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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