Acute Asthma, Asthma
Conditions
Keywords
Wheezing, Acute asthma, Children, Budesonide, Emergency room
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.
Interventions
DRUG0.5 mg/ml budesonide nebules
Children will receive 0.5 mg/ml budesonide nebules every 20 minutes for 3 times
DRUGSaline
Children will receive 2 ml of saline every 20 minutes for 3 times
Sponsors
Kecioren Education and Training Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Months to 6 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pulmonary index score at 2 to 4 hours | 2 to 4 hours |
Secondary
| Measure | Time frame |
|---|---|
| Adverse reactions. | 2-5 days |
| Hospital admission rates | 4 hours |
| Time to discharge from the Emergency Department to home | 2 to 4 hours |
| Respiratory rate | 2 hours |
| Oxygen saturation | 2 hours |
| Proportion of subjects improving from severe to moderate, severe to mild, and moderate to mild. | 4 hours |
Countries
Turkey (Türkiye)
Outcome results
None listed