Bronchial Dilatation DiseaseBRONCHINIVNCT06987461
Study of the Use of Non-invasive Ventilation in Bronchial Dilatation Disease
An observational study of Bronchial Dilatation Disease and Bronchectasie, run by Centre Hospitalier Intercommunal Creteil at 5 sites in France.
Trial summary
This is a medical record data collection study. The goal of this non-interventional and retrospective study is to describe the characteristics of the population currently being monitored for bronchial dilatation who have been treated with long-term NIV. This is a study based on data from medical records. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bronchial Dilatation Disease, Bronchectasie
- How many people
- 70 participants
- Where
- 5 sitesFrance
- Study dates
- 6 Jan 2025to Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Population currently being treated for bronchial dilatation treated with long-term NIV
Who may be able to join
- Patients over 18 years
- Predominant diagnosis of bronchiectatic disease, excluding cystic fibrosis, confirmed by computed tomography
- Introduction of long-term NIV at a given point in the patient's care
Who cannot join
- Patient's opposition to participating in this study
- Cystic fibrosis
- Predominant diagnosis of COPD or asthma, traction bronchiectasis, bronchiectasis resulting from focal endobronchial lesion, sarcoidosis or active allergic bronchopulmonary aspergillosis.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
France5 sites, 5 recruiting
- Recruiting
Centre Hospitalier Intercommunal de Créteil
Créteil, 94000
Suela DEMIRI, Doctor, Hospital Practitioner, 01 57 02 29 63, suela.demiri@chicreteil.fr
Suela DEMIRI, Doctor, Hospital Practitioner
- Recruiting
Centre Hospitalier Universitaire Henri Mondor
Créteil, 94010
Frédéric SCHLEMMER, Lecturer hospital practitioner, 01 49 81 23 78, frederic.schlemmer@aphp.fr
Frédéric SCHLEMMER, Lecturer hospital practitioner
- Not yet recruiting
Centre Hospitalier Universitaire de Dijon
Dijon, 21000
Marjolaine GEORGES, Doctor, Hospital Practitioner, 08 90 43 40 86, marjolaine.georges@chu-dijon.fr
Marjolaine GEORGES, Doctor, Hospital Practitioner
- Not yet recruiting
Centre Hospitalier Universitaire de Rennes
Rennes, 35000
Maria Alejandra GALARZA JIMENEZ, Doctor, Hospital Practitioner, +33 2 99 28 43 21, Mariaalejandra.GALARZA.JIMENEZ@chu-rennes.fr
Maria Alejandra GALARZA JIMENEZ, Doctor, Hospital Practitioner
- Not yet recruiting
Centre Hospitalier Universitaire Toulouse
Toulouse, 31059
Marion DUPUIS, Doctor, Hospital Practitioner, +33 5 67 77 18 58, dupuis.m@chu-toulouse.fr
Marion DUPUIS, Doctor, Hospital Practitioner
About this study
Official title: Study of the Use of Non-invasive Ventilation in Bronchial Dilatation Disease (BRONCHINIV)
This is a medical record data collection study. The goal of this non-interventional and retrospective study is to describe the characteristics of the population currently being monitored for bronchial dilatation who have been treated with long-term NIV. This is a study based on data from medical records.
The assessment criteria will be :
- Epidemiological characteristics of the population with bronchial dilatation on long-term NIV
- Reasons for initiation of NIV
- NIV adjustment methods
Read the detailed description
Non-invasive ventilation is a treatment sometimes used for severe severe bronchial dilatation, but to date there are no studies its efficacy.
The expected results in this context are :
- a description of the characteristics of patients with severe bronchial on non-invasive ventilation (NIV)
- a better understanding, during NIV management, of the settings used, the tolerance and effectiveness of NIV in reducing exacerbations, hospital admissions and patient mortality.
- move towards better patient management
Data will be extracted from patient medical records and the PMSI.
