BronchiolitisNCT06827249
Peginterferon α-2b Injection for the Treatment of Pediatric RSV Bronchiolitis
A study testing Peginterferon α-2b injection and Recombinant Human Interferon α2b in people with Bronchiolitis, run by Children's Hospital of Soochow University at 3 sites in China.
Trial summary
This is a multicenter, randomized, positive-controlled, non-inferiority clinical study, planning to enroll 90 children with bronchiolitis caused by respiratory syncytial virus infection, to evaluate the safety and efficacy of inhaled Peginterferon α-2b injection compared to recombinant human interferon α2b in the… Read more about this study
- Who is it for?
- Ages 6 months to 2 years
- Conditions the study is for
- Bronchiolitis
- What is being tested?
- Peginterferon α-2b injection and Recombinant Human Interferon α2b
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 3 sitesChina
- Study dates
- Mar 2025to Jun 2027
- Phase
- Interventional
- 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 6 months to 2 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- The guardian of the child is able to understand the content, requirements, and limitations of the protocol, fully understands the possible adverse reactions that may occur during the study, is willing to complete the follow-up as required, and voluntarily signs the informed consent form before the start of the study.
- The child's age is 6 months or older but no more than 2 years old (including the critical value) at the time of signing the informed consent, and the gender is not specified.
- Positive viral detection in nasopharyngeal swab.
- Presence of rapid breathing, wheezing, moist rales and/or wheezing sounds in the lungs; with or without chest imaging showing signs of hyperinflation, patchy infiltrates, localized atelectasis, and peribronchitis.
- The severity of the illness is mild or moderate (evaluation criteria see Appendix 1: Wang Bronchiolitis Scoring Standard).
- The time from the onset of the child's illness to the signing of the informed consent form is within 72 hours (the appearance of symptoms and signs related to RSV bronchiolitis does not exceed 72 hours from the signing of the informed consent, including but not limited to: tachypnea, wheezing, hypoxemia, dyspnea, fever).
- No use of other antiviral drugs or immunomodulators within 3 weeks before randomization.
Who cannot join
- Extreme restlessness, drowsiness, coma, and possibly requiring mechanical ventilation assistance for breathing.
- Presence of other chronic severe diseases such as cardiac insufficiency, respiratory insufficiency, liver insufficiency, renal insufficiency, and severe malnutrition.
- Having autoimmune diseases such as systemic lupus erythematosus or psoriasis, or immunodeficiency diseases.
- Having epilepsy or other disorders of central nervous system function.
- The investigator's comprehensive judgment suspects a concurrent bacterial infection.
- Clinical diagnosis of myocarditis or suspected myocarditis (diagnostic criteria see Appendix 2: Diagnostic Recommendations for Myocarditis in Children).
Show all 9Show fewer
- Known or suspected allergy to interferon or excipients.
- Participation in other interventional clinical trials within 3 months prior to screening, or planning to participate in other clinical trials during the study period. (9) A history of pneumonia in the past 3 months.
- Other conditions deemed unsuitable for inclusion by the investigator.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites, 3 recruiting
- Not yet recruiting
The First Hospital of Jilin University
Changchun, Jilin
Fanzheng Meng, Ph.D
- Recruiting
Children's Hospital of Soochow University
Suzhou, Jiangsu
Chuangli Hao, Ph.D, hcl_md@163.com
- Not yet recruiting
Wuhan Women and Children's Health Care Center
Wuhan, Hubei
Xiaoxia Lu, Ph.D
About this study
Official title: A Multicenter, Randomized, Positive-controlled, Non-inferiority Clinical Study to Evaluate the Safety and Efficacy of Peginterferon α2b Injection in the Treatment of Pediatric RSV Bronchiolitis
This is a multicenter, randomized, positive-controlled, non-inferiority clinical study, planning to enroll 90 children with bronchiolitis caused by respiratory syncytial virus infection, to evaluate the safety and efficacy of inhaled Peginterferon α-2b injection compared to recombinant human interferon α2b in the treatment of pediatric respiratory syncytial virus bronchiolitis.
