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

NCT ID: NCT02381158

Last Updated: 2017-01-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2015-12-31

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.

Conditions

Wheezing

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Nebulized Beclomethasone dipropionate

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

Group Type: EXPERIMENTAL

Nebulized beclomethasone dipropionate

Intervention Type: DRUG

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

Interventions

Nebulized beclomethasone dipropionate

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

Intervention Type: DRUG

Other Intervention Names

BDP

Eligibility 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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istituto per la Ricerca e l'Innovazione Biomedica

OTHER

Sponsor Role: lead

Responsible Party

Stefania La Grutta, MD

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

0000573

Identifier Type: -

Identifier Source: org_study_id