Nebulized Beclomethasone Dipropionate Improves Respiratory Lung Function in Preschool Children With Recurrent Wheezing

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Istituto di Biomedicina e Immunologia Molecolare Alberto Monroy; Istituto per la Ricerca e l'Innovazione Biomedica
• Treatments: Beclomethasone

Criteria

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