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Preventing Asthma in High Risk Kids

Study acronym: PARK
StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

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  1. 3 versions Re-verified since Oct 8, 2024, no change to tracked fieldsv31-v33
  2. Primary completion date: Nov 27, 2025 to Jan 31, 2028
    • Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: Nov 27, 2027 to Mar 31, 2028
    • Site details revised at 13 of 13 sites
    v30
  3. Primary completion date: Nov 27, 2023 to Nov 27, 2025
    • Study completion date: Nov 27, 2025 to Nov 27, 2027
    v29
  4. Site contacts updated at 3 of 13 sitesv28
  5. Enrollment target: 250 to 200
    • Eligibility criteria shortened, about 10 words
    • Site contacts updated at 2 of 13 sites
    v27
Show 25 earlier versionsHide 25 earlier versions
  1. Site contacts updated at 8 of 13 sitesv26
  2. Study sites: 14 to 13v25
  3. Site details revised at 1 of 14 sitesv24
  4. Site details revised at 2 of 14 sitesv23
  5. Study sites: 12 to 14
    • Eligibility criteria expanded, about 38 words
    v22
  6. Site details revised at 1 of 12 sitesv21
  7. Site details revised at 1 of 12 sitesv20
  8. Site details revised at 1 of 12 sitesv19
  9. Study sites: 10 to 12v18
  10. Study sites: 9 to 10v17
  11. Study sites: 8 to 9v16
  12. Lead sponsor: Wanda Phipatanakul to Boston Children's Hospital
    • Collaborators expanded, about 8 words
    v15
  13. Study sites revised (8)v14
  14. Site details revised at 2 of 8 sitesv13
  15. Site details revised at 1 of 8 sitesv12
  16. Study sites: 9 to 8v11
  17. Trial status: Not Yet Recruiting to Recruiting
    • Primary completion date: Nov 2023 to Nov 27, 2023
    • Study completion date: Nov 2025 to Nov 27, 2025
    • Site details revised at 9 of 9 sites
    v10
  18. Start date: Sep 30, 2018 to Nov 27, 2018
    • Study sites: 10 to 9
    • Primary completion date: Sep 2023 to Nov 2023
    • Study completion date: Sep 2024 to Nov 2025
    v9
  19. Start date: May 30, 2018 to Sep 30, 2018v8
  20. Phase: Phase 3 to Phase 2
    • Start date: Mar 30, 2018 to May 30, 2018
    • Eligibility criteria expanded, about 368 words
    • Secondary endpoints: 5 to 2
    v7
  21. 2 versions Re-verified since Nov 1, 2017, no change to tracked fieldsv5-v6
  22. Start date: Sep 2016 to Mar 30, 2018v4 Show 4 more changesShow less
    • Primary endpoints: 1 to 2
    • Study sites: 5 to 10
    • Eligibility criteria revised
    • Study title shortened, about 3 words
  23. Re-verified, no change to tracked fieldsv3
  24. Lead sponsor: Boston Children's Hospital to Wanda Phipatanakulv2
  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.
This trial is a randomized, double-blind, placebo controlled trial designed to test whether two years treatment of preschool children aged 2-3 years of age at high risk for asthma with omalizumab (anti-IgE) for two years will prevent the progression to childhood asthma, as reflected by a reduction in the prevalence of active asthma in the Final 12 months during 2 year observation period off study drug.
Trial Details
NCT Number NCT02570984
Lead Sponsor Boston Children's Hospital
Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
Conditions
(from sponsor)		 Asthma
Related terms Asthma
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov