Inflammatory and Immune Profiles During a Severe Exacerbation in Preschool Asthmatic Children (<5 Years)

NCT03960359 | Active Not Recruiting

• 2 other identifiers: 2014_202014-A01687-40
• Study Type: observational
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief Summary

Asthma/wheeze begins in the first years of life and is the most common chronic disease in preschool children (\< 5 years). Different phenotypes have been suggested: Episodic-Viral Wheeze (EVW), absence of symptoms between exacerbations, among which Severe Intermittent Wheeze (SIW); and Multiple-trigger wheeze (MTW). The determinants of these different clinical phenotypes and their evolution have been poorly studied. The purpose of this study is to assess preschool wheezers at the time of a severe exacerbation: clinical features and biological determinants (virus/bacteria, molecules and cells involved in the inflammation) and at steady state (8 weeks later) and to follow them up until the age of 7. The investigators hypothesize that the nature of the inflammation at the time of the exacerbation is different between these clinical phenotypes and may be associated with different clinical and functional trajectories

Conditions

Asthma

Keywords

Asthma; wheeze; preschool; phenotype

Outcome Measures

Primary Outcomes (1)

• Inflammatory profile at exacerbation

  concentration levels of IFNg, IL-5, IL-13, IL-33, TSLP in blood and induced sputum (all concentrations expressed in pg/ml, obtained with multiplex assays) between wheeze patterns: EVW (among which SIW) vs MTW

  At the time of the inclusion

Secondary Outcomes (28)

• Inflammatory profile at steady state

  at baseline: consult at least 8 weeks after exacerbation

• Change of inflammatory profile between exacerbation and steady state

  At the time of the inclusion and at baseline (consult at least 8 weeks after exacerbation)

• Levels of cytokines in blood

  At the time of the inclusion and at baseline (consult at least 8 weeks after exacerbation)

• Levels of cytokines in induced sputum

  At the time of the inclusion and at baseline (consult at least 8 weeks after exacerbation)

• Levels of interferons in blood

  At the time of the inclusion and at baseline (consult at least 8 weeks after exacerbation)

Study Arms (2)

Episodic viral wheezers (EVW)

EVW: Wheezing during discrete time periods (exacerbations), absence of symptoms between exacerbations Among which SIW: EVW with ≥ 2 exacerbations over the last 6 months Clinical, microbiological and inflammatory phenotype

Other: Clinical, microbiological and inflammatory phenotype

Multiple trigger wheezers (MTW)

MTW : wheezing during exacerbations but also symptoms between episodes. Clinical, microbiological and inflammatory phenotype

Other: Clinical, microbiological and inflammatory phenotype

Interventions

Clinical, microbiological and inflammatory phenotype OTHER

Clinical phenotype: temporal pattern of wheeze (EVW, SIW, MTW), history and clinical data, allergy diagnosis work-up Microbiological phenotype: viral status (PCR in nasal swab sample), bacteriological status (culture of induced sputum) Inflammatory phenotype: profile of cytokines, phenotype of immune cells in the blood and the sputum, cytokine response to TLR ligands by peripheral blood mononuclear cells.

Episodic viral wheezers (EVW); Multiple trigger wheezers (MTW)

Eligibility Criteria

• Age: 1 Year - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Preschool asthmatic children hospitalized for a severe exacerbation (requiring a course of systemic steroids), in a pediatric ward of one of the hospitals involved in the study, in the Hauts-de-France Region, France.

You may qualify if:

• Preschool children aged 1 to \< 5 years
• Asthmatic / recurrent wheezers (≥ 3 discrete exacerbations since birth and/or symptoms between exacerbations, according to the definition from the French HAS and GINA guidelines)
• Hospitalized (less than 3 days ago) for a severe exacerbation (requiring a course of oral steroids)
• In a pediatric ward participating in the study (Hospital centers of Lille, Arras, Bethune, Douai, Lens, Roubaix, Tourcoing, Armentieres, Seclin)
• Parental consent

You may not qualify if:

• History of chronic disease (other than asthma)
• History of preterm birth (inf 36 weeks of amenorrhea)
• Lack of understanding from the parents

Sponsors & Collaborators

• University Hospital, Lille: lead
• Région Nord-Pas de Calais, France: collaborator
• Stallergenes Greer: collaborator

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole blood, serum, induced sputum, nasal swab sample

MeSH Terms

Conditions

Asthma; Respiratory Sounds

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Antoine Deschildre, MD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2019
• First Posted: May 23, 2019
• Study Start: February 24, 2015
• Primary Completion: April 12, 2023
• Study Completion (Estimated): February 1, 2033
• Last Updated: December 16, 2025

Record last verified: 2025-12