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

Primary Purpose

Asthma

Status

Unknown status

Phase

Phase 4

Locations

Poland

Study Type

Interventional

Intervention

exhaled nitric oxide measurement

bronchial hyperresponsiveness with methacholine (PC20M)

symptom score diary (according to 2007 GINA guidelines)

About this trial

This is an interventional diagnostic trial for Asthma focused on measuring exhaled nitric oxide, asthma, children, inhaled glucocorticosteroids

Eligibility Criteria

6 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Department of Pediatrics and Allergy, Medical University of Lodz, Lodz, PolandRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

Arm Description

children with asthma with FeNO monitored treatment (study group)

group of children with treatment monitored by GINA's grade of disease clinical control (control group)

Outcomes

Primary Outcome Measures

Control of the disease

Secondary Outcome Measures

Full Information

NCT ID

NCT00500253

First Posted

July 11, 2007

Last Updated

February 6, 2013

Sponsor

Medical University of Lodz

1. Study Identification

Unique Protocol Identification Number

NCT00500253

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2013

Overall Recruitment Status

Unknown status

Study Start Date

February 2007 (undefined)

Primary Completion Date

November 2013 (Anticipated)

Study Completion Date

December 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Medical University of Lodz

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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: 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) Assessment of corelation of FeNO (ppb) with symptom score (points)and lung function (FEV1) Comparison of values of non-specific bronchial hyperresponsiveness with methacholine (PC20M)between both study groups after 12. months of 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: 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) Assessment of corelation of FeNO (ppb) with symptom score (points)and lung function (FEV1) Comparison of values of non-specific bronchial hyperresponsiveness with methacholine (PC20M)between both study groups after 12. months of treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Asthma

Keywords

exhaled nitric oxide, asthma, children, inhaled glucocorticosteroids

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

children with asthma with FeNO monitored treatment (study group)

Arm Title

Arm Type

Other

Arm Description

group of children with treatment monitored by GINA's grade of disease clinical control (control group)

Intervention Type

Device

Intervention Name(s)

exhaled nitric oxide measurement

Other Intervention Name(s)

exhaled nitric oxide measurement (Sievers FeNO analyzer)

Intervention Description

exhaled nitric oxide measurement

Intervention Type

Procedure

Intervention Name(s)

bronchial hyperresponsiveness with methacholine (PC20M)

Other Intervention Name(s)

PC20M Jaeger APS system

Intervention Description

bronchial hyperresponsiveness with methacholine (PC20M)

Intervention Type

Procedure

Intervention Name(s)

symptom score diary (according to 2007 GINA guidelines)

Intervention Description

symptom score diary (according to 2007 GINA guidelines)

Primary Outcome Measure Information:

Title

Control of the disease

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Anna Sołoniewicz, MD

Phone

00 48 42 6895972

alergol@kopernik.lodz.pl

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Anna Sołoniewicz, MD

Organizational Affiliation

Department of Pediatrics and Allergy, Medical University of Lodz, Poland

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Iwona Stelmach, MD, PhD, Prof

Organizational Affiliation

Department of Pediatrics and Allergy, Medical University of Lodz, Poland

Official's Role

Study Chair

Facility Information:

Facility Name

Department of Pediatrics and Allergy, Medical University of Lodz, Lodz, Poland

City

Lodz

ZIP/Postal Code

93-513

Country

Poland

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Anna Sołoniewicz, MD

Phone

00 48 42 6895972

alergol@kopernik.lodz.pl

First Name & Middle Initial & Last Name & Degree

Anna Sołoniewicz, MD

First Name & Middle Initial & Last Name & Degree

Iwona Stelmach, MD, PhD, Prof

12. IPD Sharing Statement

Learn more about this trial

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

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