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

NCT07675252 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2026-06-30

No results posted yet for this study

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.

Conditions

  • Acute Wheezing Disorders in Infants Aged 0 to 24 Months

Interventions

DRUG

Fluticasone Propionate Nebulization

0.5mg/2ml, BID

DRUG

Budesonide Nebulization

1mg/2ml, BID

Sponsors & Collaborators

  • Shengjing Hospital

    collaborator OTHER

  • Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

    lead OTHER

Principal Investigators

  • Jianguo Hong, Doctor · Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

  • Jiujun Li, Doctor · Shengjing Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
0 Months
Max Age
24 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-01
Primary Completion
2027-05-31
Completion
2027-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07675252 on ClinicalTrials.gov