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Clinical Trials/NCT02038374
NCT02038374
Unknown
Not Applicable

Clinico-biological Correlation of Severe Asthma in Children

Assistance Publique Hopitaux De Marseille1 site in 1 country40 target enrollmentNovember 2013
ConditionsSevere Asthma

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Severe Asthma
Sponsor
Assistance Publique Hopitaux De Marseille
Enrollment
40
Locations
1
Primary Endpoint
analysis of bronchial biopsies
Last Updated
11 years ago

Overview

Brief Summary

Asthma is the most common chronic respiratory disorder in children. Despite significant advances in understanding of asthma, available therapies fail to alter the natural history and progression of the disease. Airway epithelial cells are continuously exposed to and injured by environmental irritants, such as viruses and pollutants, and as such are ideally situated to orchestrate airway function in response to these stimuli.

Severe or difficult-to-treat asthma in children is a complicated disorder characterized by ongoing symptoms and persistent airway inflammation and oxidant stress despite corticosteroid treatment. Although severe asthma is likely a heterogeneous disorder, affected children similar clinical features, including gas trapping, bronchial hyperresponsiveness, and aeroallergen sensitization. However, the molecular and cellular pattern of inflammation in children with severe asthma are not uniform : some investigators have found increased eosinophils and TH2 derived cytokines, others have noted noneosinophilic patterns with neutrophil activation.

Given the heterogeneity of the inflammatory response in children with severe asthma, additional methods to distinguish severe asthma are needed.

Registry
clinicaltrials.gov
Start Date
November 2013
End Date
April 2015
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Children 0-18 years
  • patients followed regularly for at least one year.
  • The diagnosis of asthma is increased according to the criteria of the Global Initiative for Asthma (GINA): children with a history of recurrent episodes of bronchial obstruction.
  • children with severe asthma defined by the American Thoracic Society (ATS): Severe asthma is defined by the presence of a major criterion: the need for high doses of inhaled corticosteroids (budesonide dose equivalent 400 micro g) and least two of the five minor criteria:
  • The daily use of beta 2 long-acting or short-term daily action (\<4 years) or anti-leukotrienes associated with inhaled corticosteroids Daily or almost daily use of beta-2 short-acting Permanent-bronchial obstruction (FEV \<80% predicted FEV)
  • At least one emergency department visit for asthma exacerbations in France
  • At least 3 courses of oral corticosteroids per year

Exclusion Criteria

  • parents' refusal to participate in the study
  • refusal children to participate pathology underlying cardiac, neuromuscular, immunodeficiency

Outcomes

Primary Outcomes

analysis of bronchial biopsies

Time Frame: 12 months

Number of ciliated cells(units) versus cells(units) with mucus found by fields of interface of the culture

Study Sites (1)

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