Cohort Analysis of Clinical and Biological Severe Childhood Asthma

NCT02114034 | Active Not Recruiting

• 2 other identifiers: NI12004N° ID RCB: 2012-A00539-34
• Study Type: observational
• Target: 362
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this prospective study is:

• to identify by cluster analysis the main phenotypes of severe asthma and factors involved in the severity,
• to determine the clinical and functional outcomes,
• to identify the factors associated with severe asthma from childhood to adulthood.

Conditions

Severe Asthma

Keywords

Severe asthma,; child,; outcome,

Outcome Measures

Primary Outcomes (1)

• The identification of risk factors for severe asthma

  A prospective follow-up of a cohort of severe pediatric asthma. To improve the identification of risk factors for severe asthma, a group of children with non-severe asthma will also be included

  18 years

Secondary Outcomes (3)

• In the medium and longer term assessment

  4 years

• A short-term assessment

  4 years

• Establish a collection of biological samples (serum bank, DNA Bank, tissue Bank) to search for biomarkers of severity and genetic risk factors for the development of asthma in children.

  18 years

Study Arms (2)

Non-severe asthma

* Children Controlled without treatment or with low doses of inhaled corticosteroids (\<500 mg / day beclometasone equivalent) asthma * and Children with normal EFR * and Children who did not have more severe exacerbation (assessed taking oral corticosteroids) in the previous year * and Children not admitted in the previous year for asthma

Severe asthma

Asthmatic child who, despite treatment with a combination of inhaled corticosteroids (at least 800 mcg / day equivalent Beclomethasone) bronchodilators and long-acting or properly taken daily leukotriene (inhaler technique and compliance verified) presents one of the 3 criteria following: * Persistence of symptoms or chronic use of bronchodilators short duration of action at least three times a week for at least 3 months * exacerbations in the previous year: * at least one care unit admission or continued resuscitation * at least two hospitalizations for acute severe asthma requiring IV therapy * at least 2 courses of oral corticosteroids for exacerbations * post BD FEV \<80% or UARS post BD\> 150% predicted

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Primary Care Clinic

You may qualify if:

• Children with severe asthma:
• Child aged 3 to 12 years
• Asthmatic child who, despite treatment with a combination of inhaled corticosteroids (at least 800 mcg / day equivalent Beclomethasone) bronchodilators and long-acting or properly taken daily leukotriene or short acting nebulized bronchodilators (inhaler technique and compliance verified) presents one of the criteria following:
• Persistence of symptoms or chronic use of bronchodilators short duration of action at least three times a week for at least 3 months
• exacerbations in the previous year:
• at least one care unit admission or continued resuscitation
• at least two hospitalizations for acute severe asthma requiring IV therapy
• at least 2 courses of oral corticosteroids for exacerbations
• post BD FEV \<80% or UARS post BD\> 150% predicted
• Signature of consent or the holder (s) of parental authority
• Particular case of patients treated with Xolair® : Patients currently receiving Xolair® but who met the severity criteria of asthma, as described above, before the start of treatment with Xolair® are includable.
• Children with non-severe asthma:
• Child aged 3 to 12 years
• Controlled without treatment or with low doses of inhaled corticosteroids (\<500 mg / day beclometasone equivalent) asthma
• Child with normal EFR (Child over 4 years)

You may not qualify if:

• Child with bronchopulmonary dysplasia
• Child with severe sequelae of viral infections
• Blood sample for DNA extraction and the biobank: for young children, sampling at least 4 to 5 ml on dry tubes for serum and 6 ml at least for DNA. These samples should be stored at room temperature, transported within 48 hours to biological resources (CRB) Necker E,fa,ts Malades.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

Service de Pneumologie et allergologie pédiatrique, Hôpital Necker-Enfants Malades

Paris, 75015, France

Location

Related Publications (1)

• Lezmi G, Lejeune S, Pin I, Blanchon S, Bouazza N, Jolaine V, Marguet C, Houdoin V, Berger P, Fayon M, Dubus JC, Reix P, Pellan M, Brouard J, Chiron R, Giovannini-Chami L, Deschildre A, de Blic J; COBRAPed Study Group. Factors Associated with Asthma Severity in Children: Data from the French COBRAPed Cohort. J Allergy Clin Immunol Pract. 2021 May;9(5):1969-1979. doi: 10.1016/j.jaip.2020.12.027. Epub 2020 Dec 24.

  PMID: 33359443 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

* whole blood * serum * Bronchoalveolar lavage fluid * bronchial brushing and washing specimens

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Guillaume LEZMI, MD, PhD

  Assistance Publique-Hôpitaux Paris

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 22, 2013
• First Posted: April 15, 2014
• Study Start: November 12, 2013
• Primary Completion (Estimated): November 1, 2032
• Study Completion (Estimated): November 1, 2032
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)