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

NCT03889743 · tracked via the Priya Life Science Sweden tracker

Sponsor

St. Olavs Hospital

Phase

Phase 4

Started

2019-05-08

Last updated

2026-07-20

Condition(s) studied

AsthmaInflammation

Investigational drug(s) / intervention(s)

Dexamethasone treatment during 3 daysplacebo treatment during 3 days

Dexamethasone treatment during 3 days: Dexamethasone 1,0 mg oral tablets. The exact daily dose of dexamethasone will be 0.3 mg/kg (maximum 6.0 mg). The recommended administration of all tablets is to crush the tablets to a smooth powder and then mix with jelly or yogurt. The dissolved dexamethasone is given by mouth and it is recommended to give it in relation to a meal/breastfeeding. If a child vomits within 30 min, the same dose will be given one more time after a break.

placebo treatment during 3 days: 1,0 mg oral tablets. The exact daily dose of lactose (instead of dexamethasone) will be 0.3 mg/kg (maximum 6.0 mg). The recommended administration of all tablets is to crush the tablets to a smooth powder and then mix with jelly or yogurt. The dissolved dexamethasone is given by mouth and it is recommended to give it in relation to a meal/breastfeeding. If a child vomits within 30 min, the same dose will be given one more time after a break.

Study 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

Sex

ALL

Min age

3 Months

Max age

23 Months

Healthy volunteers

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.

Primary outcome measure(s)

time to a new physician-confirmed wheezy episode within 24 months after study entry — 24 months
time to need for a regular controller medication for asthma within 24 months after study entry — 24 months

Trial sites (8)

Facility	City	Region	Status
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

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03889743 on ClinicalTrials.gov ↗ ← All trials in Sweden