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INnovative Steroid Treatment to reduce Asthma development in children after first-time Rhinovirus-induced wheezing (INSTAR): protocol for a randomised placebo-controlled trial
Tekijät: Elvebakk, Trude; Døllner, Henrik; Pärtty, Anna; Jartti, Heidi; Vuorinen, Tytti; Øymar, Knut; Nerheim, Silje; Moe, Nina; Nørdbo, Svein Arne; Follestad, Turid; Koski, Johanna; Vollsæter, Maria; Hofstad, Anita; Klingenberg, Claus; Leknessund, Carina Bjørkvoll; Skjerven, Håvard Ove; Risnes, Kari; Söderhäll, Cilla; Sissener, Erle; Inchley, Christopher Stephen; Konradsen, Jon R.; Jartti, Tuomas
Kustantaja: BMJ PUBLISHING GROUP
Kustannuspaikka: LONDON
Julkaisuvuosi: 2025
Journal: BMJ Open
Lehden akronyymi: BMJ OPEN
Artikkelin numero: e103530
Vuosikerta: 15
Numero: 7
Sivujen määrä: 9
eISSN: 2044-6055
DOI: https://doi.org/10.1136/bmjopen-2025-103530
Verkko-osoite: https://bmjopen.bmj.com/content/15/7/e103530
Rinnakkaistallenteen osoite: https://research.utu.fi/converis/portal/detail/Publication/499719197
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-na & iuml;ve 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.
Ladattava julkaisu This is an electronic reprint of the original article. |  |
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Norwegian funding is sponsored by the National programme for clinical therapy research in the specialist health service, KLINBEFORSK, http://kliniskforskning.rhf-forsk.org/utlysning/utlysning/call-in-english/. KLINBEFORSK does not use grant numbers. The funds are assigned St. Olavs hospital HF, Trondheim University Hospital, by project manager and National Coordinating Investigator (NCI) in Norway, Henrik Døllner. Finnish funding is sponsored by Sigrid Juselius Foundation, Helsinki, Foundation for Pediatric Research, Helsinki, Paulo Foundation, Helsinki, Tampere Tuberculosis Foundation, Tampere, Päivikki and Sakari Sohlberg Foundation, Helsinki, and Allergy Research Foundation, Helsinki. None of the funding bodies have grant numbers. The funds are assigned to Turku University Hospital by NCI in Finland, Tuomas Jartti. Swedish funding is sponsored by the Stockholm County Council-Region Stockholm (FoUI-954328), the Swedish Heart and Lung Foundation (2019-0521), the Konsul Th C Berghs Foundation (k62210053), the Swedish Asthma and Allergy Association’s Research Foundation (f2021-0035) and the Åke Wibergs Foundation (K62210093). The funds are assigned Astrid Lindgren Children’s Hospital, Karolinska University Hospital, by NCI in Sweden, Jon R. Konradsen.
