Exhaled Nitric Oxide and Nasal Lavage Fluid

Completed

• Conditions: Asthma
• Interventions: Device: Measurement of exhaled nitric oxide (eNO); Device: Measurement of biomarkers of nasal inflammation

• Registration Number: NCT00773578
• Lead Sponsor: Assistance Publique - Hôpitaux de 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.

Study Timeline

• Study Start: 2007-10
• Primary Completion: 2008-09
• Study First Submitted: 2008-10-15
• Study First Submitted QC: 2008-10-15
• Study First Posted: 2008-10-16
• Status Verified: 2009-02
• Study Completion: 2009-02
• Last Update Submitted: 2009-02-12
• Last Update Posted: 2009-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

Inclusion Criteria

• Aged over 5 years
• Atopic, persistent mild and moderate Asthmatic Children (GINA 2 and 3)

Read More

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)

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
2	Measurement of exhaled nitric oxide (eNO)	atopic asthmatic children unexposed to environmental tobacco smoke
1	Measurement of exhaled nitric oxide (eNO)	atopic asthmatic children exposed to environmental tobacco smoke
1	Measurement of biomarkers of nasal inflammation	atopic asthmatic children exposed to environmental tobacco smoke
2	Measurement of biomarkers of nasal inflammation	atopic asthmatic children unexposed to environmental tobacco smoke

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Hôpital Trousseau; 🇫🇷 Paris, France