Clinical trial NCT00773578: Exhaled Nitric Oxide and Nasal Lavage Fluid
Official title: Impact of Environmental Tobacco Smoke on Exhaled Nitric Oxide and on Biomarkers of Nasal Inflammation in Atopic Asthmatic Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Keywords: Children
Tobacco smoke exposure
Exhaled nitric oxide
Nasal lavage
Cytokines
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2008-10-16
Enrollment: 49
Sex: ALL
Minimum age (years): 5
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Atopic asthmatic children followed in the Asthma Center, Trousseau Hospital, Paris

Brief summary: 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: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: 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
timeFrame: at the inclusion visit
Secondary outcomes:
measure: 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).
timeFrame: At the inclusion visit
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Trousseau
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Jocelyne JUST, MdPh
role: PRINCIPAL_INVESTIGATOR
References: