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NOT YET RECRUITING
NCT07675252
PHASE4

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

Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

View on ClinicalTrials.gov

Summary

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.

Official title: A Multicenter Clinical Study on Efficacy and Safety of Fluticasone Propionate Nebulized Suspension in the Treatment of Wheezing Diseases in Infants Aged 0-24 Months

Key Details

Gender

All

Age Range

0 Months - 24 Months

Study Type

INTERVENTIONAL

Enrollment

240

Start Date

2026-08-01

Completion Date

2027-06-30

Last Updated

2026-06-30

Healthy Volunteers

No

Interventions

DRUG

Fluticasone Propionate Nebulization

0.5mg/2ml, BID

DRUG

Budesonide Nebulization

1mg/2ml, BID