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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01113489
• Other study ID #: 0002565
• Status: Completed
• Phase: Phase 3
• First received: April 15, 2010
• Last updated: July 26, 2010
• Start date: April 2010
• Est. completion date: July 2010

Study information

• Verified date: May 2010
• Source: Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: National Bioethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 14 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Allergic Rhinitis
• Asthma

Intervention

Drug:
• beclomethasone dipropionate
400 mcg/1 ml b.i.d.
• placebo
1 ml b.i.d.

Locations

Country	Name	City	State
Italy	Unit of Immunopathology and Pharmacology of the Respiratory System Institute of Biomedicine and Molecular Immunology (IBIM) Italian National Research (CNR)	Palermo

Sponsors (1)

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

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in level of oral and nasal fractional exhaled nitric oxide (FeNO)		Baseline, 4 weeks	No
Secondary	Change in peak expiratory flow (PEF)		Baseline, 4 weeks	No
Secondary	change in visual analogue scale score for symptoms of rhinitis		Baseline, 4 weeks	No
Secondary	change in obstructive sleep apnea syndrome score		Baseline, 4 weeks	No
Secondary	change in forced vital capacity (FVC)		Baseline, 4 weeks	No
Secondary	change in symptom scores of wheezing		Baseline, 4 weeks	No
Secondary	change in forced expiratory volume in 1 second (FEV1)		Baseline, 4 weeks	No
Secondary	change in level of IL-5 in exhaled breath condensate		Baseline, 4 weeks	No