NCT03960359Active, not recruiting
Inflammatory and Immune Profiles During a Severe Exacerbation in Preschool Asthmatic Children (<5 Years)
Inflammatory and Immune Profiles at the Time of a Severe Exacerbation in Preschool Asthmatic Children (<5 Years), According to the Phenotype
Source: ClinicalTrials.gov · Last updated 16 Dec 2025
Brief summary (registry, in English)
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
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 150 (estimated)
- First submitted
- 17 Jan 2019
- Start date
- 24 Feb 2015
- Primary completion date
- 12 Apr 2023
- Lead sponsor
- University Hospital, Lille
- Diseases
- Asthma
- NCT number
- NCT03960359
What you commit to
- Study type: Observational
- Planned participants: 150
- From 24 Feb 2015 to the primary completion date, 12 Apr 2023
- No sites listed in no 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.
Other illness
- History of chronic disease (other than asthma)
- History of preterm birth (inf 36 weeks of amenorrhea)
Other
- Lack of understanding from the parents
Who the study is looking for
- 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
Age in the registry: 1 year to 5 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.