Allergic Rhinitis, Asthma
Conditions
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.
Interventions
DRUGbeclomethasone dipropionate
400 mcg/1 ml b.i.d.
DRUGplacebo
1 ml b.i.d.
Sponsors
Fondazione C.N.R./Regione Toscana G. Monasterio, Pisa, Italy
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
6 Years to 14 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in level of oral and nasal fractional exhaled nitric oxide (FeNO) | Baseline, 4 weeks |
Secondary
| Measure | Time frame |
|---|---|
| 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 peak expiratory flow (PEF) | 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 |
| change in symptom scores of wheezing | Baseline, 4 weeks |
Countries
Italy
Outcome results
None listed