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

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ClinicalTrials.gov Identifier: NCT00500253
Recruitment Status : Unknown
Verified February 2013 by Iwona Stelmach, Medical Universtity of Lodz.
Recruitment status was:  Recruiting
First Posted : July 12, 2007
Last Update Posted : February 7, 2013
Sponsor:
Information provided by (Responsible Party):
Iwona Stelmach, Medical Universtity of Lodz

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

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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
U.S. FDA Resources

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00500253


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    Key Record Dates
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