Usefulness of Exhaled Breath Condensate for Evaluation of Markers of Airway Inflammation in Children With Asthma

Study Overview
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Brief Summary
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Exhaled breath condensate (EBC) has emerged as a novel noninvasive technique for assessment of airway inflammation, and it provides information on airway lining fluid composition. Traditionally, such assessment relies on invasive diagnostic tools such as bronchial biopsy and bronchoalveolar lavage (BAL) to obtain specimens from the airway but it is very uncomfortable procedure especially for young patients. The aim of this study is to evaluate the effect of allergic disease, disease monitoring and exposure to tobacco smoke on airway inflammation measured by markers in exhaled breath condensate (EBC) in children with asthma allergic to house dust mite. Also, we aim to assess correlations between cytokine concentrations in EBC and clinical characteristic of the patients with exercise-induced bronchoconstriction as another phenotype of asthma.

Detailed Description
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Markers that can be identified in the EBC of patients with asthma include pH, hydrogen peroxide, nitrogen oxides, eicosanoids, isoprostanes, adenosine, certain cytokines, chemokines, and growth factors. Concentrations of these biomarkers are influenced by inflammation, oxidative stress, and can be modulated by therapeutic interventions. There is evidence that some markers in EBC differ between patients with asthma and controls, and some of them can correlate with asthma severity score, lung function. The aim of this study is to evaluate the effect of allergic disease, disease monitoring and exposure to tobacco smoke on airway inflammation measured by markers in exhaled breath condensate (EBC) in children with asthma allergic to house dust mite. We will also evaluate the effect of antiasthmatic treatment applied out of dust season on the number of exacerbations in asthma epidemic in September. We will evaluate the effect of exposure to tobacco smoke on antiasthmatic treatment. Also, we aim to assess correlations between cytokine concentrations in EBC and clinical characteristic of the patients with exercise-induced bronchoconstriction (EIB) as another phenotype of asthma. At the first study vist patients with EIB underwent fractional exhaled nitric oxide measurement (FeNO) and baseline spirometry, performed exercise treadmill challenge (ETC) and EBC samples were obtained at the end of ETC.

Official Title
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Usefulness of Exhaled Breath Condensate and FENO for Evaluation of Markers of Airway Inflammation in Children With Asthma

Conditions
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Asthma

Intervention / Treatment
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* Drug: cyklezonid
* Drug: montelukast sodium
* Drug: placebo
* Drug: formoterol 12 mcg twice daily


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: children with mild to moderate asthma allergic to house dust mite exposed/nonexposed to tobacco smoke healthy children Exclusion Criteria: sensitization to allergens other than house dust mites other chronic diseases asthma exacerbation pregnancy oral corticosteroids for 4 weeks before the study montelukast sodium for 2 weeks before the study

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: cyklezonid<br>children will receive 160 mcg once daily cyklezonid for 3 months | Drug: cyklezonid<br>* 160 mcg once daily<br>* Other names: Alvesco;|
| Active Comparator: montelukast sodium<br>children will receive 5 or 10 mg montelukast sodium for 3 months | Drug: montelukast sodium<br>* 5 or 10 mg according to age once daily<br>|
| Placebo Comparator: placebo<br>children will receive placebo for 8 weeks out of allergy season to house dust mite | Drug: placebo<br>* fluticasone placebo twice daily, montelukast placebo once daily<br>|
| Active Comparator: formoterol<br>children will receive formoterol aerolzol 12mcg twice daily for 3 months | Drug: formoterol 12 mcg twice daily<br>* formoterol 12 mcg twice daily will be given to children for 3 months<br>* Other names: Formoterol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of IL-4, 5, 6, 8, 16, MIG, TNF- alpha, MCP-1 in EBC. Measurement of ECP, eosinophil blood count, cotinine and total IgE in blood. |  | visit 1-6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of FENO, bronchial hyperreactivity, exercise treadmill challenge, lung function and clinical evaluation |  | visits 1-6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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asthma, children, EBC, exposure to tabacco, antiasthma treatment