Nebulized Beclomethasone Dipropionate Improves Respiratory Lung Function in Preschool Children With Recurrent Wheezing
Phase 4
Completed
- Conditions
- Wheezing
- Interventions
- Drug: Nebulized beclomethasone dipropionate
- Registration Number
- NCT02381158
- Lead Sponsor
- Istituto per la Ricerca e l'Innovazione Biomedica
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
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:
- one parent with asthma
- Atopic Dermatitis
- sensibilisation to air allergen
Secondary:
- Food sensibilization
- wheezing also not during the infective episodes
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Nebulized Beclomethasone dipropionate Nebulized beclomethasone dipropionate Nebulized Beclomethasone dipropionate applied for 12 weeks with a dose of 400 µg twice a day (total dose 800 µg).
- Primary Outcome Measures
Name Time Method Lung fuction with Rint and FOT 12 Weeks
- Secondary Outcome Measures
Name Time Method