Back to resultsAssessment of Oxidative Stress Markers in the Upper and Lower Airways of Atopic Children Treated With Nebulized Beclomethasone
Primary Purpose
Asthma, Allergic Rhinitis
Status
Completed
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
beclomethasone dipropionate
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Asthma
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
Sites / Locations
- Unit of Immunopathology and Pharmacology of the Respiratory System Institute of Biomedicine and Molecular Immunology (IBIM) Italian National Research (CNR)
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
beclomethasone dipropionate suspension for nebulization
placebo
Arm Description
Outcomes
Primary Outcome Measures
Change in level of oral and nasal fractional exhaled nitric oxide (FeNO)
Secondary Outcome Measures
Change in peak expiratory flow (PEF)
change in visual analogue scale score for symptoms of rhinitis
change in obstructive sleep apnea syndrome score
change in forced vital capacity (FVC)
change in symptom scores of wheezing
change in forced expiratory volume in 1 second (FEV1)
change in level of IL-5 in exhaled breath condensate
Full Information
NCT ID
NCT01113489
First Posted
April 15, 2010
Last Updated
July 26, 2010
Sponsor
Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
1. Study Identification
Unique Protocol Identification Number
NCT01113489
Brief Title
Assessment of Oxidative Stress Markers in the Upper and Lower Airways of Atopic Children Treated With Nebulized Beclomethasone
Official Title
Assessment of Oxidative Stress Markers in the Upper and Lower Airways of Atopic Children Treated With Nebulized Beclomethasone
Study Type
Interventional
2. Study Status
Record Verification Date
May 2010
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma, Allergic Rhinitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
32 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
beclomethasone dipropionate suspension for nebulization
Arm Type
Experimental
Arm Title
placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
beclomethasone dipropionate
Intervention Description
400 mcg/1 ml b.i.d.
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
1 ml b.i.d.
Primary Outcome Measure Information:
Title
Change in level of oral and nasal fractional exhaled nitric oxide (FeNO)
Time Frame
Baseline, 4 weeks
Secondary Outcome Measure Information:
Title
Change in peak expiratory flow (PEF)
Time Frame
Baseline, 4 weeks
Title
change in visual analogue scale score for symptoms of rhinitis
Time Frame
Baseline, 4 weeks
Title
change in obstructive sleep apnea syndrome score
Time Frame
Baseline, 4 weeks
Title
change in forced vital capacity (FVC)
Time Frame
Baseline, 4 weeks
Title
change in symptom scores of wheezing
Time Frame
Baseline, 4 weeks
Title
change in forced expiratory volume in 1 second (FEV1)
Time Frame
Baseline, 4 weeks
Title
change in level of IL-5 in exhaled breath condensate
Time Frame
Baseline, 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Unit of Immunopathology and Pharmacology of the Respiratory System Institute of Biomedicine and Molecular Immunology (IBIM) Italian National Research (CNR)
City
Palermo
ZIP/Postal Code
90146
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
Assessment of Oxidative Stress Markers in the Upper and Lower Airways of Atopic Children Treated With Nebulized Beclomethasone
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