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

Medical University of Lodz

Status and phase: Unknown; Phase 4

Conditions: Asthma

Treatments: Device: exhaled nitric oxide measurement; Procedure: bronchial hyperresponsiveness with methacholine (PC20M); Procedure: symptom score diary (according to 2007 GINA guidelines)

Study type: Interventional

Funder types: Other

Identifiers

NCT00500253

RNN-56-07-KE

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 6 to 18 years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

1

Active Comparator group

Description:

children with asthma with FeNO monitored treatment (study group)

Treatment:

Procedure: bronchial hyperresponsiveness with methacholine (PC20M)

Device: exhaled nitric oxide measurement

2

Other group

Description:

group of children with treatment monitored by GINA's grade of disease clinical control (control group)

Treatment:

Procedure: symptom score diary (according to 2007 GINA guidelines)

Procedure: bronchial hyperresponsiveness with methacholine (PC20M)