Efficacy and Safety of Fluticasone Propionate Nebulized Suspension for Wheezing Diseases in Infants Aged 0-24 Months
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Fluticasone Propionate Nebulization, Budesonide Nebulization.
- Who it may be relevant to
- Registry conditions: Acute Wheezing Disorders in Infants Aged 0 to 24 Months. Basic parameters: 0 months — 24 months · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- Drug Fluticasone Propionate Nebulization
0.5mg/2ml, BID - Drug Budesonide Nebulization
1mg/2ml, BID
Primary outcome measures
- Change from baseline in total wheezing symptom score (wheezing, cough, phlegm, wheeze rales) at Day 5 to Day 7 [Time frame: From baseline to Day 5 to Day 7 of treatment]
Secondary outcome measures (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 [Time frame: 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 [Time frame: From baseline to 24 hours, 48 hours, Day 3, Day 5 to Day 7 of treatment]
- Length of hospital stay [Time frame: up to 7 days]
- Usage of combined rescue drugs [Time frame: up to 7 days]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07675252 · FPNS-IWD