Innovative Steroid Treatment to Reduce Asthma Development in Children After First-time Rhinovirus Induced Wheezing

Launched by ST. OLAVS HOSPITAL · Mar 23, 2019

Keywords

ClinConnect Summary

This clinical trial is studying whether a type of medication called corticosteroids can help prevent asthma and repeated wheezing episodes in young children who have just experienced their first severe wheezing episode due to a rhinovirus infection, which is a common cold virus. Researchers want to see how effective this treatment is, especially in children who are at higher risk for asthma. They will also look at how long these breathing difficulties last, how severe they are, and how they affect the child’s overall quality of life over the next two years.

To be part of this study, children must be between 3 months and 2 years old, and they need to have been hospitalized for their first serious wheezing episode, which means they have had trouble breathing and wheezing symptoms that started within the last week. They also need to show signs of a rhinovirus infection through a test. It’s important to know that children who have had previous wheezing episodes or certain other health issues will not be eligible to participate. Families who join can expect regular follow-ups to monitor their child’s health and response to the treatment. This study is currently recruiting participants in Norway, Finland, and Sweden.

Gender

ALL

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.