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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00500253
• Other study ID #: RNN-56-07-KE
• Status: Recruiting
• Phase: Phase 4
• First received: July 11, 2007
• Last updated: February 6, 2013
• Start date: February 2007
• Est. completion date: December 2013

Study information

• Verified date: February 2013
• Source: Medical Universtity of Lodz
• Contact: Anna Soloniewicz, MD
• Phone: 00 48 42 6895972
• Email: alergol[@]kopernik.lodz.pl
• Is FDA regulated: No
• Health authority: Poland: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 18 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Asthma

Intervention

Device:
• exhaled nitric oxide measurement
exhaled nitric oxide measurement

Procedure:
• bronchial hyperresponsiveness with methacholine (PC20M)
bronchial hyperresponsiveness with methacholine (PC20M)
• symptom score diary (according to 2007 GINA guidelines)
symptom score diary (according to 2007 GINA guidelines)

Locations

Country	Name	City	State
Poland	Department of Pediatrics and Allergy, Medical University of Lodz, Lodz, Poland	Lodz

Sponsors (1)

Lead Sponsor	Collaborator
Medical Universtity of Lodz

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Control of the disease		1 year	No