NCT01113489

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy · Other Government
• Sex: All
• Age: 6 Years – 14 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Asthma
• Allergic Rhinitis

Interventions

Type	Name	Description
DRUG	beclomethasone dipropionate	400 mcg/1 ml b.i.d.
DRUG	placebo	1 ml b.i.d.

Timeline

• Start date: 2010-04-01
• Primary completion: 2010-07-01
• Completion: 2010-07-01
• First posted: 2010-04-30
• Last updated: 2010-07-27

Locations

1 site across 1 country: Italy