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

NCT ID: NCT01113489

Last Updated: 2010-07-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2010-07-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

beclomethasone dipropionate suspension for nebulization

Group Type: EXPERIMENTAL

beclomethasone dipropionate

Intervention Type: DRUG

400 mcg/1 ml b.i.d.

placebo

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

1 ml b.i.d.

Interventions

beclomethasone dipropionate

400 mcg/1 ml b.i.d.

Intervention Type: DRUG

placebo

1 ml b.i.d.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER_GOV

Sponsor Role: lead

Responsible Party

National Research Council, Italy

Locations

Unit of Immunopathology and Pharmacology of the Respiratory System Institute of Biomedicine and Molecular Immunology (IBIM) Italian National Research (CNR)

Palermo, , Italy

Countries

Italy

Other Identifiers

0002565

Identifier Type: -

Identifier Source: org_study_id