Nebulized Budesonide for Children Who Are Hospitalized for Acute Wheezing
|ClinicalTrials.gov Identifier: NCT00733473|
Recruitment Status : Completed
First Posted : August 13, 2008
Last Update Posted : December 20, 2011
|Condition or disease||Intervention/treatment||Phase|
|Asthma Acute Asthma||Drug: Budesonide 0.5 mg/ml nebules Drug: % 0.9 Saline solution||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Phase 4 Study of Nebulized Budesonide for Children Who Are Hospitalized for Acute Wheezing|
|Study Start Date :||September 2007|
|Actual Primary Completion Date :||December 2009|
|Actual Study Completion Date :||January 2010|
Active Comparator: 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
Drug: Budesonide 0.5 mg/ml nebules
Children will receive 1 mg nebulized budesonide 2 times a day up to 5 days
Other Name: Pulmicort 0.5 mg/ml nebules
Placebo Comparator: 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
Drug: % 0.9 Saline solution
Children will receive 2 ml of nebulized saline 2 times a day up to 5 days
- Time to discharge from the hospital to home [ Time Frame: 1-5 days ]
- Pulmonary index score [ Time Frame: 1 to 5 days ]
- Respiratory rate [ Time Frame: 1 to 5 days ]
- Oxygen saturation [ Time Frame: 1 to 5 days ]
- Adverse reactions. [ Time Frame: 1 to 5 days ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00733473
|Kecioren Education and Training Hospital|
|Ankara, Kecioren, Turkey, 06380|
|Study Director:||C H Razi, MD||Kecioren Education and Training Hospital|
|Principal Investigator:||C H Razi, MD||Kecioren Education and Training Hospital|