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Taking people in SwedenPhase 4

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.

Key facts

Who runs it
St. Olavs Hospital
Where
Stockholm, SwedenSee the siteAlso in 2 other countries, 7 sites
Registry title
Innovative Steroid Treatment to Reduce Asthma Development in Children After First-time Rhinovirus Induced Wheezing
Status
Recruiting
Phase
Phase 4
People taking part
280 people, planned
Started
8 May 2019
Expected to end
May 2028
Type of study
Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • Dexamethasone treatment during 3 days
  • placebo treatment during 3 days
Record updated
20 July 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for babies and toddlers admitted to hospital with their first severe wheezing episode, caused by a rhinovirus infection.

Age
3 Months to 23 Months
Sex
Boys and girls can both join.
Disease stage
First-ever severe wheezing episode with breathing difficulty, starting less than 7 days before. At least one of: fever, low oxygen (SAT O2 <= 92%), retractions, prolonged expiration, or expiratory rhonchi.
Earlier treatment
The child cannot have had steroid treatment (by mouth, injection or inhaled) before.
Biomarker or test result
A PCR test of nasopharyngeal secretions must show a rhinovirus infection.

Main reasons for not taking part

  • Earlier wheezing episodes
  • Born before 37 weeks of pregnancy
  • Chronic illness other than atopy (eczema)
  • Needed intensive care during this infection, except non-invasive breathing support
  • Varicella (chickenpox) infection or contact in the last 2-3 weeks

The registry criteria, word for word

Show all 14 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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)

Where in Sweden

Also in 2 other countries, 7 sites

  • Karolinska UniversitetssjukhusetStockholm, SwedenContact: Jon Konradsen, md phdTaking people

About the trial

What the trial wants to find out

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

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.

The 2 groups in the trial

  • DexamethasoneTreatment being tested

    Treatment: Dexamethasone treatment during 3 days

  • controlsPlacebo, for comparison

    Treatment: placebo treatment during 3 days

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
Innovative Steroid Treatment to Reduce Asthma Development in Children After First-time Rhinovirus Induced Wheezing - the INSTAR Study
Plain-language title
Steroid Tested to Prevent Asthma After First Virus-Triggered Wheezing in Young ChildrenGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
20 July 2026