Nebulized Beclomethasone Dipropionate Improves Respiratory Lung Function in Preschool Children With Recurrent Wheezing
Overview
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.
Study Type
- Study Type: Interventional
- Study Design
- Allocation: N/A
- Intervention Model: Single Group Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: December 2015
Interventions
- Drug: Nebulized beclomethasone dipropionate
- Nebulized beclomethasone dipropionate applied for 12 weeks with a dose of 400 µg twice a day (total dose 800 µg)
Arms, Groups and Cohorts
- Experimental: Nebulized Beclomethasone dipropionate
- Nebulized Beclomethasone dipropionate applied for 12 weeks with a dose of 400 µg twice a day (total dose 800 µg).
Clinical Trial Outcome Measures
Primary Measures
- Lung fuction with Rint and FOT
- Time Frame: 12 Weeks
Participating in This Clinical Trial
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
Gender Eligibility: All
Minimum Age: 2 Years
Maximum Age: 5 Years
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Istituto per la Ricerca e l’Innovazione Biomedica
- Provider of Information About this Clinical Study
- Principal Investigator: Stefania La Grutta, MD, MD – Istituto per la Ricerca e l’Innovazione Biomedica
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