Bronchiolitis Obliteranse-PIBONCT06140901
Bronchial Epithelium of Children With Post-infectious Bronchiolitis Obliterans
A study testing Study morphological and functional of respiratory epithelium in people with Bronchiolitis Obliterans, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
Trial summary
Bronchiolitis obliterans (BO) is an irreversible chronic obstructive pulmonary pathology leading to obstruction and/or obliteration of the small airways. In children, the most common form of BO occurs following a serious lower respiratory tract infection. This is a rare complication; the incidence is unknown. Read more about this study
- Who is it for?
- Ages 1 month to 6 years
- Conditions the study is for
- Bronchiolitis Obliterans
- What is being tested?
- Study morphological and functional of respiratory epithelium
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 1 siteFrance
- Study dates
- 4 Dec 2023to 2 Aug 2027
- Phase
- Interventional
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 month to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children from 1 month to 6 years hospitalized at the Timone Enfant University Hospital
- Diagnosis of an adenovirus or rhinovirus respiratory infection confirmed on a nasal swab, made upon arrival as part of the child's initial care
- Consent form read, understood, approved and signed by parents before any study procedure
- Affiliation to a social security scheme or beneficiary of such a scheme
- The inclusion criteria for children who were not hospitalized when diagnosed with an adenovirus and rhinovirus respiratory infection at the Timone Enfant University Hospital are:
- Children from 1 month to 6 years old transferred to the Timone Enfant University Hospital
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- Show the following signs:
- has. Clinical: clinical signs persist 6 weeks after a viral infection: tachypnea, wheezing and/or persistent hypoxemia b. Scan: mosaic appearance +/- bronchiectasis, atelectasis vs. +/- EFR if performed: obstructive ventilatory disorder not or only slightly reversible after bronchodilators
- Consent form read, understood, approved and signed by parents before any study procedure
- Affiliation to a social security scheme or beneficiary of such a scheme
Who cannot join
- Refusal of participation in the study by the family will be a reason for non-inclusion, as well as in the absence of parental authority.
- The existence of an underlying chronic pulmonary pathology (e.g. cystic fibrosis, ciliary dyskinesia).
- A coagulation pathology.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Delphine Gras contact
France1 site, 1 recruiting
- Recruiting
APHM
Marseille, 13000
Julie MAZENQ, PhD, Julie.MAZENQ@ap-hm.fr
About this study
Official title: Morphological and Functional Pilot Study of the Bronchial Epithelium of Children With Post-infectious Bronchiolitis Obliterans
Bronchiolitis obliterans (BO) is an irreversible chronic obstructive pulmonary pathology leading to obstruction and/or obliteration of the small airways. In children, the most common form of BO occurs following a serious lower respiratory tract infection. This is a rare complication; the incidence is unknown. The diagnosis, often late, is made on clinical, spirometric and radiological arguments. The pathophysiology would be linked to damage to the airway epithelium. PIBO is most commonly associated with adenovirus (ADV) infection (serotypes 3, 7, 11 and 21) but also other viruses such as rhinovirus (RV). The treatment of PIBO is not clearly established, it remains empirical.
The research hypothesis is that the morphology of the nasal epithelium of children with ADV or RV infection is different for those progressing to PIBO. The main objective of the proposed observational study is to characterize damage to the respiratory epithelium in these children.
Read more
This is a single-center prospective longitudinal study (AP-HM), in children aged 1 month to 6 years, comparing children hospitalized for lower respiratory infection by ADV or RV progressing or not to PIBO. All children included will have a nasal swab and brushing on D0. Children developing PIBO will have nasal brushing with bronchial endoscopy with bronchial biopsies and bronchoalveolar washing at the time of PIBO diagnosis and again at M6 in case of partial response to treatment.
This is therefore a pilot study aimed at defining damage to the respiratory epithelium in children with PIBO following an ADV or RV infection and the role of respiratory epithelial cells in PIBO.
