NCT03960359|Active Not Recruiting
Inflammatory and Immune Profiles During a Severe Exacerbation in Preschool Asthmatic Children (<5 Years)
VIRASTHMA2
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VIRASTHMA2
Sponsor study identifier
Secondary identifiers
OTHER · ID-RCB number, ANSM
observational
150
0 countries
N/A
Study Start
February 24, 2015
Actual (reported)Primary Completion
April 12, 2023
Actual (reported)Study Completion
February 2033
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 2033
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 24, 2015
Actual (reported)January 17, 2019
Actual (reported)May 23, 2019
Actual (reported)April 12, 2023
Actual (reported)February 2033
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
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)
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
MTW : wheezing during exacerbations but also symptoms between episodes. Clinical, microbiological and inflammatory phenotype
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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.
Whole blood, serum, induced sputum, nasal swab sample
Antoine Deschildre, MD
University Hospital, Lille
First Submitted
January 17, 2019
First Posted
May 23, 2019
Study Start
February 24, 2015
Actual (reported)Primary Completion
April 12, 2023
Actual (reported)Safety of Nasal Influenza Immunisation in Children With Asthma
Contact the study team to confirm eligibility.
Study Completion
February 2033
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
December 16, 2025
Record last verified: 2025-12
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