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

Primary Purpose

Wheezing

Status

Completed

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Nebulized beclomethasone dipropionate

About this trial

This is an interventional treatment trial for Wheezing focused on measuring Wheezing, Children

Eligibility Criteria

2 Years - 5 Years (Child)All SexesDoes not accept 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:

one parent with asthma
Atopic Dermatitis
sensibilisation to air allergen

Secondary:

Food sensibilization
wheezing also not during the infective episodes
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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Nebulized Beclomethasone dipropionate

Arm Description

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

Outcomes

Primary Outcome Measures

Lung fuction with Rint and FOT

Secondary Outcome Measures

Full Information

NCT ID

NCT02381158

First Posted

February 12, 2015

Last Updated

January 19, 2017

Sponsor

Istituto per la Ricerca e l'Innovazione Biomedica

1. Study Identification

Unique Protocol Identification Number

NCT02381158

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2017

Overall Recruitment Status

Completed

Study Start Date

February 2015 (undefined)

Primary Completion Date

December 2015 (Actual)

Study Completion Date

December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Istituto per la Ricerca e l'Innovazione Biomedica

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Wheezing

Keywords

Wheezing, Children

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Nebulized Beclomethasone dipropionate

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Nebulized beclomethasone dipropionate

Other Intervention Name(s)

BDP

Intervention Description

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

Primary Outcome Measure Information:

Title

Lung fuction with Rint and FOT

Time Frame

12 Weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Years

Maximum Age & Unit of Time

5 Years

Accepts Healthy Volunteers

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: one parent with asthma Atopic Dermatitis sensibilisation to air allergen Secondary: Food sensibilization wheezing also not during the infective episodes 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

12. IPD Sharing Statement

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

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