Exhaled Nitric Oxide and Nasal Lavage Fluid

Asthma Clinical Trial

— NOLN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00773578
• Other study ID #: P070201
• Secondary ID: AOR05005
• Status: Completed
• Phase: N/A
• First received: October 15, 2008
• Last updated: February 12, 2009
• Start date: October 2007
• Est. completion date: February 2009

Study information

• Verified date: February 2009
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: February 2009
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 16 Years

Eligibility

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)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Asthma

Intervention

Device:
• Measurement of exhaled nitric oxide (eNO)
Chemiluminescence NO analyzer Measurement of lung function (spirometry)
• Measurement of biomarkers of nasal inflammation
Nasal lavage

Locations

Country	Name	City	State
France	Hôpital Trousseau	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No