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Evaluating the Efficacy and Safety of PT027 Compared With PT007 Administered As Needed in Participants 12 to < 18 Years of Age With Asthma

Study acronym: ACADIA
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial sites expanded: 150 → 154 locations Eligibility criteria expanded, about 26 words · Secondary endpoints: details revised at 2 of 12 entries · Publications: details revised at 1 of 1 entry · 1 more Show 4 more changesShow less
    • Eligibility criteria expanded, about 26 words
    • Secondary endpoints: details revised at 2 of 12 entries
    • Publications: details revised at 1 of 1 entry
    • Study description expanded, about 3 words
  2. Trial sites expanded: 144 → 150 locationsv23
  3. Trial sites expanded: 140 → 144 locationsv22
  4. Trial sites expanded: 135 → 140 locationsv21
  5. Trial sites expanded: 131 → 135 locationsv20
Show 18 earlier versionsHide 18 earlier versions
  1. Site details revised at 4 of 131 sitesv19
  2. Study sites: 129 to 131v18
  3. Re-verified, no change to tracked fieldsv17
  4. Study sites: 128 to 129v16
  5. Study sites: 124 to 128v15
  6. Study sites: 123 to 124v14
  7. Study sites: 121 to 123v13
  8. Site details revised at 8 of 121 sitesv12
  9. Study sites: 109 to 121v11
  10. Site details revised at 1 of 109 sitesv10
  11. Study sites: 98 to 109v9
  12. Study sites: 94 to 98 Eligibility criteria revisedv8 Show 1 more changeShow less
    • Eligibility criteria revised

    See this version in full on ClinicalTrials.gov ↗

  13. Study sites: 92 to 94v7
  14. Study sites: 63 to 92v6
  15. Study sites: 32 to 63v5
  16. Study sites: 25 to 32 Primary and study completion dates: Oct 6, 2027 to Oct 13, 2027v4 Show 1 more changeShow less
    • Primary and study completion dates: Oct 6, 2027 to Oct 13, 2027
  17. Trial status: Not Yet Recruiting to Recruiting Study sites: 1 to 25 · Primary and study completion dates: Oct 13, 2027 to Oct 6, 2027 · Start date changed from estimate of May 8, 2024 to May 20, 2024 · 1 morev3 Show 4 more changesShow less
    • Study sites: 1 to 25
    • Primary and study completion dates: Oct 13, 2027 to Oct 6, 2027
    • Start date changed from estimate of May 8, 2024 to May 20, 2024
    • Secondary endpoints revised (12)

    See this version in full on ClinicalTrials.gov ↗

  18. Start date: Mar 27, 2024 to May 8, 2024 Study sites: 0 to 1v2 Show 1 more changeShow less
    • Study sites: 0 to 1
  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.
AstraZeneca
727 trials monitored
See 61 trials at risk
Asthma
927 trials monitored
See 32 trials at risk
The purpose of this study is to compare the effect of budesonide/albuterol metered-dose inhaler (BDA MDI) with albuterol sulfate metered-dose inhaler (AS MDI), both administered as needed, on the annualized rate of severe asthma exacerbations in adolescents with a documented clinical diagnosis of asthma and at least one severe exacerbation in the prior year.
Trial Details
NCT Number NCT06307665
Lead Sponsor AstraZeneca
Collaborators: Parexel
Conditions Asthma
Enrollment 440 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov