NCT03889743 Innovative Steroid Treatment to Reduce Asthma Development in Children After First-time Rhinovirus Induced Wheezing
| NCT ID | NCT03889743 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | St. Olavs Hospital |
| Condition | Asthma |
| Study Type | INTERVENTIONAL |
| Enrollment | 280 participants |
| Start Date | 2019-05-08 |
| Primary Completion | 2028-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 280 participants in total. It began in 2019-05-08 with a primary completion date of 2028-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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.
Contact & Investigator
Geir Bråthen
STUDY DIRECTOR
St. Olavs Hospital
Frequently Asked Questions
Who can join the NCT03889743 clinical trial?
This trial is open to participants of all sexes, aged 3 Months or older, up to 23 Months, studying Asthma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03889743 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT03889743 currently recruiting?
Yes, NCT03889743 is actively recruiting participants. Contact the research team at henrik.dollner@ntnu.no for enrollment information.
Where is the NCT03889743 trial being conducted?
This trial is being conducted at Turku, Finland, Bergen, Norway, Oslo, Norway, Oslo, Norway and 4 additional locations.
Who is sponsoring the NCT03889743 clinical trial?
NCT03889743 is sponsored by St. Olavs Hospital. The principal investigator is Geir Bråthen at St. Olavs Hospital. The trial plans to enroll 280 participants.
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