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

July 11, 2007
February 6, 2013
February 2007
November 2013   (final data collection date for primary outcome measure)
Control of the disease [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00500253 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Assessment of Utility of Exhaled Nitric Oxide Measurement for Treatment Monitoring in Children With Asthma
Assessment of Utility of Exhaled Nitric Oxide Measurement for Treatment Monitoring in Children With Asthma

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.

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.
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic
Asthma
  • 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
  • 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)
  • Active Comparator: 1
    children with asthma with FeNO monitored treatment (study group)
    Interventions:
    • Device: exhaled nitric oxide measurement
    • Procedure: bronchial hyperresponsiveness with methacholine (PC20M)
  • 2
    group of children with treatment monitored by GINA's grade of disease clinical control (control group)
    Interventions:
    • Procedure: bronchial hyperresponsiveness with methacholine (PC20M)
    • Procedure: symptom score diary (according to 2007 GINA guidelines)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
December 2013
November 2013   (final data collection date for primary outcome measure)

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
Both
6 Years to 18 Years
No
Contact: Anna Sołoniewicz, MD 00 48 42 6895972 alergol@kopernik.lodz.pl
Poland
 
NCT00500253
RNN-56-07-KE
Yes
Iwona Stelmach, Medical Universtity of Lodz
Medical Universtity of Lodz
Not Provided
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
Medical Universtity of Lodz
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP