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

Phase 4

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

• Registration Number: NCT00500253
• Lead Sponsor: Medical University of Lodz

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.

Study Timeline

• Study Start: 2007-02
• Study First Submitted: 2007-07-11
• Study First Submitted QC: 2007-07-11
• Study First Posted: 2007-07-12
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-06
• Last Update Posted: 2013-02-07
• Primary Completion: 2013-11
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

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

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Exclusion Criteria

• presence of other perennial and seasonal allergies
• presence of other chronic diseases
• excluded medications: systemic glucocorticosteroids 3 months before enrollment

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	exhaled nitric oxide measurement	children with asthma with FeNO monitored treatment (study group)
1	bronchial hyperresponsiveness with methacholine (PC20M)	children with asthma with FeNO monitored treatment (study group)
2	bronchial hyperresponsiveness with methacholine (PC20M)	group of children with treatment monitored by GINA's grade of disease clinical control (control group)
2	symptom score diary (according to 2007 GINA guidelines)	group of children with treatment monitored by GINA's grade of disease clinical control (control group)

Primary Outcome Measures

Name	Time	Method
Control of the disease	1 year

Trial Locations

Locations (1)

Department of Pediatrics and Allergy, Medical University of Lodz, Lodz, Poland; 🇵🇱 Lodz, Poland