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Nebulized Budesonide for Children Who Are Hospitalized for Acute Wheezing

NCT ID: NCT00733473

Last Updated: 2011-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2010-01-31

Brief Summary

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The purpose of this study is to determine if adding nebulized budesonide to the systemic steroid for treatment of acute wheezing has any additive benefit in children who have hospitalized for acute wheezing.

Detailed Description

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Context: Inhaled steroids reduced admission rates in patients with acute asthma, but it is unclear if there is a benefit of inhaled corticosteroids when used in addition to systemic corticosteroids. There is insufficient evidence that inhaled corticosteroids result in clinically important changes in pulmonary function or clinical scores when used in acute asthma. Similarly, it was mentioned in the Cochrane Database of Systematic Reviews that further research is needed to clarify if there is a benefit of inhaled corticosteroids when used in addition to systemic steroids.

Objective: To determine if adding nebulized budesonide to the systemic steroid for treatment of acute wheezing in hospitalized children has any benefit on, symptom score, duration of hospitalization and time to discharge from hospital.

Study Design/Setting/Participants: A double-blind, randomized, controlled trial of nebulized budesonide versus placebo for children 6 months to 6 years of age who have admitted to the hospital for acute wheezing.

Intervention: Participants will receive standard therapy including SCS, albuterol, and ipratropium bromide and will be randomly assigned to also receive either nebulized BIS or saline.

Study Measures: Differences in asthma scores, vital signs, duration of hospitalization and time to discharge from hospital will be compared between treatment groups.

Conditions

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Asthma Acute Asthma

Keywords

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Wheezing Acute asthma Children

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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1 Budesonide

This arm consist 50 children with recurrent wheezing who are hospitalized for wheezing epizode. They received 1 mg nebulized budesonide 2 times a day upto 5 days

Group Type ACTIVE_COMPARATOR

Budesonide 0.5 mg/ml nebules

Intervention Type DRUG

Children will receive 1 mg nebulized budesonide 2 times a day up to 5 days

2 Placebo saline

This arm consist 50 children with recurrent wheezing who are hospitalized for wheezing epizode. They received 2ml of nebulized saline 2 times a day upto 5 days

Group Type PLACEBO_COMPARATOR

% 0.9 Saline solution

Intervention Type DRUG

Children will receive 2 ml of nebulized saline 2 times a day up to 5 days

Interventions

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Budesonide 0.5 mg/ml nebules

Children will receive 1 mg nebulized budesonide 2 times a day up to 5 days

Intervention Type DRUG

% 0.9 Saline solution

Children will receive 2 ml of nebulized saline 2 times a day up to 5 days

Intervention Type DRUG

Other Intervention Names

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Pulmicort 0.5 mg/ml nebules

Eligibility Criteria

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Inclusion Criteria

* Children who have recurrent wheezing attacks
* Children who admitted to the hospital for acute wheezing
* Clinical asthma score of 3-9
* Parental/guardian permission (informed consent) and if appropriate, child assent

Exclusion Criteria

* Systemic corticosteroid use in the last 30 days
* Chronic lung diseases including cystic fibrosis
* Immunodeficiency
* Cardiac disease requiring surgery or medications
* Adverse drug reaction or allergy to budesonide, albuterol, ipratropium bromide, prednisone, prednisolone, or methylprednisolone
* Known renal or hepatic dysfunction
* Impending respiratory failure requiring positive pressure ventilation
* Immune deficiency
* Gastroesophageal reflux disease
* Suspected foreign body aspiration or croup
* Anatomic abnormalities of the respiratory tract
Minimum Eligible Age

6 Months

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kecioren Education and Training Hospital

OTHER

Sponsor Role lead

Responsible Party

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Cem Hasan Razi

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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C H Razi, MD

Role: STUDY_DIRECTOR

Kecioren Education and Training Hospital

C H Razi, MD

Role: PRINCIPAL_INVESTIGATOR

Kecioren Education and Training Hospital

Locations

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Kecioren Education and Training Hospital

Ankara, Kecioren, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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B.10.0.İEG.0.11.00.01-3246

Identifier Type: -

Identifier Source: org_study_id