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New study compares two inhaled steroids for treating wheezing in babies

NCT ID NCT07675252

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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.

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As listed by the trial registrant

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