Exhaled Nitric Oxide and Nasal Lavage Fluid

Study Overview
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Brief Summary
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The allergic respiratory diseases such as asthma or allergic rhinitis are the main chronic diseases in children. The airway inflammation plays an important role in their pathophysiology. Several epidemiological studies show that environmental tobacco smoke (ETS) exacerbates the symptoms of asthma and allergies. The aim of this study is to assess the impact of environmental tobacco smoke on the measurement of exhaled nitric oxide (eNO) and biomarkers of nasal inflammation in atopic asthmatic children.

Detailed Description
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Type of study : This study is a epidemiological observation study type exposed or unexposed to environmental tobacco smoke. Methods : The eNO is determined by a method On-line, at a rate expiratory 50 mL / s, using a chemiluminescence NO analyzer, before the allergy assessment (skin tests and assay of serum total and specific IgE ) and measurement of lung function (spirometry). Nasal lavage is performed by using a validated technique . Cells are counted and differentiated after Giemsa staining. We measured 1-anti-trypsin, neutrophil elastase, albumin, urea, IL4 , IL6, IL8 and IL13. Exposure to ETS is assessed by questionnaire to the parents. Statistical analysis include a narrative strand to verify the normality of distribution and an analytical analysis, including a bivariate followed by a multivariate analysis by multiple linear regression and / or logistic regression to model concentrations of biomarkers of inflammation and adjustment variables such as age, sex, atopic status, eosinophilia and severity of asthma.

Official Title
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Impact of Environmental Tobacco Smoke on Exhaled Nitric Oxide and on Biomarkers of Nasal Inflammation in Atopic Asthmatic Children

Conditions
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Asthma

Intervention / Treatment
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* Device: Measurement of exhaled nitric oxide (eNO)
* Device: Measurement of biomarkers of nasal inflammation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged over 5 years Atopic, persistent mild and moderate Asthmatic Children (GINA 2 and 3) Exclusion Criteria: Child with asthma medication asthma used in the previous 15 days (oral or inhaled corticosteroids, leukotriene antagonist) Recent asthma attack (day of hospitalization or 15 days earlier) Upper respiratory infection (4 weeks) and low (2 weeks) Active smoking (teenager)

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>atopic asthmatic children exposed to environmental tobacco smoke | Device: Measurement of exhaled nitric oxide (eNO)<br>* Chemiluminescence NO analyzer Measurement of lung function (spirometry)<br>Device: Measurement of biomarkers of nasal inflammation<br>* Nasal lavage<br>|
| 2<br>atopic asthmatic children unexposed to environmental tobacco smoke | Device: Measurement of exhaled nitric oxide (eNO)<br>* Chemiluminescence NO analyzer Measurement of lung function (spirometry)<br>Device: Measurement of biomarkers of nasal inflammation<br>* Nasal lavage<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of the impact of environmental tobacco smoke on the measurement of exhaled nitric oxide and the nasal inflammation biomarkers, in atopic asthmatic children aged over 5 years |  | at the inclusion visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the possible association between nasal inflammation (objectified by the determination of biomarkers in the nasal lavage fluid) and bronchial (measurement of exhaled nitric oxide). |  | At the inclusion visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Children, Tobacco smoke exposure, Exhaled nitric oxide, Nasal lavage, Cytokines