Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
49 participants
OBSERVATIONAL
2007-10-31
2009-02-28
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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1
atopic asthmatic children exposed to environmental tobacco smoke
Measurement of exhaled nitric oxide (eNO)
Chemiluminescence NO analyzer Measurement of lung function (spirometry)
Measurement of biomarkers of nasal inflammation
Nasal lavage
2
atopic asthmatic children unexposed to environmental tobacco smoke
Measurement of exhaled nitric oxide (eNO)
Chemiluminescence NO analyzer Measurement of lung function (spirometry)
Measurement of biomarkers of nasal inflammation
Nasal lavage
Interventions
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Measurement of exhaled nitric oxide (eNO)
Chemiluminescence NO analyzer Measurement of lung function (spirometry)
Measurement of biomarkers of nasal inflammation
Nasal lavage
Eligibility Criteria
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Inclusion Criteria
* Atopic, persistent mild and moderate Asthmatic Children (GINA 2 and 3)
Exclusion Criteria
* Recent asthma attack (day of hospitalization or 15 days earlier)
* Upper respiratory infection (4 weeks) and low (2 weeks)
* Active smoking (teenager)
5 Years
16 Years
ALL
No
Sponsors
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Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Department Clinical Research of Developpement
Principal Investigators
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Jocelyne JUST, MdPh
Role: PRINCIPAL_INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Locations
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Hôpital Trousseau
Paris, , France
Countries
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Other Identifiers
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AOR05005
Identifier Type: -
Identifier Source: secondary_id
P070201
Identifier Type: -
Identifier Source: org_study_id
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