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

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.

Study Overview

• Status: Completed
• Conditions: Asthma; Allergic Rhinitis
• Intervention / Treatment: Drug: beclomethasone dipropionate; Drug: placebo

• Study Type: Interventional
• Enrollment (Anticipated): 32
• Phase: Phase 3

Contacts and Locations

Study Locations

• Italy
  • Palermo, Italy, 90146
    • Unit of Immunopathology and Pharmacology of the Respiratory System Institute of Biomedicine and Molecular Immunology (IBIM) Italian National Research (CNR)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 14 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: placebo	Drug: placebo; 1 ml b.i.d.
Experimental: beclomethasone dipropionate suspension for nebulization	Drug: beclomethasone dipropionate; 400 mcg/1 ml b.i.d.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in level of oral and nasal fractional exhaled nitric oxide (FeNO)	Baseline, 4 weeks

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (Actual): July 1, 2010
• Study Completion (Actual): July 1, 2010

Study Registration Dates

• First Submitted: April 15, 2010
• First Submitted That Met QC Criteria: April 29, 2010
• First Posted (Estimate): April 30, 2010

Study Record Updates

• Last Update Posted (Estimate): July 27, 2010
• Last Update Submitted That Met QC Criteria: July 26, 2010
• Last Verified: May 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic; Physiological Effects of Drugs; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Anti-Asthmatic Agents; Respiratory System Agents; Beclomethasone
• Other Study ID Numbers: 0002565