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

Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy

Status and phase

Completed

Phase 3

Conditions

Asthma

Allergic Rhinitis

Treatments

Drug: placebo

Drug: beclomethasone dipropionate

Study type

Interventional

Funder types

Other

Identifiers

NCT01113489

0002565

Details and patient eligibility

About

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.

Enrollment

32 estimated patients

Sex

All

Ages

6 to 14 years old

Volunteers

No Healthy Volunteers

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