NCT03784781

Brief Summary

The main objectives of this study are to show that the number of type 2 innate lymphoid cells (ILC2) of the bronchial mucosa and in bronchoalveolar lavages (BAL) are higher in asthmatic children than in non-asthmatics, that the number of ILC2 of the bronchial mucosa and in BAL correlate with the number of bronchial and BAL eosinophils, and to determine whether there is a correlation between plasma and bronchial and BAL ILC2.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 9, 2016

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

November 2, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 24, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2020

Completed
Last Updated

September 25, 2025

Status Verified

November 1, 2022

Enrollment Period

3.8 years

First QC Date

November 2, 2018

Last Update Submit

September 22, 2025

Conditions

Severe Asthma

Keywords

Severe asthma in childrenType 2 innate lymphoid cells (ILC2)bronchial mucosabronchoalveolar lavages

Outcome Measures

Primary Outcomes (1)

  • Number of type 2 innate lymphoid cells

    Type 2 innate lymphoid cells

    Day 0

Secondary Outcomes (11)

  • Number of Eosinophils

    Day 0

  • Airway remodeling: reticular basement membrane thickness

    Day 0

  • Airway remodeling: airway smooth muscle area

    Day 0

  • Airway remodeling: epithelial integrity

    Day 0

  • Airway remodeling: vessel number

    Day 0

  • +6 more secondary outcomes

Study Arms (2)

Asthmatic children

Severe uncontrolled asthma is defined by the need to maintain a treatment with high doses of inhaled corticosteroids and a long-acting bronchodilator (B2LDA) and/or an anti-leukotriene

Biological: BiopsyBiological: Blood collectionBiological: Bronchoalveolar lavage

Controls

Non-asthmatic children, paired in age, requiring bronchial endoscopy with BAL and bronchial mucosa biopsy.

Biological: BiopsyBiological: Blood collectionBiological: Bronchoalveolar lavage

Interventions

BiopsyBIOLOGICAL

Mucosal biopsies under general anesthesia of the segmental bronchi of the right or left lower lobe

Asthmatic childrenControls
Blood collectionBIOLOGICAL

Blood collection (+15mL/ current care)

Asthmatic childrenControls
Bronchoalveolar lavageBIOLOGICAL

Bronchoalveolar lavage fluid (3mL/Kg)

Asthmatic childrenControls

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Minors hospitalized in the department of pediatric pulmonology and allergy of Necker Hospital

You may qualify if:

  • Controls :
  • Minors aged 6 to 18 matched in age with severe asthmatic children
  • Non-asthmatic children hospitalized in the department of pediatric pulmonology and allergy in Necker Hospital
  • To undergo bronchial endoscopy with bronchoalveolar lavage, biopsy and blood collection
  • Severe asthmatic children :
  • Minors aged 6 to 18
  • Children hospitalized in the department of pediatric pulmonology and allergy in Necker Hospital
  • To undergo bronchial endoscopy with bronchoalveolar lavage, biopsy and blood collection
  • Severe uncontrolled asthma is defined by the need to maintain a treatment with high doses of inhaled corticosteroids and a long-acting bronchodilator (B2LDA) and/or an anti-leukotriene

You may not qualify if:

  • Children with an immune deficiency, will be excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Necker Enfants malades

Paris, 75015, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

Serum and tissue

MeSH Terms

Conditions

Asthma

Interventions

BiopsyBlood Specimen CollectionBronchoalveolar Lavage

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

CytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSpecimen HandlingDiagnostic Techniques, SurgicalSurgical Procedures, OperativeInvestigative TechniquesPuncturesTherapeutic Irrigation

Study Officials

  • Guillaume Lezmi, MD, PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 2018

First Posted

December 24, 2018

Study Start

June 9, 2016

Primary Completion

April 1, 2020

Study Completion

April 1, 2020

Last Updated

September 25, 2025

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)