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

NCT07675252 | Not Yet Recruiting Phase 4

• 1 other identifier: FPNS-IWD
• Study Type: interventional
• Target: 240
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

FPN; Wheezing Disorders in Infants; 0 - 24 months

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change from baseline in wheezing symptom and sign score (wheezing, cough, sputum, wheeze rales) at 24 hours, 48 hours and Day 3 of treatment

  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

  From baseline to 24 hours, 48 hours, Day 3, Day 5 to Day 7 of treatment

• Length of hospital stay

  up to 7 days

• Usage of combined rescue drugs

  up to 7 days

Study Arms (2)

FPN

EXPERIMENTAL

0.5mg/2ml, BID

Drug: Fluticasone Propionate Nebulization

BUD

ACTIVE COMPARATOR

1mg/2ml, BID

Drug: Budesonide Nebulization

Interventions

Fluticasone Propionate Nebulization DRUG

0.5mg/2ml, BID

FPN

Budesonide Nebulization DRUG

1mg/2ml, BID

BUD

Eligibility Criteria

• Age: 0 Months - 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine: lead
• Shengjing Hospital: collaborator

Study Officials

• Jianguo Hong, Doctor

  Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

• Jiujun Li, Doctor

  Shengjing Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jianguo Hong, Doctor

CONTACT

+86 18730251574; hongjianguo@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician, Professor

Model Details: 1:1 randomization to two parallel treatment groups.

Study Record Dates

• First Submitted: May 8, 2026
• First Posted: June 30, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: June 30, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share