Clinical Research Directory

Efficacy and Safety of Fluticasone Propionate Nebulized Suspension for Wheezing Diseases in Infants Aged 0-24 Months

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.