Nebulized Budesonide for Children Who Are Hospitalized for Acute Wheezing
Primary Purpose
Asthma, Acute Asthma
Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Budesonide 0.5 mg/ml nebules
% 0.9 Saline solution
Sponsored by
About this trial
This is an interventional treatment trial for Asthma focused on measuring Wheezing, Acute asthma, Children
Eligibility Criteria
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
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
2 Placebo saline
Arm Description
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
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
Outcomes
Primary Outcome Measures
Time to discharge from the hospital to home
Secondary Outcome Measures
Pulmonary index score
Respiratory rate
Oxygen saturation
Adverse reactions.
Full Information
NCT ID
NCT00733473
First Posted
August 12, 2008
Last Updated
December 17, 2011
Sponsor
Kecioren Education and Training Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00733473
Brief Title
Nebulized Budesonide for Children Who Are Hospitalized for Acute Wheezing
Official Title
Phase 4 Study of Nebulized Budesonide for Children Who Are Hospitalized for Acute Wheezing
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
January 2010 (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 children who have hospitalized for acute wheezing.
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 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.
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
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
Arm Type
Active Comparator
Arm Description
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
Arm Title
2 Placebo saline
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Budesonide 0.5 mg/ml nebules
Other Intervention Name(s)
Pulmicort 0.5 mg/ml nebules
Intervention Description
Children will receive 1 mg nebulized budesonide 2 times a day up to 5 days
Intervention Type
Drug
Intervention Name(s)
% 0.9 Saline solution
Intervention Description
Children will receive 2 ml of nebulized saline 2 times a day up to 5 days
Primary Outcome Measure Information:
Title
Time to discharge from the hospital to home
Time Frame
1-5 days
Secondary Outcome Measure Information:
Title
Pulmonary index score
Time Frame
1 to 5 days
Title
Respiratory rate
Time Frame
1 to 5 days
Title
Oxygen saturation
Time Frame
1 to 5 days
Title
Adverse reactions.
Time Frame
1 to 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
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
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
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Nebulized Budesonide for Children Who Are Hospitalized for Acute Wheezing
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