Asthma Clinical Trial
Official title:
Assessment of Utility of Exhaled Nitric Oxide Measurement for Treatment Monitoring in Children With Asthma
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.
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.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic
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