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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cyklezonid | Active Comparator | children will receive 160 mcg once daily cyklezonid for 3 months |
|
| montelukast sodium | Active Comparator | children will receive 5 or 10 mg montelukast sodium for 3 months |
|
| placebo | Placebo Comparator | children will receive placebo for 8 weeks out of allergy season to house dust mite |
|
| formoterol | Active Comparator | children will receive formoterol aerolzol 12mcg twice daily for 3 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cyklezonid | Drug | 160 mcg once daily |
|
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| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of FENO, bronchial hyperreactivity, exercise treadmill challenge, lung function and clinical evaluation | visits 1-6 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Joanna Jerzynska, MD PhD | Contact | 0048607153123 | joannajerzynska@gmail.com | |
| Iwona Stelmach, MD PhD Prof | Contact | 0048426895972 |
| Name | Affiliation | Role |
|---|---|---|
| Joanna Jerzynska, MD PhD | Department of Pediatrics and Allergy, Medical University of Lodz, Poland | Principal Investigator |
| Iwona Stelmach, MD PhD Prof | Department of Pediatrics and Allergy, Medical University of Lodz, Poland |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Pediatrics and Allergy, Medical University of Lodz, Poland | Recruiting | Lodz | Łódź Voivodeship | Poland |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| C120481 | ciclesonide |
| C093875 | montelukast |
| D000068759 | Formoterol Fumarate |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| montelukast sodium | Drug | 5 or 10 mg according to age once daily |
|
| placebo | Drug | fluticasone placebo twice daily, montelukast placebo once daily |
|
| formoterol 12 mcg twice daily | Drug | formoterol 12 mcg twice daily will be given to children for 3 months |
|
|
| Agnieszka Brzozowska, MD, PhD | Department of Pediatrics and Allergy, Medical University of Lodz, Poland | Principal Investigator |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D000588 |
| Amines |