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NCT Number: NCT05762627

Severe Eosinophilic Asthma Phenotypes During Childhood Have Various Origins

Study of the clinical evolution at 10 years of children from the SAMP cohort (severe asthma, eosinophilic or not, allergic or not) in order to understand the different possible evolutions of these phenotypes at different ages.

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Key information

About this study

Multiple sensitizations but also blood eosinophilia are associated with the persistence of exacerbations during childhood. The pivotal role of eosinophilia in the pathophysiology of allergic asthma and more generally of severe asthma in the pediatric population has made it an important research topic for many years. The indirect demonstration of bronchial inflammation by analyzing blood eosinophilia is common practice, especially when monitoring the effectiveness of biotherapies. However, blood eosinophilia is not always clearly related to bronchial eosinophilia.

On the other hand, several teams have recently sought to highlight the recurrence of allergen sensitization profiles associated with severe asthma, in order to identify predictive factors of clinical evolution.

Finally, recent studies have shown that the nasal microbiota plays an important role in the onset, development and severity of asthma.

Our study will allow us to study the clinical evolution at 10 years of the children from the SAMP cohort (severe asthma, eosinophilic or not, allergic or not) in order to understand the different possible evolutions of these phenotypes at different ages. These phenotypic trajectories have an important therapeutic implication, leading to the prescription of personalized treatments, in particular biologics (monoclonal antibodies).

Primary objective To evaluate, in children with moderate to severe asthma, the control of asthma according to the therapeutic load, atopic pathologies during childhood and initial serum levels of blood eosinophils and biomarkers of eosinophil activation Secondary objective Evaluate the evolution of asthma phenotypes according to the associated atopic pathologies (allergic rhinitis, atopic dermatitis and food allergy), according to the number of atopic comorbidities and their severity.

Study of the microbiota in children followed for moderate to severe asthma.

Practical procedure The investigator record the new tests prescribed as part of the routine care of these patients (respiratory function tests, blood tests) and ask them to complete a questionnaire (no travel required specifically for the study). In the event of a blood test prescribed and carried out in the department, the investigator will take an additional 2 ml, and perform a nasal and skin swab.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • absence of opposition from the legal representative of the patient and if possible from the patient himself.
  • patient with moderate to severe asthma at preschool or school age, previously included in SAMP Cohort

Exclusion criteria

  • Patient included in another clinical study.
  • Lack of coverage by social security.

Treatment and study plan

Primary outcomes

  1. asthma control 1

    Time frame: through study completion, 4 years

    Asthma control according to GINA (Global Initiative for Asthma. Global Strategy for Asthma Management and Prevention, 2020. www.ginasthma.org.)

  2. asthma control 2

    Time frame: through study completion, 4 years

    Score of the Asthma Control Test (for children > 11 years old) and of the Asthma Control Test reserved for asthmatic children from 4 to 11 years old (ACT™, © 2002, by QualityMetric Incorporated Asthma France / French Control Test™ is a trademark of QualityMetric Incorporated. www.asthmacontroltest.com)

Secondary outcomes

  1. asthma severity 1

    Time frame: through study completion, 4 years

    Asthma severity according to GINA (Global Initiative for Asthma. Global Strategy for Asthma Management and Prevention, 2022. www.ginasthma.org.)

  2. asthma severity 2

    Time frame: through study completion, 4 years

    Respiratory function tests (spirometry and plethysmography)

  3. atopic comorbidities 1

    Time frame: through study completion, 4 years

    Rhinitis control score: ARIA score (Allergic Rhinitis and its Impact on Asthma) endorsed by the WHO (Bousquet J, van Cauwenberge P, Khaltaev N, and the WHO panel members: Allergic Rhinitis and Its Impact on Asthma. ARIA. In collaboration with the World Health Organization. J Allergy Clin Immunol 2001; 108: S1-S315)

  4. atopic comorbidities 2

    Time frame: through study completion, 4 years

    Eczema control score: SCORAD score (Scoring atopic dermatitis) (Dermatology 1993; n°186 p23-p31. European Task Force of Atopic Dermatitis)

  5. atopic comorbidities 3

    Time frame: through study completion, 4 years

    Food allergy

  6. nasal and skin microbiota

    Time frame: 1 day at inclusion of patient

    nasal and skin swabs for research of colonization with staphylococcus aureus

Study contacts

Contact information is provided by the study sponsor or research team.

Jocelyne Just, MD, PhD

CONTACT

[email protected]

+33 (0) 1-44-73-74-75

Mélisande Bourgoin-Heck, MD, MSc

CONTACT

[email protected]

+33 (0)1-71-73-87-46

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

Trajectories of Severe Eosinophilic Asthma During Childhood: Experience of the SAMP (Severe Asthma Molecular Phenotype) Cohort

Acronym: SAMP 2

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Mar 9, 2023
Registry last updated
Mar 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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