- Conditions
- Bronchiolitis
- Being tested
- Peginterferon α-2b injection, Recombinant Human Interferon α2b
- Keywords
- Bronchiolitis, Peginterferon α-2b, respiratory syncytial virus
- Medical subject headings
- Bronchiolitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peginterferon α-2b injectionDrug
Peginterferon α-2b injection, 90 mcg, on the basis of conventional treatments such as asthma control, oxygen inhalation, and fluid replacement, nebulized inhalation using air compression or oxygen-driven methods is administered on days 1, 3, and 5, once a day.
Recombinant Human Interferon α2bDrug
Recombinant Human Interferon alpha 2b, at a dose of 100,000 IU/kg, based on the conventional treatments such as asthma control, oxygen inhalation, and fluid replacement, will be administered via nebulized inhalation using air compression or oxygen-driven methods from day 1 to day 5, twice daily.
| Study group | Role | What they receive |
|---|---|---|
| Peginterferon α-2b 90 mcg dose group | Experimental | The experimental group participants inhaled Peginterferon on the basis of receiving symptomatic supportive treatment. Receives: Drug: Peginterferon α-2b injection |
| Recombinant human interferon α-2b dose group | Active comparator | The control group participants received symptomatic supportive treatment and aerosolized inhalation therapy with recombinant human interferon α-2b. Receives: Drug: Recombinant Human Interferon α2b |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of change in Wang's bronchiolitis score from baseline.
Measured: Day 6.
Secondary outcomes (9)
Wang's bronchiolitis score change from baseline.
Measured: Day1-7.
The proportion of Wang's bronchiolitis score being 0 points.
Measured: Day6.
Length of hospital stay.
Measured: through study completion, an average of 18 months
Duration of oxygen therapy support.
Measured: through study completion, an average of 18 months
Change in viral load from baseline.
Measured: through study completion, an average of 18 months
Adverse Event(AE).
Measured: through study completion, an average of 18 months
Body temperature.
Measured: through study completion, an average of 18 months
Number of Participants with Abnormal Laboratory Parameters Findings.
Measured: through study completion, an average of 18 months
The number of research subjects who withdrew early.
Measured: through study completion, an average of 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2025
- Study startMar 2025 (estimated)
- Primary completionJun 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BronchiolitisStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Soochow University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hao Chuangli, Children's Hospital of Soochow University
- Investigators
- Chuangli Hao, Ph.D, Principal investigator, Children's Hospital of Soochow UniversityFanzheng Meng, Ph.D, Study director, The First Hospital of Jilin UniversityXiaoxia Lu, Ph.D, Study director, Wuhan women and children's health care center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06827249
- Sponsor's protocol ID
- Peg IFN α- 2b and atomization
- Status last verified
- Feb 2025
- First submitted
- 21 Jan 2025
- Last updated
- 14 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Positive-controlled, Non-inferiority Clinical Study to Evaluate the Safety and Efficacy of Peginterferon α2b Injection in the Treatment of Pediatric RSV Bronchiolitis
- ClinicalTrials.gov ID
- NCT06827249
- Acronym / sponsor ID
- Peg IFN α- 2b and atomization
- Conditions
- Bronchiolitis
- Keywords
- Bronchiolitis, Peginterferon α-2b, respiratory syncytial virus
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Children's Hospital of Soochow UniversityUniversity, hospital or other
- Study start
- Mar 2025 (estimated)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 14 Feb 2025 (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 is a multicenter, randomized, positive-controlled, non-inferiority clinical study, planning to enroll 90 children with bronchiolitis caused by respiratory syncytial virus infection, to evaluate the safety and efficacy of inhaled Peginterferon α-2b injection compared to recombinant human interferon α2b in the treatment of pediatric respiratory syncytial virus bronchiolitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peginterferon α-2b 90 mcg dose group | Experimental | Drug: Peginterferon α-2b injectionThe experimental group participants inhaled Peginterferon on the basis of receiving symptomatic supportive treatment. |
| Recombinant human interferon α-2b dose group | Active comparator | Drug: Recombinant Human Interferon α2bThe control group participants received symptomatic supportive treatment and aerosolized inhalation therapy with recombinant human interferon α-2b. |
Who may qualify
- Ages
- 6 months to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- The guardian of the child is able to understand the content, requirements, and limitations of the protocol, fully understands the possible adverse reactions that may occur during the study, is willing to complete the follow-up as required, and voluntarily signs the informed consent form before the start of the study.
