Wheezing
Conditions
Keywords
Wheezing, Children
Brief summary
This is a single-centre, open label study, aiming to evaluate the efficacy of beclomethasone dipropionate applied for 12 weeks with a dose of 400 µg twice a day (total dose 800 µg nebulized), on airway resistance and reactances (measured with Rint and FOT techniques) in children with recurrent wheezing, aged 2-5 years. In addition, clinic score as frequency of symptoms and exacerbations, will be assessed.
Interventions
DRUGNebulized beclomethasone dipropionate
Nebulized beclomethasone dipropionate applied for 12 weeks with a dose of 400 µg twice a day (total dose 800 µg)
Sponsors
Istituto per la Ricerca e l'Innovazione Biomedica
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 5 Years
Healthy volunteers
No
Inclusion criteria
* Informed and subscribed consent before any procedure * Age range : 2 - ≤5 years * Male and female patients * Recurrent wheezing affected ( ≥ 4 episodes in the last 12 months) * PAI positive (at least one primary and two secondary ): Primary: 1. one parent with asthma 2. Atopic Dermatitis 3. sensibilisation to air allergen Secondary: 1. Food sensibilization 2. wheezing also not during the infective episodes 3. eosinophilia (\>4%)
Exclusion criteria
* story of severe wheeze requiring hospitalization * treatment with inhaled glucocorticoids during the previous 4 weeks or with oral glucocorticoids in the previous 8 weeks * structural abnormalities of the lungs (tracheobronchial bronchomalacia, external compressions, etc) * Persistent infections * aspiration lung disease (gastroesophageal reflux disease, etc.) * Cystic fibrosis * prematurity or bronchopulmonary dysplasia * Tuberculosis * primary ciliary dyskinesia * congenital heart disease * pulmonary foreign body * bronchiectasis * Immunodeficit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Lung fuction with Rint and FOT | 12 Weeks |
Outcome results
None listed