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COPD (Chronic Obstructive Pulmonary Disease)BRISENCT07780630

Creation of a Biological Collection of BRonchiaI and Pulmonary Tissues From Surgical wastE

An observational study of COPD (Chronic Obstructive Pulmonary Disease) and Asthma (Diagnosis), run by University Hospital, Bordeaux at 1 site in France.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

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Trial summary

The biological samples and associated data will facilitate the successful implementation of the research collaboration between Bordeaux University Hospital and the University of Bordeaux on the pathophysiology of bronchopulmonary diseases. Read more about this study

Who is it for?
Ages 1 year to 80 yearsHealthy volunteers can take part
What is being tested?
Fiberscopic samples, Sputum and Nasal brushing
Type of treatment
Surgery or procedure
How many people
650 participants
Where
1 siteFrance
Study dates
1 Sep 2026to 31 Dec 2028
How long will I take part?
1 Day
Phase
Observational

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 1 year to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Study population: The population includes male and female participants of all ages (adults and children) who are undergoing or require specific thoracic or bronchial procedures, sputum, nasal brushing, blood as part of clinical care or research. These procedures are conducted under the auspices of Bordeaux University Hospital (e.g., ARISE, BIRDIES, ICEBERG, VIRCHILLD) or Inserm (e.g., COBRA).

Who may be able to join

  • Male or female
  • Adult or children
  • Having required or necessitating, in the context of care or research involving the human person promoted by the Bordeaux University Hospital (ARISE, BIRDIES, ICEBERG, VIRCHILLD) or by Inserm (COBRA), either thoracic surgery such as lobectomy, pneumonectomy or lung transplantation in the Thoracic Surgery Department of the Haut Lévêque Hospital, or bronchial fiberscopy with biopsies and/or bronchial brushing and/or BAL at the children's hospital of the Pellegrin Hospital or at the Haut Lévêque Hospital.
  • Having received or, for children whose holders of parental authority have received, an information note with the possibility of opposition in accordance with the MR004 (French law - Commission Nationale de l'Informatique et des Libertés (CNIL))

Who cannot join

  • Patient or holder of parental authority for children who have expressed their opposition to participation in the research

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Patrick BERGER, MD, PhD contact

+33 5 47 30 27 50

patrick.berger@u-bordeaux.fr

France1 site
  • CHU de Bordeaux

    Pessac, 33604

    Patrick BERGER, PUPH, (+33)05 57 65 65 13

    Patrick BERGER, MD, PhD

Other trials in France

About this study

The biological samples and associated data will facilitate the successful implementation of the research collaboration between Bordeaux University Hospital and the University of Bordeaux on the pathophysiology of bronchopulmonary diseases. In the longer term, this research could lead to the discovery of new therapeutic targets for asthma, chronic obstructive pulmonary disease (COPD), pulmonary hypertension, and acute respiratory distress syndrome.

Read the detailed description

Bronchial obstructive diseases, such as asthma and chronic obstructive pulmonary disease (COPD), are very common and pose a major public health problem. Asthma affects about 7% and COPD affects 3% of the population in France. In children, the prevalence of asthma is even higher and can reach 15 to 20%. These two diseases are responsible for many hospitalizations and emergency room stays. While asthma mortality has been considerably reduced over the last 30 years, COPD mortality continues to increase to reach the 3rd leading cause of mortality. In COPD, pulmonary hypertension (PH) is a common comorbidity that increases mortality.

In each of these diseases, bronchial remodeling occurs from the beginning of the disease, including in children. Long considered an abnormal process of tissue repair after inflammation, it is now considered to be concomitant with bronchial inflammation. It conditions the prognosis of the disease but its pathophysiological processes remain largely unknown.

In asthma, bronchial remodeling is characterized by epithelial abrasion, pseudo-thickening of the basement membrane, bronchial fibrosis, hypertrophy of the submucosal glands, neoangiogenesis and increased bronchial smooth muscle mass. In the laboratory, the investigators have shown that the mechanisms responsible for this increase in bronchial smooth muscle mass are complex and involve in particular the mitochondria of bronchial smooth muscle in both adults and children.

In COPD, bronchial remodeling is characterized by epithelial metaplasia, hypertrophy of the submucosal glands, peribronchial fibrosis, and increased bronchial smooth muscle mass.

In the laboratory, it has been shown that fibrocytes are involved in peribronchial fibrosis. In addition, at the level of the lung parenchyma, there is a destruction of the distal airway spaces responsible for pulmonary emphysema. In some COPD patients, pulmonary hypertension occurs and is accompanied by remodeling of the pulmonary arteries with thickening of the media, and pulmonary arterial fibrosis.

Apart from adult acute respiratory distress syndrome (ARDS), it is an acute disease with a high risk of secondary pulmonary fibrosis. This is characterized by alveolar fibrosis with a proliferation of fibroblasts.

The COBRA cohort (Bronchial Obstruction and Asthma Cohort), sponsored by INSERM, makes it possible to obtain, with the consent of patients, bronchial tissues, blood, sputum of adult asthma or COPD patients from bronchial biopsies and brushing, Boncho-Alveolar lavage (BAL) obtained during bronchial fiberscopies, blood, sputum.