- The child's age is 6 months or older but no more than 2 years old (including the critical value) at the time of signing the informed consent, and the gender is not specified.
- Positive viral detection in nasopharyngeal swab.
- Presence of rapid breathing, wheezing, moist rales and/or wheezing sounds in the lungs; with or without chest imaging showing signs of hyperinflation, patchy infiltrates, localized atelectasis, and peribronchitis.
- The severity of the illness is mild or moderate (evaluation criteria see Appendix 1: Wang Bronchiolitis Scoring Standard).
Key exclusion criteria (9 listed)
- Extreme restlessness, drowsiness, coma, and possibly requiring mechanical ventilation assistance for breathing.
- Presence of other chronic severe diseases such as cardiac insufficiency, respiratory insufficiency, liver insufficiency, renal insufficiency, and severe malnutrition.
- Having autoimmune diseases such as systemic lupus erythematosus or psoriasis, or immunodeficiency diseases.
- Having epilepsy or other disorders of central nervous system function.
- The investigator's comprehensive judgment suspects a concurrent bacterial infection.
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 |
|---|---|---|
| Peginterferon α-2b injectionPeginterferon α-2b injection, 90 mcg, on the basis of conventional treatments such as asthma control, oxygen inhalation, and fluid replacement, nebulized inhalation using air compression or oxygen-driven methods is administered on days 1, 3, and 5, once a day. | Drug | Peginterferon α-2b 90 mcg dose group |
| Recombinant Human Interferon α2bRecombinant Human Interferon alpha 2b, at a dose of 100,000 IU/kg, based on the conventional treatments such as asthma control, oxygen inhalation, and fluid replacement, will be administered via nebulized inhalation using air compression or oxygen-driven methods from day 1 to day 5, twice daily. | Drug | Recombinant human interferon α-2b dose group |
Primary outcome
The rate of change in Wang's bronchiolitis score from baseline.
Time frame: Day 6.
9 secondary outcomes
Wang's bronchiolitis score change from baseline.
Time frame: Day1-7.
The proportion of Wang's bronchiolitis score being 0 points.
Time frame: Day6.
Length of hospital stay.
Time frame: through study completion, an average of 18 months
Duration of oxygen therapy support.
Time frame: through study completion, an average of 18 months
Change in viral load from baseline.
Time frame: through study completion, an average of 18 months
Adverse Event(AE).
Time frame: through study completion, an average of 18 months
Body temperature.
Time frame: through study completion, an average of 18 months
Number of Participants with Abnormal Laboratory Parameters Findings.
Time frame: through study completion, an average of 18 months
The number of research subjects who withdrew early.
Time frame: through study completion, an average of 18 months
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 14 Feb 2025.
- Individual participant dataSharing planned: No
Related trials for Bronchiolitis
Active, not recruiting
Respiratory Support and Treatment for Efficient and Cost-Effective Care
Bronchiolitis
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease
Not yet recruiting
Influence of Patient Positioning During Nasal Lavage
Acute Upper Respiratory Tract Infections, Nasal Obstruction
Active, not recruitingPhase 1/2
Alvelestat (MPH966), an Oral Neutrophil Elastase Inhibitor, in Bronchiolitis Obliterans Syndrome After Allogeneic Hematopoietic Stem Cell Transplantation
Chronic Graft vs Host Disease, Chronic Graft-Versus-Host Disease
Recruiting
Effect of Anomia Rehabilitation Combined With Metacognitive Training in Patients With Chronic Vascular Aphasia
Aphasia, Stroke
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.
Chuangli Hao, Ph.D principal investigator
Children's Hospital of Soochow University
Fanzheng Meng, Ph.D study director
The First Hospital of Jilin University
Xiaoxia Lu, Ph.D study director
Wuhan women and children's health care center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peginterferon α-2b injection and Recombinant Human Interferon α2b in people with Bronchiolitis, run by Children's Hospital of Soochow University at 3 sites in China.
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 7 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: looking for participants now, as of the sponsor's last update on 14 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
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 Chuangli Hao, Ph.D (13771905555, hcl_md@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of change in Wang's bronchiolitis score from baseline. (time frame: Day 6.). 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 14 Feb 2025; AzTrials last refreshed its copy on 8 Nov 2026.