pulmonary function will be measured by the spirometry, body plethysmography and by the multiple breath nitrogen washout technique. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bronchiectasis
- What is being tested?
- Autogenic drainage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteBelgium
- Study dates
- Apr 2015to Feb 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Non cystic fibrosis bronchiectasis in stable state
Who cannot join
- Not in stable state
- Bronchiectasis with severe respiratory morbidities likely to reduce the chest physiotherapy session efficacy (e.g. : severe chronic obstructive pulmonary disease)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Short-term Effects of Chest Physiotherapy on Ventilation Inhomogeneity in Non-CF Bronchiectasis
This study will investigate the effects of on technique of chest physiotherapy on pulmonary function. Effects of pulmonary function will be measured by the spirometry, body plethysmography and by the multiple breath nitrogen washout technique.
Read the detailed description
This is a before-after intervention study.
Spirometry, body plethysmography and then multiple breath nitrogen washout will be measured before the application of chest physiotherapy.
The chest physiotherapy technique used will be autogenic drainage during 30 minutes. A resting period of 5 minutes will be given to the participant before the following tests.
Spirometry, body plethysmography and then multiple breath nitrogen washout will be measured again, in the same order, after the application of chest physiotherapy.
- Conditions
- Bronchiectasis
- Being tested
- Autogenic drainage
- Keywords
- Lung Clearance Index, Non cystic fibrosis Bronchiectasis, Multiple Breath Nitrogen Washout
- Medical subject headings
- Bronchiectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autogenic drainageOther
| Study group | Role | What they receive |
|---|---|---|
| Autogenic drainage | Other | The autogenic drainage will be the chest physiotherapy technique used for this study.
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. Receives: Other: Autogenic drainage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Lung Clearance Index (LCI)
LCI will me measured before and after the chest physiotherapy session
Measured: up to 80 minutes
Secondary outcomes (2)
Change of Spirometry
Forced expired volume in one second (FEV1) and Forced expired flow at 25-75% of the forced vital capacity (FEF25-75) will be measured before and after the chest physiotherapy session
Measured: up to 40 minutes
Sputum weight
Sputum will be collected during the 30 minutes of chest physiotherapy session and 5 minutes immediately after. Sputum weight will be measured and correlated with change of LCI and spirometry values
Measured: 35 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2015 (estimated)
- Study startApr 2015
- Primary completionOct 2015
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BronchiectasisStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Poncin, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
- Investigators
- Sophie Gohy, MD, PhD, Study director, Cliniques universitaires Saint-Luc- Université Catholique de LouvainWilliam Poncin, PhD student, Principal investigator, Cliniques universitaires Saint-Luc- Université Catholique de LouvainGrégory Reychler, PhD, Study chair, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02411981
- Sponsor's protocol ID
- StLuc MBWN2 03
- Status last verified
- Mar 2016
- First submitted
- 3 Apr 2015
- Last updated
- 22 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Poncin W, Reychler G, Leeuwerck N, Bauwens N, Aubriot AS, Nader C, Liistro G, Gohy S. Short-Term Effect of Autogenic Drainage on Ventilation Inhomogeneity in Adult Subjects With Stable Non-Cystic Fibrosis Bronchiectasis. Respir Care. 2017 May;62(5):524-531. doi: 10.4187/respcare.05194. Epub 2017 Feb 21.
PubMed 28223466
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-term Effects of Chest Physiotherapy on Ventilation Inhomogeneity in Non-CF Bronchiectasis
- ClinicalTrials.gov ID
- NCT02411981
- Acronym / sponsor ID
- StLuc MBWN2 03
- Conditions
- Bronchiectasis
- Keywords
- Lung Clearance Index, Non cystic fibrosis Bronchiectasis, Multiple Breath Nitrogen Washout
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 8 Apr 2015 (estimated)
- 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 on technique of chest physiotherapy on pulmonary function. Effects of pulmonary function will be measured by the spirometry, body plethysmography and by the multiple breath nitrogen washout technique.
Detailed description
This is a before-after intervention study.
Spirometry, body plethysmography and then multiple breath nitrogen washout will be measured before the application of chest physiotherapy.
The chest physiotherapy technique used will be autogenic drainage during 30 minutes. A resting period of 5 minutes will be given to the participant before the following tests.
Spirometry, body plethysmography and then multiple breath nitrogen washout will be measured again, in the same order, after the application of chest physiotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Autogenic drainage | Other | Other: Autogenic drainageThe autogenic drainage will be the chest physiotherapy technique used for this study. 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Non cystic fibrosis bronchiectasis in stable state
Key exclusion criteria (2 listed)
- Not in stable state
- Bronchiectasis with severe respiratory morbidities likely to reduce the chest physiotherapy session efficacy (e.g. : severe chronic obstructive pulmonary disease)
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 drainage | Other | Autogenic drainage |
Primary outcome
Change of Lung Clearance Index (LCI)
Time frame: up to 80 minutes
LCI will me measured before and after the chest physiotherapy session
2 secondary outcomes
Change of Spirometry
Time frame: up to 40 minutes
Sputum weight
Time frame: 35 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2016.
- Derived from this study: PubMed 28223466Poncin W, Reychler G, Leeuwerck N, Bauwens N, Aubriot AS, Nader C, Liistro G, Gohy S. Short-Term Effect of Autogenic Drainage on Ventilation Inhomogeneity in Adult Subjects With Stable Non-Cystic Fibrosis Bronchiectasis. Respir Care. 2017 May;62(5):524-531. doi: 10.4187/respcare.05194. Epub 2017 Feb 21.
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Bronchiectasis
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.
Sophie Gohy, MD, PhD study director
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
William Poncin, PhD student principal investigator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Grégory Reychler, PhD study chair
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 in people with Bronchiectasis, 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 1 inclusion and 2 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: finished, as of the sponsor's last update on 22 Mar 2016. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 of Lung Clearance Index (LCI) (time frame: up to 80 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02411981, which also lists 1 linked publication.
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 22 Mar 2016.