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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Medical Universtity of Lodz
Sponsor:
Information provided by (Responsible Party):
Iwona Stelmach, Medical Universtity of Lodz
ClinicalTrials.gov Identifier:
NCT00500253
First received: July 11, 2007
Last updated: February 6, 2013
Last verified: February 2013
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic
Official Title: Assessment of Utility of Exhaled Nitric Oxide Measurement for Treatment Monitoring in Children With Asthma

Resource links provided by NLM:


Further study details as provided by Medical Universtity of Lodz:

Primary Outcome Measures:
  • Control of the disease [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: February 2007
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)
Other Name: symptom score diary (according to 2007 GINA guidelines)

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.
  Eligibility

Ages Eligible for Study:   6 Years to 18 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: July 11, 2007
Last Updated: February 6, 2013
Health Authority: Poland: Ministry of Health

Keywords provided by 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
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Cardiovascular Agents
Protective Agents
Miotics
Parasympathomimetics
Bronchoconstrictor Agents

ClinicalTrials.gov processed this record on July 26, 2014