New study compares two inhaled steroids for treating wheezing in babies
NCT ID NCT07675252
First seen Jun 30, 2026 · Last updated Jul 01, 2026 · Updated 1 time
Summary
This study tests how well and how safe fluticasone propionate nebulized suspension works in babies aged 0 to 24 months with acute wheezing. It compares fluticasone to budesonide, another commonly used inhaled steroid. About 240 babies will be randomly assigned to receive either fluticasone or budesonide twice daily for 5 to 7 days. Researchers will track breathing symptoms like wheezing, cough, and phlegm to see if fluticasone is as effective as budesonide.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Fluticasone propionate nebulized suspension
- What this could lead to
- If fluticasone works as well or better than budesonide, it could become another safe, effective inhaled steroid option for treating wheezing in very young infants.
- What could go wrong
- This is a Phase 4 trial with 240 babies, so results may not apply to all infants. The treatment is short-term (5-7 days), and long-term effects or rare side effects may not be captured.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
-
About 240 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
-
Aug 2026
An estimate. Start dates often move.
- Expected to finish
-
Jun 2027
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
0 to 24 months
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Acute wheezing disorders in infants aged 0 to 24 months are added.
Genom att skicka in godkänner du våra Användarvillkor
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.