Asthma
Conditions
Keywords
asthma, children, EBC, exposure to tabacco, antiasthma treatment
Brief summary
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
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.
Interventions
DRUGcyklezonid
160 mcg once daily
DRUGmontelukast sodium
5 or 10 mg according to age once daily
DRUGplacebo
fluticasone placebo twice daily, montelukast placebo once daily
DRUGformoterol 12 mcg twice daily
formoterol 12 mcg twice daily will be given to children for 3 months
Sponsors
Medical University of Lodz
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| Measurement of FENO, bronchial hyperreactivity, exercise treadmill challenge, lung function and clinical evaluation | visits 1-6 |
Countries
Poland
Contacts
Primary ContactJoanna Jerzynska, MD PhD
Backup ContactIwona Stelmach, MD PhD Prof
Outcome results
None listed