CClinicalTrials.gg
RecruitingNCT06987461BRONCHINIVUpdated May 23, 2025

Study of the Use of Non-invasive Ventilation in Bronchial Dilatation Disease

An observational study in Bronchial Dilatation Disease and Bronchectasie, sponsored by Centre Hospitalier Intercommunal Creteil. Recruiting at 5 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-23.

Sponsored by Centre Hospitalier Intercommunal Creteil · Observational

Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
70
Ages
18 Years and older
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Bronchial Dilatation Disease
  • Bronchectasie

Keywords

  • bronchial dilatation disease
  • Non-invasive ventilation
  • efficiency
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Population currently being treated for bronchial dilatation treated with long-term NIV

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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.
04

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
70 participants (estimated)
Patient registry
No

Groups and cohorts

  • Patients with bronchial dilatation treated with non-invasive ventilation

    Adult patients with predominantly cystic fibrosis bronchiectatic disease confirmed by tododensitometry, treated with NIV

05

What researchers measure

Primary outcomes

  1. epidemiological characteristics of the population with bronchial dilation under long-term NIV

    Time frame: Through study completion, an average of 1 year

  2. Reasons for placing under NIV

    Time frame: Through study completion, an average of 1 year

  3. Non-invasive ventilation adjustment modalities

    Time frame: Through study completion, an average of 1 year

Secondary outcomes

  1. Number of acute exacerbations (according to international recommendations) after initiation of NIV

    Time frame: Through study completion, an average of 1 year

  2. Stabilization of respiratory functional tests evolution of FEV1 (%, slope) of PaCO2

    Time frame: Through study completion, an average of 1 year

06

Study locations

2 of 5 sites recruiting
  • Centre Hospitalier Intercommunal de Créteil
    Créteil, 94000, France
    • Suela DEMIRI, Doctor, Hospital Practitioner · Contact · suela.demiri@chicreteil.fr · 01 57 02 29 63
    • Suela DEMIRI, Doctor, Hospital Practitioner · Principal investigator
    Recruiting
  • Centre Hospitalier Universitaire Henri Mondor
    Créteil, 94010, France
    • Frédéric SCHLEMMER, Lecturer hospital practitioner · Contact · frederic.schlemmer@aphp.fr · 01 49 81 23 78
    • Frédéric SCHLEMMER, Lecturer hospital practitioner · Principal investigator
    Recruiting
  • Centre Hospitalier Universitaire de Dijon
    Dijon, 21000, France
    • Marjolaine GEORGES, Doctor, Hospital Practitioner · Contact · marjolaine.georges@chu-dijon.fr · 08 90 43 40 86
    • Marjolaine GEORGES, Doctor, Hospital Practitioner · Principal investigator
    Not yet recruiting
  • Centre Hospitalier Universitaire de Rennes
    Rennes, 35000, France
    • Maria Alejandra GALARZA JIMENEZ, Doctor, Hospital Practitioner · Contact · Mariaalejandra.GALARZA.JIMENEZ@chu-rennes.fr · +33 2 99 28 43 21
    • Maria Alejandra GALARZA JIMENEZ, Doctor, Hospital Practitioner · Principal investigator
    Not yet recruiting
  • Centre Hospitalier Universitaire Toulouse
    Toulouse, 31059, France
    • Marion DUPUIS, Doctor, Hospital Practitioner · Contact · dupuis.m@chu-toulouse.fr · +33 5 67 77 18 58
    • Marion DUPUIS, Doctor, Hospital Practitioner · Principal investigator
    Not yet recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06987461
Lead sponsor
Centre Hospitalier Intercommunal Creteil
Responsible party
Sponsor
First posted
May 23, 2025
Start date
Jan 6, 2025
Primary completion
Dec 2025 (estimated)
Completion
Dec 2025 (estimated)
Last update
May 23, 2025

Study contacts

Suela DEMIRI, Doctor, Hospital Practitioner
Contact
suela.demiri@chicreteil.fr
01 57 02 29 63

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion