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

University of Oulu

Status and phase: Enrolling; Phase 4

Conditions: Bronchiolitis Acute Viral

Treatments: Drug: Prednisolone Sodium Phosphate; Drug: Sugar syrup

Study type: Interventional

Funder types: Other

Identifiers

NCT05444699

OY102021

2021-006050-31 (EudraCT Number)

2024-512561-13-00 (EU Trial (CTIS) Number)

Details and patient eligibility

About

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.

Enrollment: 210 estimated patients

Sex: All

Ages: 6 to 24 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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210 participants in 2 patient groups, including a placebo group

Prednisolone

Experimental group

Description:

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)

Treatment:

Drug: Prednisolone Sodium Phosphate

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Sugar syrup