NCT03889743|RecruitingPhase 4DMC
Innovative Steroid Treatment to Reduce Asthma Development in Children After First-time Rhinovirus Induced Wheezing
INSTAR
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Sponsor study identifier
Secondary identifiers
CTIS
interventional
280
3 countries
8
Study Start
May 8, 2019
Actual (reported)Primary Completion
May 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
May 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 23, 2019
Actual (reported)March 26, 2019
Actual (reported)May 8, 2019
Actual (reported)May 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
May 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
duration of respiratory symptoms
24 months
severity of respiratory symptoms
24 months
the number of episodes with acute breathing difficulty since start of study medication
24 months
the duration of episodes with acute breathing difficulty since start of study medication
24 months
the degree of pulmonary hyperreactivity
24 months
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.
Turku University Hospital
Turku, Finland
Haukeland University Hospital
Bergen, Norway
Akershus University Hospital
Oslo, Norway
Elvebakk T, Dollner H, Partty A, Jartti H, Vuorinen T, Oymar K, Nerheim S, Moe N, Nordbo SA, Follestad T, Koski J, Vollsaeter M, Hofstad A, Klingenberg C, Leknessund CB, Skjerven HO, Risnes K, Soderhall C, Sissener E, Inchley CS, Konradsen JR, Jartti T. INnovative Steroid Treatment to reduce Asthma development in children after first-time Rhinovirus-induced wheezing (INSTAR): protocol for a randomised placebo-controlled trial. BMJ Open. 2025 Jul 30;15(7):e103530. doi: 10.1136/bmjopen-2025-103530.
Geir Bråthen
St. Olavs Hospital
First Submitted
March 23, 2019
First Posted
March 26, 2019
Study Start
May 8, 2019
Actual (reported)High-Dose Steroid for Knee Arthroplasty
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Ullevål University Hospital
Oslo, Norway
Stavanger University Hospital
Stavanger, Norway
University Hospital of North Norway
Tromsø, Norway
St Olavs Hospital
Trondheim, Norway
Karolinska Universitetssjukhuset
Stockholm, Sweden
Primary Completion
May 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
May 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
July 20, 2026
Record last verified: 2026-07
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