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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
100
Children will receive 1 mg nebulized budesonide 2 times a day up to 5 days
Children will receive 2 ml of nebulized saline 2 times a day up to 5 days
Kecioren Education and Training Hospital
Ankara, Kecioren, Turkey (Türkiye)
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.