Assessment of Oxidative Stress Markers in the Upper and Lower Airways of Atopic Children Treated With Nebulized Beclomethasone

Study Overview
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Brief Summary
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Although it is well known that the presence of uncontrolled inflammation in upper airways may compromise the control of asthma and may favor the progression of asthma toward more severe grades of disease, few studies addressed whether therapies aimed to control both upper and lower airway inflammation may be more effective in controlling asthma. Markers of oxidative stress and of inflammation such as Nitrotyrosine and IL-5 are increased in the airways of children with atopic asthma and correlated with the levels of oral and nasal FeNO, and with the grade of atopy. We hypothesize that the treatment with Beclometasone nebulized with a facial mask (for treating both upper and lower airways) will be able to reduce the production of oxidants as well as of IL5 in both districts thus promoting clinical and functional improvements in mild intermittent asthmatic children. The results provided by this study will contribute to further clarify the relationship between nasal and bronchial inflammation.

Official Title
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Assessment of Oxidative Stress Markers in the Upper and Lower Airways of Atopic Children Treated With Nebulized Beclomethasone

Conditions
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Asthma, Allergic Rhinitis

Intervention / Treatment
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* Drug: beclomethasone dipropionate
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: children with intermittent asthma and allergic rhinitis Exclusion Criteria: children with acute respiratory symptoms in the last 4 weeks children with nasal polyposis or bronchial or respiratory tract infections children with a severe exacerbation of asthma resulting in hospitalization during the last month

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: beclomethasone dipropionate suspension for nebulization<br> | Drug: beclomethasone dipropionate<br>* 400 mcg/1 ml b.i.d.<br>|
| Placebo Comparator: placebo<br> | Drug: placebo<br>* 1 ml b.i.d.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in level of oral and nasal fractional exhaled nitric oxide (FeNO) |  | Baseline, 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in peak expiratory flow (PEF) |  | Baseline, 4 weeks | 
| change in visual analogue scale score for symptoms of rhinitis |  | Baseline, 4 weeks | 
| change in obstructive sleep apnea syndrome score |  | Baseline, 4 weeks | 
| change in forced vital capacity (FVC) |  | Baseline, 4 weeks | 
| change in symptom scores of wheezing |  | Baseline, 4 weeks | 
| change in forced expiratory volume in 1 second (FEV1) |  | Baseline, 4 weeks | 
| change in level of IL-5 in exhaled breath condensate |  | Baseline, 4 weeks |