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Sponsored by: |
Assistance Publique - Hôpitaux de Paris |
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Information provided by: | Assistance Publique - Hôpitaux de Paris |
ClinicalTrials.gov Identifier: | NCT00773578 |
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.
Condition | Intervention |
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Asthma |
Device: Measurement of exhaled nitric oxide (eNO) Device: Measurement of biomarkers of nasal inflammation |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | Impact of Environmental Tobacco Smoke on Exhaled Nitric Oxide and on Biomarkers of Nasal Inflammation in Atopic Asthmatic Children |
Whole blood
Enrollment: | 49 |
Study Start Date: | October 2007 |
Study Completion Date: | October 2008 |
Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
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1
atopic asthmatic children exposed to environmental tobacco smoke
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Device: Measurement of exhaled nitric oxide (eNO)
Chemiluminescence NO analyzer Measurement of lung function (spirometry)
Device: Measurement of biomarkers of nasal inflammation
Nasal lavage
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2
atopic asthmatic children unexposed to environmental tobacco smoke
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Device: Measurement of exhaled nitric oxide (eNO)
Chemiluminescence NO analyzer Measurement of lung function (spirometry)
Device: Measurement of biomarkers of nasal inflammation
Nasal lavage
|
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.
Ages Eligible for Study: | 5 Years to 16 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Atopic asthmatic children followed in the Asthma Center, Trousseau Hospital, Paris
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Department Clinical Research of Developpement ( Yannick Vacher ) |
Study ID Numbers: | P070201, AOR05005 |
Study First Received: | October 15, 2008 |
Last Updated: | October 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00773578 |
Health Authority: | France: Ministry of Health |
Children Tobacco smoke exposure Exhaled nitric oxide Nasal lavage Cytokines |
Nitric Oxide Smoking Asthma Inflammation |
Respiratory System Agents Vasodilator Agents Neurotransmitter Agents Antioxidants Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Anti-Asthmatic Agents Cardiovascular Agents |
Protective Agents Pharmacologic Actions Autonomic Agents Therapeutic Uses Free Radical Scavengers Endothelium-Dependent Relaxing Factors Peripheral Nervous System Agents Bronchodilator Agents |