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.
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;
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;
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Lead sponsor
Shengjing Hospital
Collaborator