Exhaled Nitric Oxide and Nasal Lavage Fluid

NCT00773578 | Completed

• 2 other identifiers: P070201AOR05005
• Study Type: observational
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

  at the inclusion visit

Secondary Outcomes (1)

• 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

Study Arms (2)

1

atopic asthmatic children exposed to environmental tobacco smoke

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

2

atopic asthmatic children unexposed to environmental tobacco smoke

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

Interventions

Measurement of exhaled nitric oxide (eNO) DEVICE

Chemiluminescence NO analyzer Measurement of lung function (spirometry)

1; 2

Measurement of biomarkers of nasal inflammation DEVICE

Nasal lavage

1; 2

Eligibility Criteria

• Age: 5 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Aged over 5 years
• Atopic, persistent mild and moderate Asthmatic Children (GINA 2 and 3)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital Trousseau

Paris, 75020, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole blood

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Jocelyne JUST, MdPh

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 15, 2008
• First Posted: October 16, 2008
• Study Start: October 1, 2007
• Primary Completion: September 1, 2008
• Study Completion: February 1, 2009
• Last Updated: February 13, 2009

Record last verified: 2009-02

Locations

FR (1)