Corticosteroid treatment to prevent asthma in children after wheezing from rhinovirus

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Study coordinator: Henrik Døllner, md phd
• Email: henrik.dollner@ntnu.no
• Phone: 0047 73559531

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.