search
Back to results

Budesonide for Emergency Treatment of Acute Wheezing in Children

Primary Purpose

Asthma, Acute Asthma

Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
0.5 mg/ml budesonide nebules
Saline
Sponsored by
Kecioren Education and Training Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring Wheezing, Acute asthma, Children, Budesonide, Emergency room

Eligibility Criteria

6 Months - 6 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Children who have recurrent wheezing attacks and admitted to the emergency room for acute wheezing
  • Pulmonary index score of 7-13
  • 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

Sites / Locations

  • Kecioren Education and Training Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1-Budesonide nebulized suspension

2- 0.9% saline

Arm Description

Children will receive 0.5 mg/ml budesonide nebules every 20 minutes for 3 times and will not give after 3 doses

Children will receive 2 ml of saline every 20 minutes for 3 times and will not give after 3 doses

Outcomes

Primary Outcome Measures

Pulmonary index score at 2 to 4 hours

Secondary Outcome Measures

Hospital admission rates
Proportion of subjects improving from severe to moderate, severe to mild, and moderate to mild.
Respiratory rate
Oxygen saturation
Time to discharge from the Emergency Department to home
Adverse reactions.

Full Information

First Posted
August 12, 2008
Last Updated
December 17, 2011
Sponsor
Kecioren Education and Training Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT00733317
Brief Title
Budesonide for Emergency Treatment of Acute Wheezing in Children
Official Title
Phase 4 Study of Budesonide for Emergency Treatment of Acute Wheezing in Children
Study Type
Interventional

2. Study Status

Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kecioren Education and Training Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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 the emergency room.
Detailed Description
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 the emergency room has any benefit on, symptom score, hospitalization rate and time to discharge from emergency room. 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 emergency room 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, and the need for hospitalization will be compared between treatment groups.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma, Acute Asthma
Keywords
Wheezing, Acute asthma, Children, Budesonide, Emergency room

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1-Budesonide nebulized suspension
Arm Type
Active Comparator
Arm Description
Children will receive 0.5 mg/ml budesonide nebules every 20 minutes for 3 times and will not give after 3 doses
Arm Title
2- 0.9% saline
Arm Type
Placebo Comparator
Arm Description
Children will receive 2 ml of saline every 20 minutes for 3 times and will not give after 3 doses
Intervention Type
Drug
Intervention Name(s)
0.5 mg/ml budesonide nebules
Other Intervention Name(s)
Budesonide 0.5 mg/ml nebules
Intervention Description
Children will receive 0.5 mg/ml budesonide nebules every 20 minutes for 3 times
Intervention Type
Drug
Intervention Name(s)
Saline
Other Intervention Name(s)
0.9% Saline solution
Intervention Description
Children will receive 2 ml of saline every 20 minutes for 3 times
Primary Outcome Measure Information:
Title
Pulmonary index score at 2 to 4 hours
Time Frame
2 to 4 hours
Secondary Outcome Measure Information:
Title
Hospital admission rates
Time Frame
4 hours
Title
Proportion of subjects improving from severe to moderate, severe to mild, and moderate to mild.
Time Frame
4 hours
Title
Respiratory rate
Time Frame
2 hours
Title
Oxygen saturation
Time Frame
2 hours
Title
Time to discharge from the Emergency Department to home
Time Frame
2 to 4 hours
Title
Adverse reactions.
Time Frame
2-5 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Children who have recurrent wheezing attacks and admitted to the emergency room for acute wheezing Pulmonary index score of 7-13 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
C H Razi, MD
Organizational Affiliation
Kecioren Education and Training Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
C H Razi, MD
Organizational Affiliation
Kecioren Education and Training Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kecioren Education and Training Hospital
City
Ankara
State/Province
Kecioren
ZIP/Postal Code
06380
Country
Turkey

12. IPD Sharing Statement

Learn more about this trial

Budesonide for Emergency Treatment of Acute Wheezing in Children

We'll reach out to this number within 24 hrs