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

January 19, 2017 updated by: Stefania La Grutta, MD, Istituto per la Ricerca e l'Innovazione Biomedica
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 5 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nebulized Beclomethasone dipropionate
Nebulized Beclomethasone dipropionate applied for 12 weeks with a dose of 400 µg twice a day (total dose 800 µg).
Drug: Nebulized beclomethasone dipropionate
Nebulized beclomethasone dipropionate applied for 12 weeks with a dose of 400 µg twice a day (total dose 800 µg)
Other Names:
  • BDP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Lung fuction with Rint and FOT
Time Frame: 12 Weeks
12 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto per la Ricerca e l'Innovazione Biomedica

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

February 12, 2015

First Submitted That Met QC Criteria

March 4, 2015

First Posted (Estimate)

March 6, 2015

Study Record Updates

Last Update Posted (Estimate)

January 20, 2017

Last Update Submitted That Met QC Criteria

January 19, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0000573

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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