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

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

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 Overview

• Status: Not yet recruiting
• Conditions: Acute Wheezing Disorders in Infants Aged 0 to 24 Months
• Intervention / Treatment: Drug: Fluticasone Propionate Nebulization; Drug: Budesonide Nebulization

• Study Type: Interventional
• Enrollment (Estimated): 240
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Jianguo Hong, Doctor; Phone Number: +86 18730251574; Email: hongjianguo@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age: 0-24 months, gender unlimited;
• Clinical diagnosis: infantile wheezing, with the diagnostic criteria referring to Zhu Futang Practical Pediatrics (9th Edition);
• Inpatients with acute clinical manifestations including wheezing, cough, sputum, and bilateral lung wheezes (wheezing and wheezes are mandatory), and the total score of wheezing symptoms and signs (including wheezing + wheezes) ≥ 2 points;
• The onset of the above wheezing symptoms is within 72 hours;
• The guardian of the subject consents and signs the informed consent form.

Exclusion Criteria:

• Children with a clear diagnosis of congenital heart disease (excluding patent ductus arteriosus or patent foramen ovale), primary immunodeficiency, bronchopulmonary dysplasia, bronchiectasis, foreign bodies in the bronchi, pulmonary tuberculosis, or other congenital malformations that may cause wheezing diseases;
• Those with comorbid primary diseases of the circulatory system, digestive system, urinary system, endocrine system, hematopoietic system, and immune system;
• Those with severe respiratory insufficiency;
• Those allergic to the study drugs;
• Those who have received systemic hormone therapy during the current episode of the disease are not eligible for enrollment;

• Before enrollment, any one of the laboratory test indicators meets the following criteria: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) > 2 times the Upper Limit of Normal (ULN) (refer to the normal reference range of laboratory tests in the participating research center); Serum Creatinine (Scr)

  • the Upper Limit of Normal.
• Those who have participated in other clinical trials within the past 90 days are not eligible for enrollment;
• Those who the researcher deems unsuitable for participating in the clinical trial are not eligible for enrollment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FPN; 0.5mg/2ml, BID	Drug: Fluticasone Propionate Nebulization; 0.5mg/2ml, BID
Active Comparator: BUD; 1mg/2ml, BID	Drug: Budesonide Nebulization; 1mg/2ml, BID

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From baseline to Day 5 to Day 7 of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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	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.	up to 7 days

Collaborators and Investigators

• Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
• Collaborators: Shengjing Hospital
• Investigators: Principal Investigator: Jianguo Hong, Doctor, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine; Principal Investigator: Jiujun Li, Doctor, Shengjing Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: May 8, 2026
• First Submitted That Met QC Criteria: June 25, 2026
• First Posted (Actual): June 30, 2026

Study Record Updates

• Last Update Posted (Actual): June 30, 2026
• Last Update Submitted That Met QC Criteria: June 25, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: FPN; Wheezing Disorders in Infants; 0 - 24 months
• Other Study ID Numbers: FPNS-IWD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: De-identified individual participant data (IPD) will not be shared due to institutional data policy and participant privacy protection requirements.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No