Severe Eosinophilic Asthma Phenotypes During Childhood Have Various Origins

NCT05762627 | Not Yet Recruiting

• 1 other identifier: APHP220980
• Study Type: observational
• Target: 360
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Severe Asthma; Asthma in Children

Keywords

Childhood severe asthma; Eosinophilic asthma; Allergic asthma; Asthma trajectories; Type 2 inflammation

Outcome Measures

Primary Outcomes (2)

• asthma control 1

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

  through study completion, 4 years

• asthma control 2

  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)

  through study completion, 4 years

Secondary Outcomes (6)

• asthma severity 1

  through study completion, 4 years

• asthma severity 2

  through study completion, 4 years

• atopic comorbidities 1

  through study completion, 4 years

• atopic comorbidities 2

  through study completion, 4 years

• atopic comorbidities 3

  through study completion, 4 years

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients from SAMP cohort

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Allergy Department, Trousseau Hospital

Paris, 75012, France

Location

MeSH Terms

Conditions

Asthma; Pulmonary Eosinophilia

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Hypereosinophilic Syndrome; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Mélisande Bourgoin-Heck, MD, MSc

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mélisande Bourgoin-Heck, MD, MSc

CONTACT

+33 (0)1-71-73-87-46; Melisande.bourgoin-heck@aphp.fr

Jocelyne Just, MD, PhD

CONTACT

+33 (0) 1-44-73-74-75; jocelyne.just@inserm.fr

Study Design

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

Study Record Dates

• First Submitted: December 7, 2022
• First Posted: March 9, 2023
• Study Start: March 1, 2023
• Primary Completion: March 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: March 9, 2023

Record last verified: 2023-02

Locations

FR (1)