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Assessment of Utility of Exhaled Nitric Oxide Measurement for Treatment Monitoring in Children With Asthma
This study is currently recruiting participants.
Verified by Medical Universtity of Lodz, July 2007
Sponsored by: Medical Universtity of Lodz
Information provided by: Medical Universtity of Lodz
ClinicalTrials.gov Identifier: NCT00500253
  Purpose

The aim of this study is to assess the utility of exhaled nitric oxide measurement (FeNO) in treatment monitoring in children with asthma.

According to the aim of the study following assumptions are formulated:

  1. Comparison of annual cumulative steroid dose, number of bronchodilator doses taken, number of asthma exacerbation, number of hospitalisation due to asthma, between group of children with asthma with FeNO monitored treatment (study group), and group of children with treatment monitored by GINA's grade of disease clinical control (control group)
  2. Assessment of corelation of FeNO (ppb) with symptom score (points)and lung function (FEV1)
  3. Comparison of values of non-specific bronchial hyperresponsiveness with methacholine (PC20M)between both study groups after 12. months of treatment.

Condition Intervention Phase
Asthma
Device: exhaled nitric oxide measurement
Procedure: bronchial hyperresponsiveness with methacholine (PC20M)
Procedure: symptom score diary (according to 2007 GINA guidelines)
Phase IV

MedlinePlus related topics: Asthma
Drug Information available for: Nitric oxide Methacholine Methacholine chloride
U.S. FDA Resources
Study Type: Observational
Study Design: Screening, Longitudinal, Defined Population, Prospective Study
Official Title: Assessment of Utility of Exhaled Nitric Oxide Measurement for Treatment Monitoring in Children With Asthma

Further study details as provided by Medical Universtity of Lodz:

Estimated Enrollment: 120
Study Start Date: February 2007
Estimated Study Completion Date: December 2008
Detailed Description:

Asthma is one of the most common chronic disease worldwide, imposing a substantial social burden on both children and adults.

What needs to be kept in mind, especially in assessing treatment effect of allergic inflammation in children with asthma, is that symptom score and spirometry measures have limitations, mainly their subjectivity (symptom scores), wide variability, and lack of stability in short time period (symptom scores and spirometry measures).

Monitoring allergic inflammation in the course of asthma in children with exhaled nitric oxide measurement (FeNO) may allow to titrate the dose of inhaled glucocorticosteroids more precisely, depending on individual patients requirements.

The aim of this study is to assess the utility of FeNO in treatment monitoring in children with asthma.

According to the aim of the study following assumptions are formulated:

  1. Comparison of annual cumulative steroid dose, number of bronchodilator doses taken, number of asthma exacerbation, number of hospitalisation due to asthma, between group of children with asthma with FeNO monitored treatment (study group), and group of children with treatment monitored by GINA's grade of disease clinical control (control group)
  2. Assessment of corelation of FeNO (ppb) with symptom score (points)and lung function (FEV1)
  3. Comparison of values of non-specific bronchial hyperresponsiveness with methacholine (PC20M)between both study groups after 12. months of treatment.
  Eligibility

Ages Eligible for Study:   6 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • FeNO values above the norm for age and inadequate asthma control (based GINA guidelines)

Exclusion Criteria:

  • presence of other perennial and seasonal allergies
  • presence of other chronic diseases
  • excluded medications: systemic glucocorticosteroids 3 months before enrollment
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00500253

Contacts
Contact: Anna Sołoniewicz, MD 00 48 42 6895972 alergol@kopernik.lodz.pl

Locations
Poland
Department of Pediatrics and Allergy, Medical University of Lodz, Lodz, Poland Recruiting
Lodz, Poland, 93-513
Contact: Anna Sołoniewicz, MD     00 48 42 6895972     alergol@kopernik.lodz.pl    
Sub-Investigator: Anna Sołoniewicz, MD            
Principal Investigator: Iwona Stelmach, MD, PhD, Prof            
Sponsors and Collaborators
Medical Universtity of Lodz
Investigators
Principal Investigator: Anna Sołoniewicz, MD Department of Pediatrics and Allergy, Medical University of Lodz, Poland
Study Chair: Iwona Stelmach, MD, PhD, Prof Department of Pediatrics and Allergy, Medical University of Lodz, Poland
  More Information

Study ID Numbers: RNN-56-07-KE
Study First Received: July 11, 2007
Last Updated: July 12, 2007
ClinicalTrials.gov Identifier: NCT00500253  
Health Authority: Poland: Ministry of Health

Keywords provided by Medical Universtity of Lodz:
exhaled nitric oxide
asthma
children
inhaled glucocorticosteroids

Study placed in the following topic categories:
Nitric Oxide
Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases
Methacholine Chloride
Hypersensitivity, Immediate
Asthma
Respiratory Hypersensitivity

Additional relevant MeSH terms:
Parasympathomimetics
Respiratory System Agents
Vasodilator Agents
Neurotransmitter Agents
Antioxidants
Cholinergic Agonists
Bronchial Diseases
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Bronchoconstrictor Agents
Miotics
Physiological Effects of Drugs
Anti-Asthmatic Agents
Cardiovascular Agents
Cholinergic Agents
Protective Agents
Pharmacologic Actions
Autonomic Agents
Therapeutic Uses
Free Radical Scavengers
Muscarinic Agonists
Endothelium-Dependent Relaxing Factors
Peripheral Nervous System Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on January 14, 2009