NCT04680117Completed
Defining the Severe Paediatric Asthma Endotype
Defining the Severe Paediatric Asthma Endotype: an Integrated Approach Combining Phenotypic Analyses Related to Immune, Metabolomics and Microbial Features
Source: ClinicalTrials.gov · Last updated 6 May 2026
Brief summary (registry, in English)
The primary objective of this project is to extensively characterize the endotypes of pre-schoolers (0 to 6 years) and school-age children (6 to 12 years) with SA using an integrated approach, combining a description of their phenotype (asthma symptoms, atopy, and lung function) associated with histological (airway inflammation and remodelling), immune (innate and adaptive immunity), metabolomics, and microbiota analyses. This goal shall be achieved by an unsupervised in-depth analysis of patients requiring bronchial endoscopy, with bronchial alveolar lavage (BAL) and bronchial biopsy, as part of their clinical assessment.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 54 (actual)
- First submitted
- 14 Sept 2020
- Start date
- 15 Jun 2021
- Primary completion date
- 24 Apr 2025
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Diseases
- Asthma
- NCT number
- NCT04680117
What you commit to
- Study type: Interventional
- Participants enrolled: 54
- From 15 Jun 2021 to the primary completion date, 24 Apr 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- Patient Inclusion Criteria:
- Minors aged 0 to 6 years or 6 to 12 years, hospitalized for assessment of Severe Asthma
- Minors need with his follow-up an bronchial endoscopy with realization of LBA and biopsies of bronchial mucosa
- Social insurance affiliation, except AME
- Parents or legal guardians signed the Informed consent form
- Control Inclusion Criteria:
- Minors aged 0 to 6 years or 6 to 12 years, hospitalized for assessment of severe respiratory syndrome except severe asthma
- Minors need with his follow-up an bronchial endoscopy with realization of LBA and biopsies of bronchial mucosa
- Social insurance affiliation, except AME
- Parents or legal guardians signed the Informed consent form
- Patient Exclusion Criteria
- Prematurity (\<37 weeks gestation)
- Broncho-pulmonary dysplasia, immune deficits, non-Severe Asthma bronchopathies, cystic fibrosis, heart disease, ongoing biotherapy
Age in the registry: - to 12 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Name: Hôpital Necker-Enfants Malades Coordinator of this site? Confirm its status | Paris | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.