Using oral prednisolone to treat wheezing in young children with rhinovirus
Official title: Oral Prednisolone for Acute Rhinovirus Induced Wheezing in Children Less Than 2 Years of Age: a Point-of-care Testing Guided Randomized, Double-blind, Placebo-controlled Trial
Run by University of Oulu · NCT05444699 · Data updated 2026-11-12
This study tests if giving young children with wheezing from a rhinovirus a medication called oral prednisolone can help them breathe better.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 6 Months to 24 Months |
| Sex | All |
| Enrollment | 210 (estimated) |
| Sponsor | University of Oulu Academic / other |
| Locations | 2 sites (Kokkola and 1 other locations) |
| Status | Recruiting |
| Started | October 11, 2022 |
| Main results expected | December 2026 |
| Study ends | September 2027 |
| Registry record updated | February 13, 2025 |
| Trial ID | NCT05444699 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are children aged 6 to 24 months diagnosed with wheezing bronchitis and requiring salbutamol treatment, with confirmed rhinovirus infection.
✕Probably not a fit
Patients who may not benefit include those with serious respiratory conditions requiring immediate resuscitation or those with other viral infections not caused by rhinovirus.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This trial evaluates the effectiveness of oral prednisolone in treating acute wheezing caused by rhinovirus in children aged 6 to 24 months. The treatment is guided by point-of-care testing to confirm the presence of rhinovirus. Participants will receive prednisolone sodium phosphate along with sugar syrup. The study aims to determine if this intervention can improve outcomes for young children experiencing wheezing bronchitis.
Why it matters
Potential benefit: If successful, this treatment could provide a more effective management option for young children suffering from wheezing due to rhinovirus infections.
How similar studies have gone: Other studies have explored corticosteroid use in respiratory conditions, but this specific approach using point-of-care testing for rhinovirus is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Wheezing bronchitis diagnosed by a physician * Need for salbutamol treatment at the emergency department * Positive nasopharyngeal rhinovirus or picornavirus finding in point-of-care testing Exclusion Criteria: * Need for immediate resuscitation * Immediate transfer to ICU * Suspected pneumonia based on the auscultation finding * Suspected serious bacterial infection * Other respiratory virus finding in the absence of rhinovirus or picornavirus * Positive respiratory syncytial virus finding * Positive SARS-coronavirus-2 finding * Positive Mycoplasma pneumoniae finding * Positive Bordetella pertussis finding * Contact with a person with chickenpox within 14 days * Active chickenpox * Suspected foreign body of the respiratory tract * Immunosuppressive treatment * Systemic corticosteroid treatment within 14 days * Allergy to corticosteroids
Where it's running
-
SOITE Lastenpäivystys
Kokkola, Finland Recruiting -
OYS Lastenpäivystys
Oulu, Finland Recruiting
Study contacts
- Study coordinator: Ville Lindholm, MD
- Email: Ville.a.lindholm@oulu.fi
- Phone: +35883155283
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.