Efficacy of Systemic Glucocorticoid in the Treatment of Wheezing in Children

Summary

We can not predict which wheezing child younger than 3 years of age benefits from systemic glucocorticoid and which one does not. It is not known whether the differences in the efficacy are related to the differences in viral etiology, atopy, immunogical maturity or age of the patient. The study aims to answer the following questions: 1. What is the viral etiology of acute childhood expiratory wheezing? 2. What is the efficacy of prednisolone in relation to age, atopy and viral etiology in acute childhood wheezing? 3. Does prednisolone treatment increase risk for secundary bacterial infection in acute childhood expiratory wheezing? 4. What is the significance of inflammatory markers in predicting the efficacy of systemic steroid or patient outcome in acute childhood expiratory wheezing? Study will follow randomized, double blind, placebo-controlled parallel design. Study will start in Septemper 2000 and will be performed at the Department of Pediatrics, Turku University Hospital, Turku Finland. The study population will be 300 hospitalized wheezing children aged 3 months - 15 years. Investigational drug will be prednisolone, first dose 2 mg/kg, then 2 mg/kg/d/3 (max. 60 mg/vrk) p.o. for 3 d and comparative drug will be placebo tablet similar to investigational drug with the equal dosage. The primary outcome will be the time until ready for discharge. The study will provide new and important information for the diagnostics, treatment, disease outcome and prevention of acute childhood expiratory wheezing.

Timeline

Start

2000-09

Primary completion

—

Completion

2008-05

Publications

• Forsstrom V, Toivonen L, Homil K, Waris M, Pedersen CT, Bonnelykke K, Jartti T, Peltola V. Association of Asthma Risk Alleles With Acute Respiratory Tract Infections and Wheezing Illnesses in Young Children. J Infect Dis. 2023 Oct 18;228(8):990-998. doi: 10.1093/infdis/jiad075.
• Hurme P, Homil K, Lehtinen P, Turunen R, Vahlberg T, Vuorinen T, Camargo CA Jr, Gern JE, Jartti T. Efficacy of inhaled salbutamol with and without prednisolone for first acute rhinovirus-induced wheezing episode. Clin Exp Allergy. 2021 Sep;51(9):1121-1132. doi: 10.1111/cea.13960. Epub 2021 Jun 19.
• Lukkarinen M, Koistinen A, Turunen R, Lehtinen P, Vuorinen T, Jartti T. Rhinovirus-induced first wheezing episode predicts atopic but not nonatopic asthma at school age. J Allergy Clin Immunol. 2017 Oct;140(4):988-995. doi: 10.1016/j.jaci.2016.12.991. Epub 2017 Mar 25.
• Lukkarinen M, Lukkarinen H, Lehtinen P, Vuorinen T, Ruuskanen O, Jartti T. Prednisolone reduces recurrent wheezing after first rhinovirus wheeze: a 7-year follow-up. Pediatr Allergy Immunol. 2013 May;24(3):237-43. doi: 10.1111/pai.12046. Epub 2013 Feb 3.

Drugs

Indications