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INnovative Steroid Treatment to reduce Asthma development in children after first-time Rhinovirus-induced wheezing
Trude Elvebakk1, Henrik Døllner2,3, Anna Partty4
1Children's Clinic, St Olav's Hospital HF, Trondheim, Norway trude.elvebakk@stolav.no.
Insights
This study investigated if short corticosteroid treatment prevents recurrent wheezing and asthma in young children with their first rhinovirus-induced episode. Findings may inform clinical guidelines for childhood asthma prevention.
Area of Science:
- Pediatrics
- Respiratory Medicine
- Clinical Trials
Background:
- Childhood asthma is a significant health concern, linked to early-life rhinovirus infections and wheezing.
- Identifying effective interventions for preventing recurrent wheezing and asthma in at-risk children is crucial.
Purpose of the Study:
- To evaluate the efficacy of a short course of oral dexamethasone in preventing recurrent wheezing and the development of asthma in infants and toddlers experiencing their first rhinovirus-induced wheezing episode.
Main Methods:
- A double-blind, randomized, placebo-controlled phase IV international multicenter trial involving 280 children aged 3-23 months.
- Participants received either oral dexamethasone or placebo for 3 days during their first rhinovirus-induced wheezing episode.
- Co-primary outcomes assessed were time to the next physician-confirmed wheezing episode and time to asthma diagnosis within 24 months.
Main Results:
- Results are pending dissemination.
- The study enrolled 280 steroid-naïve children diagnosed with rhinovirus-induced wheezing.
- Primary outcomes focus on preventing recurrent wheezing and asthma development.
Conclusions:
- The study aims to provide evidence for the effectiveness of early corticosteroid treatment in preventing childhood asthma.
- Findings could lead to updated pediatric clinical guidelines for managing early-life wheezing episodes.
Introduction:
Asthma is a leading cause of morbidity and healthcare use among children. Risk factors of childhood asthma include atopic predisposition and severe wheezing episodes caused by rhinovirus infection in early life. In children with first-time rhinovirus-induced wheezing, we aim to study the response of a short corticosteroid treatment to prevent recurrent wheezing and asthma.
Method And Analysis:
This is a double-blind, randomised, placebo-controlled, phase IV, international multicentre trial involving eight sites in Norway, Sweden and Finland. Two hundred and eighty 3-23 months old steroid-naïve children are randomised 1:1 to receive oral dexamethasone (0.3 mg/kg/day) versus placebo in 3 days for their first wheezing episode and rhinovirus infection. Rhinovirus is diagnosed with multiplex PCR. The two co-primary outcomes are time to next physician-confirmed wheezing episode, and time to asthma, within 24 months from inclusion. Asthma is defined as fulfilment of the 2007 National Asthma Education and Prevention Program-criteria for initiating asthma controller medication in children aged 0-4 years. Primary interaction analyses are age, gender, atopic predisposition, risk genotypes and viral co-detection. The optimal cut-off on the rhinovirus genome load used to define a true rhinovirus infection will be assessed by exploring interactions between rhinovirus genomic loads and study drug on the co-primary outcomes. Secondary outcomes are number of wheezing episodes, duration and severity of each wheezing episode, bronchial hyperreactivity, quality of life and safety (height/weight development) at 24 months from inclusion.
Ethics And Dissemination:
Rhinovirus positive children with acute wheezing fulfilling inclusion and exclusion criteria are enrolled after informed consent from both caregivers. This trial has received ethical approval from all sites. Results will be submitted to Competent Authorities and disseminated via peer-reviewed publications and conferences within paediatrics and other relevant fields. If proven effective, findings may be implemented directly into paediatric clinical guidelines.
Trial Registration Number:
NCT03889743.
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