- Conditions
- Bronchiolitis Obliterans
- Being tested
- Study morphological and functional of respiratory epithelium
- Keywords
- children, post infectious
- Medical subject headings
- Bronchiolitis Obliterans
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Study morphological and functional of respiratory epitheliumDiagnostic test
The working's investigators hypothesis is that the morphology and functional of the epithelium of children with ADV or RV respiratory infection is different between those who progress to PIBO and those who do not.
| Study group | Role | What they receive |
|---|---|---|
| Arm non PIBO | Active comparator | children hospitalized for adenovirus or rhinovirus infection with non progressing to PIBO Receives: Diagnostic Test: Study morphological and functional of respiratory epithelium |
| Arm PIBO | Active comparator | Children hospitalized for adenovirus or rhinovirus infection with progressing to PIBO in evolution. Receives: Diagnostic Test: Study morphological and functional of respiratory epithelium |
What is being measured
The primary outcome is the main question the study is designed to answer.
The main objective is to define damage to the respiratory epithelium in children with PIBO following an Adenovirus (ADV) or Rhinovirus (RV) infection.
The morphology of the nasal and bronchial epithelia of PIBO will be analysed during the course of the disease both ex vivo and in vitro. Several criteria will be analysed, such as cell composition, thickness and epithelial cohesion during the culture of reconstituted nasal and/or bronchial epithelium, using microscopy.
Measured: through study completion, an average of 3 year
Secondary outcomes (4)
Looking for pro-inflammatory and antiviral mediators involved in remodelling and epithelial-mesenchymal transition or that may be involved in the development of a PIBO.
Dosage pro-inflammatory and antiviral mediators involved in remodeling and epithelial-mesenchymal transition. Level of expression of adenovirus and rhinovirus receptor: CAR, CD46, ICAM-1.
Measured: through study completion, an average of 3 year
Evaluating the response of the nasal epithelium to viral stimulation in children with and without PIBO and those who had not developed PIBO after respiratory infection with ADV and/or RV.
Quantifying the production of pro-inflammatory mediators with alarmins (TSLP, IL-33 and IL-25), cytokines (IL-6 and IL-8) and antivirals (IFN types I and III).
TSLP, IL-33, IL-25, IL-6 and IL-8, IFN types I and III will have the same units of measure.
Assay of PANoptosis markers with apoptosis, pyroptosis and necroptosis: caspase, GSDMD, MKL.
Measured: through study completion, an average of 3 year
Describing the transcriptomic profile of bronchial biopsies from children with PIBO.
An analysis of the transcriptome at the single-cell level will highlight the cellular heterogeneity of bronchial biopsies from children with OPDP, identify rare cell sub-populations and monitor the dynamics of cell evolution during development or as a function of its environment (cell interactions, pathogens, treatments, etc) by comparing them with databases of 'control' biopsies (FasteQ, Hu-man cell lungatlas).
Measured: through study completion, an average of 3 year
Following the morphology of the nasal and bronchial epithelia of PIBO over the course of the disease
Quantifying the production of pro-inflammatory mediators matory with alarmins (TSLP, IL-33 and IL-25), IL-6 and IL-8) and antivirals (IFN types I and III) with ELISA and western blot, involved in remodeling and epithelial-mesenchymal transition (FGF, EGF, TGF-alpha).
Measured: through study completion, an average of 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2023
- Study start4 Dec 2023
- Primary completion4 Dec 2026 (estimated)
- Study completion2 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchiolitis ObliteransStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This is a single-center prospective longitudinal study (AP-HM), in children aged 1 month to 6 years, comparing children hospitalized for lower respiratory infection by ADV or RV progressing or not to PIBO. After inclusion of the patients, a second nasal swab will be taken as part of the research for the PCR study of the subtypes of the virus responsible for the viral infection. Following the diagnosis of PIBO, bronchial endoscopy for microbiology and bronchial biopsies will be performed as part of routine care to rule out differential diagnoses. During this endoscopy, 2 additional bronchial biopsies and nasal brushing for research will be performed to recover epithelial cells.
- Masking
- None (open label)
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Julie MAZENQ, PhD, Principal investigator, APHP Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06140901
- Sponsor's protocol ID
- C23-37
- Other IDs
- 2023-A01544-41
- Acronym
- e-PIBO
- Status last verified
- Jul 2026
- First submitted
- 27 Oct 2023
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No