NCT03889743RecruitingPhase 4
Innovative Steroid Treatment to Reduce Asthma Development in Children After First-time Rhinovirus Induced Wheezing
Innovative Steroid Treatment to Reduce Asthma Development in Children After First-time Rhinovirus Induced Wheezing - the INSTAR Study
Source: ClinicalTrials.gov · Last updated 20 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 280 (estimated)
- First submitted
- 23 Mar 2019
- Start date
- 8 May 2019
- Primary completion date
- May 2028
- Lead sponsor
- St. Olavs Hospital
- Diseases
- Asthma
- NCT number
- NCT03889743
- EU CT number
- 2024-515350-25-01
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 280
- From 8 May 2019 to the primary completion date, May 2028
- 8 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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,
Other illness
- 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.
Age
- gestational age \<37 weeks
Other
- 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).
Who the study is looking for
- 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.
Age in the registry: 3 months to 23 months · Sex: All · Does not accept healthy volunteers
Sites (8)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Turku University Hospital Coordinator of this site? Confirm its status | Turku | Finland | Recruiting |
| Haukeland University Hospital Coordinator of this site? Confirm its status | Bergen | Norway | Recruiting |
| Akershus University Hospital Coordinator of this site? Confirm its status | Oslo | Norway | Recruiting |
| Ullevål University Hospital Coordinator of this site? Confirm its status | Oslo | Norway | Recruiting |
| Stavanger University Hospital Coordinator of this site? Confirm its status | Stavanger | Norway | Recruiting |
| University Hospital of North Norway Coordinator of this site? Confirm its status | Tromsø | Norway | Recruiting |
| St Olavs Hospital Coordinator of this site? Confirm its status | Trondheim | Norway | Recruiting |
| Karolinska Universitetssjukhuset Coordinator of this site? Confirm its status | Stockholm | Sweden | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.