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

Study acronym: INSTAR
StatusRecruiting
PhasePhase 4
Started
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Record History

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  1. Re-verified, no change to tracked fieldsv13
  2. Primary completion date: May 2026 to May 2028
    • Start date: May 1, 2019 to May 8, 2019
    v12
  3. Re-verified, no change to tracked fieldsv11
  4. Primary completion date: May 2025 to May 2026
    • Study completion date: May 2025 to May 2028
    • Eligibility criteria shortened, about 17 words
    v10
  5. Re-verified, no change to tracked fieldsv9
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  1. Eligibility criteria expanded, about 27 wordsv8
  2. 2 versions Re-verified since Jun 14, 2021, no change to tracked fieldsv6-v7
  3. Primary and study completion dates: May 2023 to May 2025v5
  4. Study sites: 7 to 8
    • Secondary endpoints: 6 to 8
    • Collaborators: 6 to 7
    • Eligibility criteria expanded, about 1 word
    v4
  5. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of May 2019 to May 1, 2019
    • Site details revised at 7 of 7 sites
    v3
  6. Secondary endpoints revised (6)v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
St. Olavs Hospital
58 trials monitored
See 3 trials at risk
Asthma
956 trials monitored
See 34 trials at risk
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.
Trial Details
NCT Number NCT03889743
Lead Sponsor St. Olavs Hospital
Collaborators: Turku University Hospital, Karolinska University Hospital, Haukeland University Hospital, University Hospital, Akershus, Helse Stavanger HF, University Hospital of North Norway, Ullevaal University Hospital
Conditions
(from sponsor)		 Asthma, Inflammation
Related terms Asthma, Inflammation, Respiratory Sounds
Enrollment 280 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov