Bronchiolitis Acute ViralPhase 4RhinoPOCRCTNCT05444699
Oral Prednisolone for Acute Rhinovirus Induced Wheezing in Children Less Than 2 Years of Age
A Phase 4 study testing Prednisolone Sodium Phosphate and Sugar syrup in people with Bronchiolitis Acute Viral, run by University of Oulu at 2 sites in Finland.
Trial summary
The aim of the trial is to evaluate whether the use of oral prednisolone directed by point-of-care testing is useful in acute wheezing caused by rhinovirus in children aged 6-24 months. Read more about this study
- Who is it for?
- Ages 6 to 24 months
- Conditions the study is for
- Bronchiolitis Acute Viral
- What is being tested?
- Prednisolone Sodium Phosphate and Sugar syrup
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 210 participants
- Where
- 2 sitesFinland
- Study dates
- 11 Oct 2022to Sep 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 6 to 24 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Finland2 sites, 2 recruiting
- Recruiting
SOITE Lastenpäivystys
Kokkola
Nelli Korpela, M.D., PhD, nelli.korpela@oulu.fi
- Recruiting
OYS Lastenpäivystys
Oulu, 90130
Ville Lindholm, MD, +35883155283, Ville.a.lindholm@oulu.fi
Terhi Tapiainen, MD, PhD, +358-8-315 5185, terhi.tapiainen@oulu.fi
About this study
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
The aim of the trial is to evaluate whether the use of oral prednisolone directed by point-of-care testing is useful in acute wheezing caused by rhinovirus in children aged 6-24 months.
- Conditions
- Bronchiolitis Acute Viral
- Being tested
- Prednisolone Sodium Phosphate, Sugar syrup
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prednisolone Sodium PhosphateDrug
Oral suspension administered 1 mg/kg once a day for three days
Sugar syrupDrug
Oral suspension administered the same amount in milliliters as experimental product once a day for three days
| Study group | Role | What they receive |
|---|---|---|
| Prednisolone | Experimental | Prednisolone Sodium Phosphate (25 mg/5 mL) oral suspension administered 1 mg/kg* (up to 20 mg = 4 mL) once a day for 3 days.
*(0-5 kg: 5 mg; 5.01-7.5 kg: 7.5 mg; 7.51-10 kg: 10 mg; 10.01-12.5 kg: 12.5 mg; 12.51-15 kg: 15 mg; 15.01-17.5 kg: 17.5 mg; ≥ 17.51 kg: 20 mg) Receives: Drug: Prednisolone Sodium Phosphate |
| Placebo | Placebo comparator | Sugar syrup oral suspension containing saccharum 630-640 mg/g and aqua purificata 360-370 mg/g administered the same amount in milliliters as experimental product (up to 4 mL) once a day for 3 days. Receives: Drug: Sugar syrup |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of hospital stay
The difference (in minutes) between the study entry and the time that the patient is deemed to be fit for discharge (sign off for discharge)
Subgroup analyses for the primary outcome are performed in following subgroups:
- Children presenting with first episode of wheezing
- Children with at least one previous episode of wheezing diagnosed by a physician
- Children with a cycle threshold number of < 30 for detected picornavirus
- Children with a cycle threshold number of 30-37 for detected picornavirus
- Children with a cycle threshold number of 38-40 for detected picornavirus
Measured: Within 7 days of study entry
Secondary outcomes (16)
Total length of hospital stay
The difference (in minutes) between the study entry and the actual time of discharge from the hospital
Measured: Within 7 days of study entry
Intensive care unit (ICU) admissions
Proportion of children admitted to ICU
Measured: Within 7 days of study entry
Supplemental oxygen
The total duration (in minutes) of the need for supplemental oxygen
Measured: Within 7 days of study entry
Pediatric Early Warning Signs (PEWS) score
Maximum decrease in PEWS score within 12 hours after study entry. PEWS scores range from 0 to 32 depending on the child's respiratory rate, work of breathing, saturation of peripheral oxygen, need for supplemental oxygen, blood pressure, heart rate, capillary refill and level of consciousness. 0 refers to low and > 7 to high risk of deterioration.
Measured: Within 7 days of study entry
Recurrence of wheezing
Proportion of patients with recurrence of wheezing after initial episode
Measured: Within 56 days of study entry
Hospital re-admission
Proportion of patients with re-admission to hospital or visit to emergency department after discharge from the hospital
Measured: Within 14 days of study entry
Proportion of patients with cough at 14 days of study entry
Proportion of patients with cough at 14 days of study entry
Measured: At 14 days of study entry
Duration of cough
Mean duration (in days) of cough without relapse for 3 days
Measured: Within 28 days of study entry
Duration of cough
Mean duration (in days) of cough without relapse for 3 days
Measured: Within 14 days of study entry
Duration of salbutamol use
Mean number of days in which salbutamol is used
Measured: Within 14 days of study entry
Duration of respiratory distress
Mean duration (in days) of respiratory distress without relapse for 3 days
Measured: Within 14 days of study entry
Deaths
Proportion of patients who died of any cause
Measured: Within 30 of study entry
Recurrence of wheezing (proportion)
Proportion of patients with recurrence of wheezing diagnosed by a physician at 2 and 12 months of study entry
Measured: Within 12 months of study entry
Recurrence of wheezing (time)
Time (in days) to recurrence of wheezing diagnosed by a physician
Measured: Within 12 months of study entry
Daily administrated asthma medication
Time (in days) to prescription of daily administrated asthma medication
Measured: Within 24 months of study entry
Antibiotics and asthma medications
Purchases of antibiotics and asthma medications
Measured: Within 24 months of study entry
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2022
- Study start11 Oct 2022
- Primary completionDec 2026 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchiolitis Acute ViralStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oulu
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Terhi Tapiainen, University of Oulu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05444699
- Sponsor's protocol ID
- OY102021
- Other IDs
- 2024-512561-13-00, 2021-006050-31
- Acronym
- RhinoPOCRCT
- Status last verified
- Feb 2025
- First submitted
- 22 Dec 2021
- Last updated
- 13 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 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05444699
- Acronym / sponsor ID
- RhinoPOCRCT / OY102021
- Conditions
- Bronchiolitis Acute Viral
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- University of OuluUniversity, hospital or other
- Study start
- 11 Oct 2022 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 6 Jul 2022 (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.
The aim of the trial is to evaluate whether the use of oral prednisolone directed by point-of-care testing is useful in acute wheezing caused by rhinovirus in children aged 6-24 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prednisolone | Experimental | Drug: Prednisolone Sodium PhosphatePrednisolone Sodium Phosphate (25 mg/5 mL) oral suspension administered 1 mg/kg* (up to 20 mg = 4 mL) once a day for 3 days. *(0-5 kg: 5 mg; 5.01-7.5 kg: 7.5 mg; 7.51-10 kg: 10 mg; 10.01-12.5 kg: 12.5 mg; 12.51-15 kg: 15 mg; 15.01-17.5 kg: 17.5 mg; ≥ 17.51 kg: 20 mg) |
| Placebo | Placebo comparator | Drug: Sugar syrupSugar syrup oral suspension containing saccharum 630-640 mg/g and aqua purificata 360-370 mg/g administered the same amount in milliliters as experimental product (up to 4 mL) once a day for 3 days. |
Who may qualify
- Ages
- 6 to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (15 listed)
- 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
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 |
|---|---|---|
| Prednisolone Sodium PhosphateOral suspension administered 1 mg/kg once a day for three days | Drug | Prednisolone |
| Sugar syrupOral suspension administered the same amount in milliliters as experimental product once a day for three days | Drug | Placebo |
Primary outcome
Length of hospital stay
Time frame: Within 7 days of study entry
The difference (in minutes) between the study entry and the time that the patient is deemed to be fit for discharge (sign off for discharge) Subgroup analyses for the primary outcome are performed in following subgroups: * Children presenting with first episode of wheezing * Children with at least one previous episode of wheezing diagnosed by a physician * Children with a cycle threshold number of < 30 for detected picornavirus * Children with a cycle threshold number of 30-37 for detected picornavirus * Children with a cycle threshold number of 38-40 for detected picornavirus
16 secondary outcomes
Total length of hospital stay
Time frame: Within 7 days of study entry
Intensive care unit (ICU) admissions
Time frame: Within 7 days of study entry
Supplemental oxygen
Time frame: Within 7 days of study entry
Pediatric Early Warning Signs (PEWS) score
Time frame: Within 7 days of study entry
Recurrence of wheezing
Time frame: Within 56 days of study entry
Hospital re-admission
Time frame: Within 14 days of study entry
Proportion of patients with cough at 14 days of study entry
Time frame: At 14 days of study entry
Duration of cough
Time frame: Within 28 days of study entry
Duration of cough
Time frame: Within 14 days of study entry
Duration of salbutamol use
Time frame: Within 14 days of study entry
Duration of respiratory distress
Time frame: Within 14 days of study entry
Deaths
Time frame: Within 30 of study entry
Recurrence of wheezing (proportion)
Time frame: Within 12 months of study entry
Recurrence of wheezing (time)
Time frame: Within 12 months of study entry
Daily administrated asthma medication
Time frame: Within 24 months of study entry
Antibiotics and asthma medications
Time frame: Within 24 months of study entry
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 13 Feb 2025.
- Individual participant dataSharing planned: No
Related trials for Bronchiolitis Acute Viral
Recruiting
Respiratory Physiotherapy and Hospitalization in Infants With Bronchiolitis
Acute Viral Bronchiolitis
Not yet recruitingObservational study
Internal Jugular Vein Respiratory Variability as a Marker of Disease Severity in Infant Bronchiolitis
Acute Bronchiolitis, Viral Bronchiolitis
Active, not recruitingObservational study
Effectiveness of Immunization in Preventing Severe Acute Respiratory Infection RSV in Children Under 6 Months in Bogotá
Respiratory Syncytial Virus Infections, Severe Acute Respiratory Infection
Not yet recruitingObservational study
Risk Factors and Severity of Bronchiolitis in Hospitalized Children at Assiut University Hospital
Bronchiolitis, Acute Bronchiolitis
Not yet recruitingObservational study
Gut Microbiome and Immune Response in Severe RSV Infection in Vietnamese Infants
Respiratory Syncytial Virus Infection, Bronchiolitis
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Prednisolone Sodium Phosphate and Sugar syrup in people with Bronchiolitis Acute Viral, run by University of Oulu at 2 sites in Finland.
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 3 inclusion and 15 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 13 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 2 sites in Finland. 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. Some participants in this study may receive a placebo. 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 Ville Lindholm, MD (+35883155283, Ville.a.lindholm@oulu.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of hospital stay (time frame: Within 7 days of study entry). 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 13 Feb 2025.