Oral Prednisolone for Acute Rhinovirus Induced Wheezing in Children Less Than 2 Years of Age (RhinoPOCRCT)

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.

Study Overview

• Status: Recruiting
• Conditions: Bronchiolitis Acute Viral
• Intervention / Treatment: Drug: Prednisolone Sodium Phosphate; Drug: Sugar syrup

• Study Type: Interventional
• Enrollment (Estimated): 210
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Ville Lindholm, MD; Phone Number: +35883155283; Email: Ville.a.lindholm@oulu.fi

Study Locations

• Finland
  • Kokkola, Finland
    • Recruiting
    • SOITE Lastenpäivystys
    • Contact: Nelli Korpela, M.D., PhD; Email: nelli.korpela@oulu.fi
  • Oulu, Finland, 90130
    • Recruiting
    • OYS Lastenpäivystys
    • Contact: Terhi Tapiainen, MD, PhD; Phone Number: +358-8-315 5185; Email: terhi.tapiainen@oulu.fi
    • Principal Investigator: Terhi Tapiainen, MD, PhD
    • Sub-Investigator: Niko Paalanne, MD, PhD
    • Sub-Investigator: Kimmo Halt, MD
    • Sub-Investigator: Tytti Pokka, MSc
    • Sub-Investigator: Ulla Koskela, MD, PhD
    • Sub-Investigator: Ville Lindholm, MD
    • Sub-Investigator: Minna Honkila, MD, PhD
    • Sub-Investigator: Tuomas Jartti, MD, PhD
    • Contact: Ville Lindholm, MD; Phone Number: +35883155283; Email: Ville.a.lindholm@oulu.fi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 2 years (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Prednisolone; 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)	Drug: Prednisolone Sodium Phosphate; Oral suspension administered 1 mg/kg once a day for three days
Placebo Comparator: Placebo; 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.	Drug: Sugar syrup; Oral suspension administered the same amount in milliliters as experimental product once a day for three days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Within 7 days of study entry

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total length of hospital stay	The difference (in minutes) between the study entry and the actual time of discharge from the hospital	Within 7 days of study entry
Intensive care unit (ICU) admissions	Proportion of children admitted to ICU	Within 7 days of study entry
Supplemental oxygen	The total duration (in minutes) of the need for supplemental oxygen	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.	Within 7 days of study entry
Recurrence of wheezing	Proportion of patients with recurrence of wheezing after initial episode	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	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	At 14 days of study entry
Duration of cough	Mean duration (in days) of cough without relapse for 3 days	Within 28 days of study entry
Duration of cough	Mean duration (in days) of cough without relapse for 3 days	Within 14 days of study entry
Duration of salbutamol use	Mean number of days in which salbutamol is used	Within 14 days of study entry
Duration of respiratory distress	Mean duration (in days) of respiratory distress without relapse for 3 days	Within 14 days of study entry
Deaths	Proportion of patients who died of any cause	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	Within 12 months of study entry
Recurrence of wheezing (time)	Time (in days) to recurrence of wheezing diagnosed by a physician	Within 12 months of study entry
Daily administrated asthma medication	Time (in days) to prescription of daily administrated asthma medication	Within 24 months of study entry
Antibiotics and asthma medications	Purchases of antibiotics and asthma medications	Within 24 months of study entry

Collaborators and Investigators

• Sponsor: University of Oulu

Study record dates

Study Major Dates

• Study Start (Actual): October 11, 2022
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: December 22, 2021
• First Submitted That Met QC Criteria: July 5, 2022
• First Posted (Actual): July 6, 2022

Study Record Updates

• Last Update Posted (Actual): January 19, 2024
• Last Update Submitted That Met QC Criteria: January 18, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Signs and Symptoms, Respiratory; Lung Diseases, Obstructive; Bronchitis; Bronchiolitis; Respiratory Sounds; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Neuroprotective Agents; Protective Agents; Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
• Other Study ID Numbers: OY102021; 2021-006050-31 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No