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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| beclomethasone dipropionate suspension for nebulization | Experimental |
| |
| placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| beclomethasone dipropionate | Drug | 400 mcg/1 ml b.i.d. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in level of oral and nasal fractional exhaled nitric oxide (FeNO) | Baseline, 4 weeks |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unit of Immunopathology and Pharmacology of the Respiratory System Institute of Biomedicine and Molecular Immunology (IBIM) Italian National Research (CNR) | Palermo | 90146 | Italy |
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| placebo | Drug | 1 ml b.i.d. |
|
| 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 |
| ID | Term |
|---|---|
| D001249 | Asthma |
| D065631 | Rhinitis, Allergic |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| D001507 | Beclomethasone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013258 | Steroids, Chlorinated |
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