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Exhaled Nitric Oxide and Nasal Lavage Fluid

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00773578
Acronym
NOLN
Enrollment
49
Registered
2008-10-16
Start date
2007-10-31
Completion date
2009-02-28
Last updated
2009-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

Children, Tobacco smoke exposure, Exhaled nitric oxide, Nasal lavage, Cytokines

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.

Interventions

DEVICEMeasurement of exhaled nitric oxide (eNO)

Chemiluminescence NO analyzer Measurement of lung function (spirometry)

DEVICEMeasurement of biomarkers of nasal inflammation

Nasal lavage

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
5 Years to 16 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime 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 yearsat the inclusion visit

Secondary

MeasureTime 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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026