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

Istituto per la Ricerca e l'Innovazione Biomedica

Status and phase: Completed; Phase 4

Conditions: Wheezing

Treatments: Drug: Nebulized beclomethasone dipropionate

Study type: Interventional

Funder types: Other

Identifiers

NCT02381158

0000573

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 2 to 5 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Nebulized Beclomethasone dipropionate

Experimental group

Description:

Nebulized Beclomethasone dipropionate applied for 12 weeks with a dose of 400 µg twice a day (total dose 800 µg).

Treatment:

Drug: Nebulized beclomethasone dipropionate