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

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Asthma	Device: exhaled nitric oxide measurement; Procedure: bronchial hyperresponsiveness with methacholine (PC20M); Procedure: symptom score diary (according to 2007 GINA guidelines)	Phase 4

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 Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	120 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Participant)
Primary Purpose:	Diagnostic
Official Title:	Assessment of Utility of Exhaled Nitric Oxide Measurement for Treatment Monitoring in Children With Asthma
Study Start Date :	February 2007
Estimated Primary Completion Date :	November 2013
Estimated Study Completion Date :	December 2013

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures

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Primary Outcome Measures :

1. Control of the disease [ Time Frame: 1 year ]

Eligibility Criteria

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Ages Eligible for Study:	6 Years to 18 Years (Child, Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Anna Sołoniewicz, MD	00 48 42 6895972	alergol@kopernik.lodz.pl

Locations

Poland
Department of Pediatrics and Allergy, Medical University of Lodz, Lodz, Poland	Recruiting
Lodz, Poland, 93-513
Contact: Anna Sołoniewicz, MD 00 48 42 6895972 alergol@kopernik.lodz.pl
Sub-Investigator: Anna Sołoniewicz, MD
Principal Investigator: Iwona Stelmach, MD, PhD, Prof

Sponsors and Collaborators

Medical Universtity of Lodz

Investigators

Principal Investigator:	Anna Sołoniewicz, MD	Department of Pediatrics and Allergy, Medical University of Lodz, Poland
Study Chair:	Iwona Stelmach, MD, PhD, Prof	Department of Pediatrics and Allergy, Medical University of Lodz, Poland

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Iwona Stelmach, MD, PhD, Professor, Medical Universtity of Lodz
ClinicalTrials.gov Identifier:	NCT00500253 History of Changes
Other Study ID Numbers:	RNN-56-07-KE
First Posted:	July 12, 2007
Last Update Posted:	February 7, 2013
Last Verified:	February 2013

Keywords provided by Iwona Stelmach, Medical Universtity of Lodz:

exhaled nitric oxide; asthma; children; inhaled glucocorticosteroids

Additional relevant MeSH terms:

Asthma; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Nitric Oxide; Methacholine Chloride; Bronchodilator Agents; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs	Anti-Asthmatic Agents; Respiratory System Agents; Free Radical Scavengers; Antioxidants; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Agents; Endothelium-Dependent Relaxing Factors; Vasodilator Agents; Gasotransmitters; Protective Agents; Miotics; Parasympathomimetics; Bronchoconstrictor Agents; Muscarinic Agonists; Cholinergic Agonists