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Is the Exhaled Nitric Oxide in Infants a Predictive Marker of Asthma ? (NOnourisson)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01239199
First received: October 21, 2010
Last updated: July 25, 2012
Last verified: June 2012
History of Changes
  Purpose

Background:

It seems that in the infants and the young children, the increase of the Exhaled Nitric Oxide (eNO) is in connection with: (1) the risk of developing respiratory symptoms; (2) the risk of family and personal atopy; (3) the intensity of the respiratory symptoms; (4) the risk of passage of recurrent wheezing to asthma; (5) and contrary to the fact that the investigators noticed at the child's a positive relation with the environmental tobacco smoke

Objective: the investigators objective is to bring to light that the rise of the eNO, a non invasive biomarker of the bronchial inflammation, would be a risk factor expected from passage of recurrent wheezing of the infant and the young child (of less than 36 months old) towards the asthma of the child.Methods: Once the diagnosis of recurrent wheezing established, the investigators estimate by questionnaire the severity of the asthma, the personal and familial atopy, the collection of the environmental data. After allergic exploration (skin tests and assay of serum total and specific IgE, complete blood count), the eNO is measured by an off-line tidal breathing method using a chemiluminescence NO analyzer. Annually, a questionnaire will be send to families to appreciate the persistence or the remission of the asthma. After a simple descriptive analysis of the population and a multifactorial descriptive analysis, the investigators shall look for the connections between the rise of the eNO and the various clinical, biological and environmental parameters known to influence the variations of this marker. Then the investigators shall select a set of explanatory variables for a multivariate analysis by a logistic regression step by step.


Condition Intervention
Asthma
 Other: Measure of the exhaled NO

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Is the Exhaled Nitric Oxide in Infants a Predictive Marker of Asthma?

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Measure of exhaled nitric oxide at the beginning of the study and incidence of asthma symptoms after 3 years of follow up [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Atopic status with total and specific IgE levels and skin test, complete blood count [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Estimated Enrollment: 264
Study Start Date: January 2010
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Exhaled NO Other: Measure of the exhaled NO
The exhaled NO will be measure by chemiluminescence in current ventilation by an indirect method (off-line)

Detailed Description:

This study is a epidemiological observation study

  Eligibility

Ages Eligible for Study:   6 Months to 36 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Infant between 6 and 36 months
  • More than 3 wheezing episodes
  • Questionary and biological assessment for recurrent wheeze
  • Signature of the consent by 2 parents or by the only one of 2 parents (if this last one is the only present in the inclusion of the child)

Exclusion Criteria:

  • Infant with respiratory disease in neonatal period
  • Infant with other obstructive pathology (cystic fibrosis, Primary Ciliary Dyskinesia,…)
  • Infant who have a respiratory infection less than 4 weeks
  • Infant with asthma exacerbation or who still have corticosteroid treatment
  • Infant without social security from their parents
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01239199

Locations
France
Service of multidisciplinary paediatrics (Armand-Trousseau Hospital)
Paris, Ile de France, France, 75012
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Jocelyne Just Trousseau Hospital - APHP
  More Information

Publications:

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01239199     History of Changes
Other Study ID Numbers: P 070802
Study First Received: October 21, 2010
Last Updated: July 25, 2012
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Infants
Exhaled Nitric Oxide
Asthma
Tobacco smoke exposure
environment

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
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
Protective Agents

ClinicalTrials.gov processed this record on May 16, 2013