- Conditions
- Bronchial Dilatation Disease, Bronchectasie
- Keywords
- bronchial dilatation disease, Non-invasive ventilation, efficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with bronchial dilatation treated with non-invasive ventilation | Adult patients with predominantly cystic fibrosis bronchiectatic disease confirmed by tododensitometry, treated with NIV |
What is being measured
The primary outcome is the main question the study is designed to answer.
epidemiological characteristics of the population with bronchial dilation under long-term NIV
Measured: Through study completion, an average of 1 year
Reasons for placing under NIV
Measured: Through study completion, an average of 1 year
Non-invasive ventilation adjustment modalities
Measured: Through study completion, an average of 1 year
Secondary outcomes (2)
Number of acute exacerbations (according to international recommendations) after initiation of NIV
Measured: Through study completion, an average of 1 year
Stabilization of respiratory functional tests evolution of FEV1 (%, slope) of PaCO2
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2025
- Study start6 Jan 2025
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchial Dilatation DiseaseStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal Creteil
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06987461
- Sponsor's protocol ID
- BRONCHINIV
- Acronym
- BRONCHINIV
- Status last verified
- May 2025
- First submitted
- 17 Jan 2025
- Last updated
- 23 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Use of Non-invasive Ventilation in Bronchial Dilatation Disease (BRONCHINIV)
- ClinicalTrials.gov ID
- NCT06987461
- Acronym / sponsor ID
- BRONCHINIV / BRONCHINIV
- Conditions
- Bronchial Dilatation Disease, Bronchectasie
- Keywords
- bronchial dilatation disease, Non-invasive ventilation, efficiency
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Centre Hospitalier Intercommunal CreteilUniversity, hospital or other
- Study start
- 6 Jan 2025 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 23 May 2025 (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 is a medical record data collection study. The goal of this non-interventional and retrospective study is to describe the characteristics of the population currently being monitored for bronchial dilatation who have been treated with long-term NIV. This is a study based on data from medical records.
The assessment criteria will be :
- Epidemiological characteristics of the population with bronchial dilatation on long-term NIV
- Reasons for initiation of NIV
- NIV adjustment methods
Detailed description
Non-invasive ventilation is a treatment sometimes used for severe severe bronchial dilatation, but to date there are no studies its efficacy.
The expected results in this context are :
- a description of the characteristics of patients with severe bronchial on non-invasive ventilation (NIV)
- a better understanding, during NIV management, of the settings used, the tolerance and effectiveness of NIV in reducing exacerbations, hospital admissions and patient mortality.
- move towards better patient management
Data will be extracted from patient medical records and the PMSI.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with bronchial dilatation treated with non-invasive ventilation | – | –Adult patients with predominantly cystic fibrosis bronchiectatic disease confirmed by tododensitometry, treated with NIV |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Population currently being treated for bronchial dilatation treated with long-term NIV
Key inclusion criteria (3 listed)
- Patients over 18 years
- Predominant diagnosis of bronchiectatic disease, excluding cystic fibrosis, confirmed by computed tomography
- Introduction of long-term NIV at a given point in the patient's care
Key exclusion criteria (3 listed)
- Patient's opposition to participating in this study
- Cystic fibrosis
- Predominant diagnosis of COPD or asthma, traction bronchiectasis, bronchiectasis resulting from focal endobronchial lesion, sarcoidosis or active allergic bronchopulmonary aspergillosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
epidemiological characteristics of the population with bronchial dilation under long-term NIV
Time frame: Through study completion, an average of 1 year
Reasons for placing under NIV
Time frame: Through study completion, an average of 1 year
Non-invasive ventilation adjustment modalities
Time frame: Through study completion, an average of 1 year
2 secondary outcomes
Number of acute exacerbations (according to international recommendations) after initiation of NIV
Time frame: Through study completion, an average of 1 year
Stabilization of respiratory functional tests evolution of FEV1 (%, slope) of PaCO2
Time frame: Through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2025.
- Individual participant dataSharing planned: No
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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bronchial Dilatation Disease and Bronchectasie, run by Centre Hospitalier Intercommunal Creteil at 5 sites in France.
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 3 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: looking for participants now, as of the sponsor's last update on 23 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Suela DEMIRI, Doctor, Hospital Practitioner (01 57 02 29 63, suela.demiri@chicreteil.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
epidemiological characteristics of the population with bronchial dilation under long-term NIV (time frame: Through study completion, an average of 1 year). The study lists 3 primary outcomes in all. 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 23 May 2025; AzTrials last refreshed its copy on 8 Nov 2026.