Steroid Tested to Prevent Asthma After First Virus-Triggered Wheezing in Young Children
Tests dexamethasone against placebo in infants with a first rhinovirus-triggered wheezing episode.
Plain-language title generated from the registry record
Registry title: Innovative Steroid Treatment to Reduce Asthma Development in Children After First-time Rhinovirus Induced Wheezing
Key facts
- Where
- Bergen, Oslo, Stavanger, Tromsø, and Trondheim, NorwaySee the 6 sites
- Phase
- Phase 4
Where in Norway
- Haukeland University HospitalBergen, NorwayTaking people
- Akershus University HospitalOslo, NorwayTaking people
- Ullevål University HospitalOslo, NorwayTaking people
- Stavanger University HospitalStavanger, NorwayTaking people
- University Hospital of North NorwayTromsø, NorwayTaking people
- St Olavs HospitalTrondheim, NorwayTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- St. Olavs Hospital
- Trial code
- NCT03889743EU 2024-515350-25-01
- Record updated
- 20 July 2026
- Original description
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.Read full original descriptionShow less
Innovative Steroid Treatment to Reduce Asthma Development in Children After First-time Rhinovirus Induced Wheezing - the INSTAR Study
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 study entry.
Inclusion: 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: 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; previous systemic or inhaled corticosteroid treatment,; chronic illness other than atopy (eczema),; 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),; COVID-19 related disease; gestational age <37 weeks; participation to another trial,; any reason why, in the opinion of the investigator, the patient should not participate (e.g. not able to comply with study procedures).