Exhaled Nitric Oxide and Nasal Lavage Fluid (NOLN)

This study has been completed.
Sponsor:
Information provided by:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00773578
First received: October 15, 2008
Last updated: February 12, 2009
Last verified: February 2009
  Purpose

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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Impact of Environmental Tobacco Smoke on Exhaled Nitric Oxide and on Biomarkers of Nasal Inflammation in Atopic Asthmatic Children

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • 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 [ Time Frame: at the inclusion visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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). [ Time Frame: At the inclusion visit ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Whole blood


Enrollment: 49
Study Start Date: October 2007
Study Completion Date: February 2009
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
atopic asthmatic children exposed to environmental tobacco smoke
Device: Measurement of exhaled nitric oxide (eNO)
Chemiluminescence NO analyzer Measurement of lung function (spirometry)
Other Name: Measurement of exhaled nitric oxide (eNO)
Device: Measurement of biomarkers of nasal inflammation
Nasal lavage
Other Name: Measurement of biomarkers of nasal inflammation
2
atopic asthmatic children unexposed to environmental tobacco smoke
Device: Measurement of exhaled nitric oxide (eNO)
Chemiluminescence NO analyzer Measurement of lung function (spirometry)
Other Name: Measurement of exhaled nitric oxide (eNO)
Device: Measurement of biomarkers of nasal inflammation
Nasal lavage
Other Name: Measurement of biomarkers of nasal inflammation

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.

  Eligibility

Ages Eligible for Study:   5 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Atopic asthmatic children followed in the Asthma Center, Trousseau Hospital, Paris

Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00773578

Locations
France
Hôpital Trousseau
Paris, France, 75020
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Jocelyne JUST, MdPh Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Yannick Vacher, Department Clinical Research of Developpement
ClinicalTrials.gov Identifier: NCT00773578     History of Changes
Other Study ID Numbers: P070201, AOR05005
Study First Received: October 15, 2008
Last Updated: February 12, 2009
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Children
Tobacco smoke exposure
Exhaled nitric oxide
Nasal lavage
Cytokines

Additional relevant MeSH terms:
Nitric Oxide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Cardiovascular Agents
Gasotransmitters
Protective Agents

ClinicalTrials.gov processed this record on September 18, 2014