The results of experiments on asthmatic tissues should be compared with those from non-asthmatic subjects. In adults, these tissues come from surgical waste during lobectomy/pneumonectomy or lung transplantation. In children, these tissues are collected as part of the ARISE, BIRDIES, VIRCHILLD and more recently ICEBERG protocols (all promoted by the Bordeaux University Hospital) which make it possible to perform bronchial brushing and/or bronchial biopsies during bronchial fiberscopy, nasal brushing, surgical waste during a lobectomy and blood. These tissues thus make it possible to cultivate these same smooth muscle cells and bronchial epithelial cells. Adult surgical waste also makes it possible to grow cells from COPD patients at different stages of severity. They also make it possible to extract and culture other cell types involved in the pathophysiology of COPD such as fibrocytes, pneumocytes, endothelial and pulmonary vascular smooth muscle cells and other inflammatory cells such as lymphocytes, neutrophils, macrophages, mast cells, etc. This is because the immune cells in lung tissue are different from those in circulating blood. All of these cell types can be cultured in organoid models of bronchi, alveoli, submucosal glands, or even pulmonary vessels.

Depending on the respiratory function of the operated patients, measured pre-operatively, the bronchial/parenchymal and arterial pulmonary tissues may reflect a "healthy" tissue (non-asthmatic, non-COPD) or mild to severe COPD with or without pulmonary hypertension.

Being tested
Fiberscopic samples, Sputum, Nasal brushing, blood sampling
Medical subject headings
Pulmonary Disease, Chronic Obstructive, Asthma, Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fiberscopic samplesProcedure or surgery

    Perform brushing and/or bronchial biopsies and/or BAL and/or aspiration during bronchial fiberscopy and surgical waste during a lobectomy.

  • SputumProcedure or surgery

    Sputum has been collected for biological analysis.

  • Nasal brushingProcedure or surgery

    Nasal brushing is a minimally invasive medical procedure used to collect cellular samples from the nasal lining by gently rubbing a small cytology brush against the mucosa.

  • blood samplingProcedure or surgery

    Blood sampling is the safe collection of a blood specimen from a vein, finger, or artery to run medical lab tests

Study groups in NCT07780630
Study groupRoleWhat they receive
Patient with COPDNot described
Receives: Procedure: Fiberscopic samples; Procedure: Sputum; Procedure: blood sampling
Patient with AsthmaNot described
Receives: Procedure: Fiberscopic samples; Procedure: Sputum; Procedure: Nasal brushing; Procedure: blood sampling
Healthy volunteerNot described
Receives: Procedure: Fiberscopic samples

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Describe tobacco consumption

    Number pack in years

    Measured: At enrollment

  2. Describe tobacco statut

    Described as either non-smokers, former smokers or current smokers

    Measured: At enrollment

  3. Description of demographic status

    Gender (male or female)

    Measured: At enrollment

  4. Description of demographic status

    Age as years

    Measured: At enrollment

  5. Description of demographic status

    Body Mass Index (BMI) (kg/m^2)

    Measured: At enrollment

  6. Mesure of lung function parameters

    FEV1: forced expiratory volume in 1 sec

    Measured: At enrollment

  7. Mesure of lung function parameters

    FVC: forced vital capacity

    Measured: At enrollment

  8. Mesure of lung function parameters

    FEF25-75: forced expiratory flow between 25 and 75% of the FVC

    Measured: At enrollment

  9. Mesure of lung function parameters

    TLC: total lung capacity

    Measured: At enrollment

  10. Mesure of lung function parameters

    RV: residual volume

    Measured: At enrollment

  11. Describe of disease status

    Described as Healthy, COPD or Asthma

    Measured: At enrollment

  12. Collection type

    Described as bronchial or lung specimens (frozen of embedded in paraffin), bronchial smooth muscle cells, bronchial epithelial cells, alveolar cells, arterial smooth muscle cells, arterial endothelial cells, fibrocytes, mesenchymal cells, lymphocytes, neutrophils, macrophages, organoïds.

    Measured: At enrollment

Secondary outcomes (3)
  1. Mesure of blood gas parameter

    PaO2: arterial pressure in oxygen,

    Measured: At enrollment

  2. Mesure of blood gas parameter

    PaCO2: arterial pressure in carbon dioxide

    Measured: At enrollment

  3. Mesure of blood gas parameter

    pH

    Measured: At enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Aug 2026
  2. Study start1 Sep 2026 (estimated)
  3. Primary completion31 Dec 2028 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

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
Prospective
Enrolment
650 participants (estimated)
Target duration
1 Day
IDs, dates and publications
ClinicalTrials.gov ID
NCT07780630
Sponsor's protocol ID
CHUBX 2025/117
Acronym
BRISE
Status last verified
Aug 2026
First submitted
12 Jun 2026
Last updated
21 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The data is available from Pr BERGER . An email can be sent to him so that he can contact the data manager and owner, the Bordeaux University Hospital. The data can be made available after contractual agreement.

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