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| ID | Type | Description | Link |
|---|---|---|---|
| N° ID RCB: 2012-A00539-34 |
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| Name | Class |
|---|---|
| URC-CIC Paris Descartes Necker Cochin | OTHER |
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The purpose of this prospective study is:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-severe 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:
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| In the medium and longer term assessment |
| 4 years |
| A short-term assessment |
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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:
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:
Inclusion Criteria
Exclusion Criteria:
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.
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Primary Care Clinic
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| Name | Affiliation | Role |
|---|---|---|
| Guillaume LEZMI, MD, PhD | Assistance Publique-Hôpitaux Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service de Pneumologie et allergologie pédiatrique, Hôpital Necker-Enfants Malades | Paris | 75015 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33359443 | Result | 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. |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| 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 |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |