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Innovative Steroid Treatment to Reduce Asthma Development in Children After First-time Rhinovirus Induced Wheezing

The overall objective of the study is to determine the efficacy of corticosteroids in preventing recurrent wheezing and asthma in high-risk, first-time severe wheezing children with rhinovirus infection, stratified by rhinovirus genome load. The secondary objectives are to determine duration and severity of each acute episode with acute expiratory breathing difficulty, the number of episodes with acute expiratory breathing difficulty, degree of pulmonary hyperreactivity and quality of life within 24 months after…

ClinicalTrials.gov IDNCT03889743

PhasePHASE4

Enrollment280

SponsorSt. Olavs Hospital

Age3 Months

SexALL

I'm interested View official listing

Conditions studied

Asthma, Inflammation

About this study

Interventions

Drug: Dexamethasone treatment during 3 days — Dexamethasone 1,0 mg oral tablets. The exact daily dose of dexamethasone will be 0.3 mg/kg (maximum 6.0 mg). The recommended administration of all tablets is to crush the tablets to a smooth powder and then mix with jelly or yogurt. The dissolved dexamethasone is given by mouth and it is recommended to give it in relation to a meal/breastfeeding. If a child vomits within 30 min, the same dose will be given one more time after a break.
Drug: placebo treatment during 3 days — 1,0 mg oral tablets. The exact daily dose of lactose (instead of dexamethasone) will be 0.3 mg/kg (maximum 6.0 mg). The recommended administration of all tablets is to crush the tablets to a smooth powder and then mix with jelly or yogurt. The dissolved dexamethasone is given by mouth and it is recommended to give it in relation to a meal/breastfeeding. If a child vomits within 30 min, the same dose will be given one more time after a break.

Primary outcomes

time to a new physician-confirmed wheezy episode within 24 months after study entry (24 months)
time to need for a regular controller medication for asthma within 24 months after study entry (24 months)

Eligibility information

Inclusion Criteria: * admitted to pediatric acute wards in the participating hospitals in Norway, Finland, Sweden. * referred for first severe wheezing episode, defined as first-time acute breathing difficulty with wheezing ever, appearing less than 7 days from onset of symptoms * one or more of the following:(a) fever, (b) hypoxia (SAT O2 \<= 92%), (c) retractions (inter-, subcostal), (d) prolonged expiration (on auscultation), (e) expiratory rhonchi (on auscultation) * evidence of rhinovirus infection by PCR-test in nasopharyngeal secretions * signed informed consent and expected cooperation of the patients for the treatment and follow-up must be obtained and documented according to ICH GCP, and national/local regulations. Exclusion Criteria: * previous episodes with wheezing, defined as a history of acute breathing difficulty with wheezing in need of treatment at a general practitioner or at hospital, or parental information about similar breathing difficulties * gestational age \<37 weeks * chronic illness other than atopy (eczema), * previous systemic or inhaled corticosteroid treatment, * participation to another trial, * varicella infection or contact during the last 2-3 weeks, * need for intensive care unit treatment during the present infection, except for respiratory support with non-invasive methods (high flow nasal cannula ventilation, CPAP or BiPAP), * any reason why, in the opinion of the investigator, the patient should not participate (e.g. not able to comply with study procedures). * COVID-19 related disease.

Study locations

Turku University Hospital, Turku, Finland
Haukeland University Hospital, Bergen, Norway
Akershus University Hospital, Oslo, Norway
Ullevål University Hospital, Oslo, Norway
Stavanger University Hospital, Stavanger, Norway
University Hospital of North Norway, Tromsø, Norway
St Olavs Hospital, Trondheim, Norway
Karolinska Universitetssjukhuset, Stockholm, Sweden

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.