ClinicalTrials.Veeva

Menu

Exhaled Nitric Oxide and Nasal Lavage Fluid (NOLN)

A

Assistance Publique - Hôpitaux de Paris

Status

Completed

Conditions

Asthma

Treatments

Device: Measurement of exhaled nitric oxide (eNO)
Device: Measurement of biomarkers of nasal inflammation

Study type

Observational

Funder types

Other

Identifiers

NCT00773578
AOR05005
P070201

Details and patient eligibility

About

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.

Full 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.

Enrollment

49 patients

Sex

All

Ages

5 to 16 years old

Volunteers

No Healthy Volunteers

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)

Trial design

49 participants in 2 patient groups

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

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems