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

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-515350-25-01
Enrollment
280
Registered
2025-01-23
Start date
2019-04-12
Completion date
Unknown
Last updated
2025-01-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute wheezing/bronchiolitis

Brief summary

Primary endpoints are 1) the time to a new physician-confirmed wheezy episode, and 2) time to fullfill astma criteria defined as need for a regular controller medication for asthma within 24 months after study entry.

Detailed description

1) Determined at the first episode of acute breathing difficulty within 24 months of study entry: a) duration and severity of symptoms. 2) Determined at each scheduled follow-up visit within 24 months of study entry: a) number, duration and severity of episodes with acute breathing difficulty since start of study medication, b) degree of pulmonary hyperreactivity, c) quality of life, d) height and weight

Interventions

DRUGPlacebo tablets identical to dexamethasone Abcur 1.0 mg tablets
DRUGDEXAMETHASONE

Sponsors

St. Olavs Hospital HF
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
0 Years to 17 Years

Design outcomes

Primary

MeasureTime frame
Primary endpoints are 1) the time to a new physician-confirmed wheezy episode, and 2) time to fullfill astma criteria defined as need for a regular controller medication for asthma within 24 months after study entry.

Secondary

MeasureTime frame
1) Determined at the first episode of acute breathing difficulty within 24 months of study entry: a) duration and severity of symptoms. 2) Determined at each scheduled follow-up visit within 24 months of study entry: a) number, duration and severity of episodes with acute breathing difficulty since start of study medication, b) degree of pulmonary hyperreactivity, c) quality of life, d) height and weight

Countries

Finland, Norway, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026