Acute Wheezing Disorders in Infants Aged 0 to 24 MonthsPhase 4FPNS-IWDNCT07675252
Efficacy and Safety of Fluticasone Propionate Nebulized Suspension for Wheezing Diseases in Infants Aged 0-24 Months
A Phase 4 study testing Fluticasone Propionate Nebulization and Budesonide Nebulization in people with Acute Wheezing Disorders in Infants Aged 0 to 24 Months, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 24 months
- Conditions the study is for
- Acute Wheezing Disorders in Infants Aged 0 to 24 Months
- What is being tested?
- Fluticasone Propionate Nebulization and Budesonide Nebulization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2026to 30 Jun 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 24 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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)
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
Read more
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.
- Being tested
- Fluticasone Propionate Nebulization, Budesonide Nebulization
- Keywords
- FPN, Wheezing Disorders in Infants, 0 - 24 months
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluticasone Propionate NebulizationDrug
0.5mg/2ml, BID
Budesonide NebulizationDrug
1mg/2ml, BID
| Study group | Role | What they receive |
|---|---|---|
| FPN | Experimental | 0.5mg/2ml, BID Receives: Drug: Fluticasone Propionate Nebulization |
| BUD | Active comparator | 1mg/2ml, BID Receives: Drug: Budesonide Nebulization |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Change from baseline in wheezing symptom and sign score (wheezing, cough, sputum, wheeze rales) at 24 hours, 48 hours and Day 3 of treatment Infant Wheezing Symptom and Sign Grading Quantitative Scale, score range: 0- 12 points, higher scores indicate more severe wheezing symptoms and signs.
Measured: 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
Therapeutic efficacy of wheezing disease at 24 hours, 48 hours, Day 3, Day 5 to Day 7 of treatment.
Efficacy is evaluated using an investigator-defined 4-level clinical efficacy scale based on changes in the total score of the Infant Wheezing Symptom and Sign Grading Quantitative Scale (score range: 0-12; higher scores indicate more severe symptoms and signs).
Clinical Cure: Complete resolution of clinical symptoms and signs; reduction in total score ≥90%.
Marked Improvement: Substantial resolution of clinical symptoms and signs; reduction in total score ≥60% to <90%.
Improvement: Partial resolution or improvement of clinical symptoms and signs; reduction in total score ≥30% to <60%.
No Improvement: Does not meet the above criteria. Overall Response Rate = (Number of participants with Clinical Cure + Marked Improvement + Improvement) / Total number of participants.
Measured: From baseline to 24 hours, 48 hours, Day 3, Day 5 to Day 7 of treatment
Length of hospital stay
Comparison of hospital stay days
Measured: up to 7 days
Usage of combined rescue drugs
including the specific drug name, prescribed dosage, detailed administration method and dosage , and specific administration time.
Measured: up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2026
- Study start1 Aug 2026 (estimated)
- Primary completion31 May 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Wheezing Disorders in Infants Aged 0 to 24 MonthsStudies of the same condition, open and under way.
- More trials run by Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1:1 randomization to two parallel treatment groups.
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Shengjing Hospital
- Responsible party
- Principal investigator, Jianguo Hong, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- Investigators
- Jianguo Hong, Doctor, Principal investigator, Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineJiujun Li, Doctor, Principal investigator, Shengjing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07675252
- Sponsor's protocol ID
- FPNS-IWD
- Acronym
- FPNS-IWD
- Status last verified
- Jun 2026
- First submitted
- 8 May 2026
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified individual participant data (IPD) will not be shared due to institutional data policy and participant privacy protection requirements.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07675252
- Acronym / sponsor ID
- FPNS-IWD / FPNS-IWD
- Keywords
- FPN, Wheezing Disorders in Infants, 0 - 24 months
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Collaborators
- Shengjing Hospital
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 30 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 1:1 randomization to two parallel treatment groups.
| Arm | Type | Receives |
|---|---|---|
| FPN | Experimental | Drug: Fluticasone Propionate Nebulization0.5mg/2ml, BID |
| BUD | Active comparator | Drug: Budesonide Nebulization1mg/2ml, BID |
Who may qualify
- Ages
- 0 to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluticasone Propionate Nebulization0.5mg/2ml, BID | Drug | FPN |
| Budesonide Nebulization1mg/2ml, BID | Drug | BUD |
Primary outcome
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
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.
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Individual participant dataSharing planned: No. De-identified individual participant data (IPD) will not be shared due to institutional data policy and participant privacy protection requirements.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jianguo Hong, Doctor principal investigator
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Jiujun Li, Doctor principal investigator
Shengjing Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fluticasone Propionate Nebulization and Budesonide Nebulization in people with Acute Wheezing Disorders in Infants Aged 0 to 24 Months, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jianguo Hong, Doctor (+86 18730251574, hongjianguo@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.