Budesonide for Emergency Treatment of Acute Wheezing in Children
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|ClinicalTrials.gov Identifier: NCT00733317|
Recruitment Status : Completed
First Posted : August 13, 2008
Last Update Posted : December 20, 2011
|Condition or disease||Intervention/treatment||Phase|
|Asthma Acute Asthma||Drug: 0.5 mg/ml budesonide nebules Drug: Saline||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 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.
|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 Budesonide for Emergency Treatment of Acute Wheezing in Children|
|Study Start Date :||September 2007|
|Actual Primary Completion Date :||December 2009|
|Actual Study Completion Date :||December 2009|
Active Comparator: 1-Budesonide nebulized suspension
Children will receive 0.5 mg/ml budesonide nebules every 20 minutes for 3 times and will not give after 3 doses
Drug: 0.5 mg/ml budesonide nebules
Children will receive 0.5 mg/ml budesonide nebules every 20 minutes for 3 times
Other Name: Budesonide 0.5 mg/ml nebules
Placebo Comparator: 2- 0.9% saline
Children will receive 2 ml of saline 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
Other Name: 0.9% Saline solution
- Pulmonary index score at 2 to 4 hours [ Time Frame: 2 to 4 hours ]
- Hospital admission rates [ Time Frame: 4 hours ]
- Proportion of subjects improving from severe to moderate, severe to mild, and moderate to mild. [ Time Frame: 4 hours ]
- Respiratory rate [ Time Frame: 2 hours ]
- Oxygen saturation [ Time Frame: 2 hours ]
- Time to discharge from the Emergency Department to home [ Time Frame: 2 to 4 hours ]
- Adverse reactions. [ Time Frame: 2-5 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00733317
|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|