Asthma Clinical Trial
Official title:
Phase 4 Study of Nebulized Budesonide for Children Who Are Hospitalized for Acute Wheezing
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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