Cohort Analysis of Clinical and Biological Severe Childhood Asthma

NCT ID: NCT02114034

Last Updated: 2025-09-15

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 362 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-11-12
• Study Completion Date: 2032-11-30

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.

Detailed Description

Severe asthma involves about 5 % of asthmatic children and is associated with a high impact on hospitalizations, absenteeism and quality of life.

Although our knowledge has progressed in a substantial way during the last ten years, a number of unresolved questions persist in particular as regard to the contributing factors and outcomes from early childhood to adulthood.

After parental agreement the following elements will be collected at inclusion: clinical environmental data, pulmonary function, allergy test data (skin prick tests and specific IgE), blood and serum samples for biobank (DNA / SERUM). In a restricted number of children a more extensive work up will be performed which may include flexible bronchoscopy, bronchial brushing and bronchoalveolar lavage.

The follow-up will be performed every 6 months within the framework of the usual care including collection of clinical data and pulmonary function tests. The allergic status will be done again at 6-7 years, 12 years and 18 years.

In the group of children having non-severe asthma, the follow-up will be annual with collection of clinical data and pulmonary function tests.

Conditions

Severe Asthma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

No interventions assigned to this group

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

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

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)
• Child who did not have more severe exacerbation (assessed taking oral corticosteroids) in the previous year
• Child not admitted in the previous year for asthma.
• Signature of consent or the holder (s) of parental authority

Exclusion Criteria

• Child with bronchopulmonary dysplasia
• Child with severe sequelae of viral infections
• Refusal of the child or parents Data collection for research and follow up of patients : tests carried out in the 3 months prior to inclusion are used

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.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

URC-CIC Paris Descartes Necker Cochin

OTHER

Sponsor Role: collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Guillaume LEZMI, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique-Hôpitaux Paris

Locations

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

Paris, , France

Countries

France

References

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.

Reference Type: BACKGROUND

PMID: 33359443 (View on PubMed)

Other Identifiers

N° ID RCB: 2012-A00539-34

Identifier Type: -

Identifier Source: secondary_id

NI12004

Identifier Type: -

Identifier Source: org_study_id