Clinical trial NCT00500253: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Asthma
Keywords: exhaled nitric oxide
asthma
children
inhaled glucocorticosteroids
Lead sponsor: Medical University of Lodz
Sponsor class: OTHER
First posted: 2007-07-12
Enrollment: 120
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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:

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.

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 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

Primary outcomes:
measure: Control of the disease
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Lodz
country: Poland
facility: Department of Pediatrics and Allergy, Medical University of Lodz, Lodz, Poland
Study officials:
affiliation: Department of Pediatrics and Allergy, Medical University of Lodz, Poland
name: Anna Sołoniewicz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Pediatrics and Allergy, Medical University of Lodz, Poland
name: Iwona Stelmach, MD, PhD, Prof
role: STUDY_CHAIR
References: