Corticosteroid treatment to prevent asthma in children after wheezing from rhinovirus
Innovative Steroid Treatment to Reduce Asthma Development in Children After First-time Rhinovirus Induced Wheezing - the INSTAR Study
This study is testing if giving dexamethasone, a type of corticosteroid, can help prevent asthma and reduce wheezing in children after they have a severe wheezing episode caused by a rhinovirus infection.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 280 (estimated) |
| Ages | 3 Months to 23 Months |
| Sex | All |
| Sponsor | St. Olavs Hospital Academic / other |
| Locations | 8 sites (Turku and 7 other locations) |
| Trial ID | NCT03889743 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of corticosteroids, specifically dexamethasone, in preventing recurrent wheezing and asthma in children who experience their first severe wheezing episode due to rhinovirus infection. The study will assess the impact of treatment on the duration and severity of wheezing episodes, pulmonary hyperreactivity, and quality of life over a 24-month period. Participants will be children admitted to pediatric wards in Norway, Finland, and Sweden, who have tested positive for rhinovirus and meet specific clinical criteria. The study will compare the outcomes of those receiving dexamethasone versus a placebo.
Who should consider this trial
Good fit: Ideal candidates are children experiencing their first severe wheezing episode due to rhinovirus infection, admitted to pediatric acute wards.
Not a fit: Patients with a history of previous wheezing episodes or those who do not meet the inclusion criteria will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the incidence of asthma development in high-risk children following rhinovirus infections.
How similar studies have performed: Other studies have indicated that targeting rhinovirus infections may be a promising approach to asthma prevention, but this specific intervention with corticosteroids is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Turku and 7 other locations
- Turku University Hospital — Turku, Finland (Recruiting)
- Haukeland University Hospital — Bergen, Norway (Recruiting)
- Akershus University Hospital — Oslo, Norway (Recruiting)
- Ullevål University Hospital — Oslo, Norway (Recruiting)
- Stavanger University Hospital — Stavanger, Norway (Recruiting)
- University Hospital of North Norway — Tromsø, Norway (Recruiting)
- St Olavs Hospital — Trondheim, Norway (Recruiting)
- Karolinska Universitetssjukhuset — Stockholm, Sweden (Recruiting)
Study contacts
- Study coordinator: Henrik Døllner, md phd
- Email: henrik.dollner@ntnu.no
- Phone: 0047 73559531
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.