RecruitingPhase 4NCT03889743

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

Sponsor

St. Olavs Hospital

Enrollment

280 participants

Start Date

May 8, 2019

Study Type

INTERVENTIONAL

Conditions

Asthma Inflammation

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

Min Age: 3 MonthsMax Age: 23 Months

Plain Language Summary

Simplified for easier understanding

This study is testing whether early treatment with inhaled steroids during a child's first severe wheezing episode caused by rhinovirus (the common cold virus) can prevent asthma from developing later in life. Rhinovirus-triggered wheezing in early childhood is strongly linked to future asthma development. **You may be eligible if...** - Your child is admitted to a participating pediatric hospital in Norway, Finland, or Sweden - This is your child's very first ever episode of severe wheezing or breathing difficulty - Symptoms started less than 7 days ago - Your child has tested positive for rhinovirus by PCR nasal test - Your child shows at least one sign of severity: fever, low blood oxygen, breathing retractions, wheezing on exam **You may NOT be eligible if...** - Your child has had any previous wheezing episode - Your child has a chronic lung or heart disease - Your child has already received oral steroids for this episode - Your child is less than 3 months old or weighs less than 5 kg Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDexamethasone 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.

DRUGplacebo 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.