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

Phase 3

Completed

• Conditions: Asthma; Allergic Rhinitis
• Interventions: Drug: placebo; Drug: beclomethasone dipropionate

• Registration Number: NCT01113489
• Lead Sponsor: Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-04-15
• Study First Submitted QC: 2010-04-29
• Study First Posted: 2010-04-30
• Status Verified: 2010-05
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Last Update Submitted: 2010-07-26
• Last Update Posted: 2010-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	placebo	-
beclomethasone dipropionate suspension for nebulization	beclomethasone dipropionate	-

Primary Outcome Measures

Name	Time	Method
Change in level of oral and nasal fractional exhaled nitric oxide (FeNO)	Baseline, 4 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Unit of Immunopathology and Pharmacology of the Respiratory System Institute of Biomedicine and Molecular Immunology (IBIM) Italian National Research (CNR); 🇮🇹 Palermo, Italy