Phase 4 Study of Budesonide for Emergency Treatment of Acute Wheezing in Children
Overview
- Phase
- Phase 4
- Intervention
- 0.5 mg/ml budesonide nebules
- Conditions
- Asthma
- Sponsor
- Kecioren Education and Training Hospital
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Pulmonary index score at 2 to 4 hours
- Status
- Completed
- Last Updated
- 14 years ago
Overview
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.
Investigators
Cem Hasan Razi
MD
Kecioren Education and Training Hospital
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
Arms & Interventions
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
Intervention: 0.5 mg/ml budesonide nebules
2- 0.9% saline
Children will receive 2 ml of saline every 20 minutes for 3 times and will not give after 3 doses
Intervention: Saline
Outcomes
Primary Outcomes
Pulmonary index score at 2 to 4 hours
Time Frame: 2 to 4 hours
Secondary Outcomes
- Hospital admission rates(4 hours)
- Proportion of subjects improving from severe to moderate, severe to mild, and moderate to mild.(4 hours)
- Respiratory rate(2 hours)
- Oxygen saturation(2 hours)
- Time to discharge from the Emergency Department to home(2 to 4 hours)
- Adverse reactions.(2-5 days)