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

February 6, 2013 updated by: Iwona Stelmach, Medical University of Lodz

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.

Study Overview

Status

Unknown

Conditions

Intervention / 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 Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Lodz, Poland, 93-513
        • Recruiting
        • Department of Pediatrics and Allergy, Medical University of Lodz, Lodz, Poland
        • Principal Investigator:
          • Iwona Stelmach, MD, PhD, Prof
        • Contact:
        • Sub-Investigator:
          • Anna Sołoniewicz, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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 Names:
  • exhaled nitric oxide measurement (Sievers FeNO analyzer)
Procedure: bronchial hyperresponsiveness with methacholine (PC20M)
bronchial hyperresponsiveness with methacholine (PC20M)
Other Names:
  • PC20M Jaeger APS system
Other: 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 Names:
  • PC20M Jaeger APS system
Procedure: symptom score diary (according to 2007 GINA guidelines)
symptom score diary (according to 2007 GINA guidelines)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Control of the disease
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Lodz

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Primary Completion (Anticipated)

November 1, 2013

Study Completion (Anticipated)

December 1, 2013

Study Registration Dates

First Submitted

July 11, 2007

First Submitted That Met QC Criteria

July 11, 2007

First Posted (Estimate)

July 12, 2007

Study Record Updates

Last Update Posted (Estimate)

February 7, 2013

Last Update Submitted That Met QC Criteria

February 6, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RNN-56-07-KE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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