This study looks at how well and how safe fluticasone propionate nebulized suspension works in babies aged 0 to 24 months who have acute wheezing. Investigators will compare it to budesonide nebulized suspension, another approved inhaled steroid. About 240 babies will join. Participants will be put into two groups by chance (1:1 randomization): One group gets fluticasone propionate 0.5 mg twice a day by nebulizer The other group gets budesonide 1 mg twice a day by nebulizer Treatment lasts 5 to 7 days. Investigators will check breathing symptoms (wheezing, cough, phlegm, wheeze sounds in lungs) every day during treatment. The study will check if fluticasone works as well as budesonide (non-inferiority) and may also check if it works better. Safety will be watched closely, including side effects, general health, and lab tests. This study will help doctors know if fluticasone propionate nebulized suspension is a good treatment option for young babies with wheezing.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
240
0.5mg/2ml, BID
1mg/2ml, BID
Change from baseline in total wheezing symptom score (wheezing, cough, phlegm, wheeze rales) at Day 5 to Day 7
Change from baseline in total wheezing symptom score (wheezing, cough, phlegm, wheeze rales) at Day 5 to Day 7 Infant Wheezing Symptom and Sign Grading Quantitative Scale, score range: 0-12 points, higher scores indicate more severe wheezing symptoms and signs.
Time frame: From baseline to Day 5 to Day 7 of treatment
Change from baseline in wheezing symptom and sign score (wheezing, cough, sputum, wheeze rales) at 24 hours, 48 hours and Day 3 of treatment
Change from baseline in wheezing symptom and sign score (wheezing, cough, sputum, wheeze rales) at 24 hours, 48 hours and Day 3 of treatment Infant Wheezing Symptom and Sign Grading Quantitative Scale, score range: 0- 12 points, higher scores indicate more severe wheezing symptoms and signs.
Time frame: From baseline to 24 hours, 48 hours and Day 3 of treatment
Therapeutic efficacy of wheezing disease at 24 hours, 48 hours, Day 3, Day 5 to Day 7 of treatment
Therapeutic efficacy of wheezing disease at 24 hours, 48 hours, Day 3, Day 5 to Day 7 of treatment. Efficacy is evaluated using an investigator-defined 4-level clinical efficacy scale based on changes in the total score of the Infant Wheezing Symptom and Sign Grading Quantitative Scale (score range: 0-12; higher scores indicate more severe symptoms and signs). Clinical Cure: Complete resolution of clinical symptoms and signs; reduction in total score ≥90%. Marked Improvement: Substantial resolution of clinical symptoms and signs; reduction in total score ≥60% to \<90%. Improvement: Partial resolution or improvement of clinical symptoms and signs; reduction in total score ≥30% to \<60%. No Improvement: Does not meet the above criteria. Overall Response Rate = (Number of participants with Clinical Cure + Marked Improvement + Improvement) / Total number of participants.
Time frame: From baseline to 24 hours, 48 hours, Day 3, Day 5 to Day 7 of treatment
Length of hospital stay
Comparison of hospital stay days
Time frame: up to 7 days
Usage of combined rescue drugs
including the specific drug name, prescribed dosage, detailed administration method and dosage , and specific administration time.
Time frame: up to 7 days
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