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

NCT02381158 | Completed Phase 4

• 1 other identifier: 0000573
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

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

Keywords

Wheezing; Children

Outcome Measures

Primary Outcomes (1)

• Lung fuction with Rint and FOT

  12 Weeks

Study Arms (1)

Nebulized Beclomethasone dipropionate

EXPERIMENTAL

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

Drug: Nebulized beclomethasone dipropionate

Interventions

Nebulized beclomethasone dipropionate DRUG

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

Also known as: BDP

Nebulized Beclomethasone dipropionate

Eligibility Criteria

• Age: 2 Years - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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:
• one parent with asthma
• Atopic Dermatitis
• sensibilisation to air allergen
• Secondary:
• Food sensibilization
• wheezing also not during the infective episodes
• eosinophilia (\>4%)

You may not qualify if:

• 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

Sponsors & Collaborators

• Istituto per la Ricerca e l'Innovazione Biomedica: lead

MeSH Terms

Conditions

Respiratory Sounds

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 12, 2015
• First Posted: March 6, 2015
• Study Start: February 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: January 20, 2017

Record last verified: 2017-01