Assessment of Utility of Exhaled Nitric Oxide Measurement for Treatment Monitoring in Children With Asthma

Study Overview
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Brief Summary
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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: 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) Assessment of corelation of FeNO (ppb) with symptom score (points)and lung function (FEV1) Comparison of values of non-specific bronchial hyperresponsiveness with methacholine (PC20M)between both study groups after 12. months of treatment.

Detailed Description
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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: 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) Assessment of corelation of FeNO (ppb) with symptom score (points)and lung function (FEV1) Comparison of values of non-specific bronchial hyperresponsiveness with methacholine (PC20M)between both study groups after 12. months of treatment.

Official Title
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Assessment of Utility of Exhaled Nitric Oxide Measurement for Treatment Monitoring in Children With Asthma

Conditions
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Asthma

Intervention / Treatment
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* Device: exhaled nitric oxide measurement
* Procedure: bronchial hyperresponsiveness with methacholine (PC20M)
* Procedure: symptom score diary (according to 2007 GINA guidelines)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>children with asthma with FeNO monitored treatment (study group) | Device: exhaled nitric oxide measurement<br>* exhaled nitric oxide measurement<br>* Other names: exhaled nitric oxide measurement (Sievers FeNO analyzer);Procedure: bronchial hyperresponsiveness with methacholine (PC20M)<br>* bronchial hyperresponsiveness with methacholine (PC20M)<br>* Other names: PC20M Jaeger APS system;|
| Other: 2<br>group of children with treatment monitored by GINA's grade of disease clinical control (control group) | Procedure: bronchial hyperresponsiveness with methacholine (PC20M)<br>* bronchial hyperresponsiveness with methacholine (PC20M)<br>* Other names: PC20M Jaeger APS system;Procedure: symptom score diary (according to 2007 GINA guidelines)<br>* symptom score diary (according to 2007 GINA guidelines)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Control of the disease |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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exhaled nitric oxide, asthma, children, inhaled glucocorticosteroids