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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00500253

Enrollment

120

Registered

2007-07-12

Start date

2007-02-28

Completion date

2013-12-31

Last updated

2013-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

exhaled nitric oxide, asthma, children, inhaled glucocorticosteroids

Brief summary

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.

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.

Interventions

DEVICEexhaled nitric oxide measurement

exhaled nitric oxide measurement

PROCEDUREbronchial hyperresponsiveness with methacholine (PC20M)

bronchial hyperresponsiveness with methacholine (PC20M)

PROCEDUREsymptom score diary (according to 2007 GINA guidelines)

symptom score diary (according to 2007 GINA guidelines)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

6 Years to 18 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Control of the disease	1 year

Countries

Poland

Contacts

Primary ContactAnna Sołoniewicz, MD

alergol@kopernik.lodz.pl00 48 42 6895972

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026