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A Study Evaluating the Efficacy of Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dosed Inhaler on Cardiopulmonary Outcomes in Chronic Obstructive Pulmonary Disease

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

Record History

  1. Enrollment target: 5000 to 5250 Study sites: 921 to 922 · Interventions: BGF MDI 320/14.4/9.6 μg (Drug), GFF MDI 14.4/9.6 μg (Drug) to BGF MDI 320/14.4/9.6 μg (Drug), GFF MDI 14.4/9.6 μg (Drug) · Eligibility criteria expanded, about 40 words · 1 more Show 4 more changesShow less
    • Study sites: 921 to 922
    • Interventions: BGF MDI 320/14.4/9.6 μg (Drug), GFF MDI 14.4/9.6 μg (Drug) to BGF MDI 320/14.4/9.6 μg (Drug), GFF MDI 14.4/9.6 μg (Drug)
    • Eligibility criteria expanded, about 40 words
    • Secondary endpoints: details revised at 6 of 6 entries
  2. Enrollment target: 5250 to 5000 Site details revised at 18 of 921 sitesv15 Show 1 more changeShow less
    • Site details revised at 18 of 921 sites
  3. Enrollment target: 5000 to 5250 Study sites: 920 to 921v14 Show 1 more changeShow less
    • Study sites: 920 to 921
  4. Trial sites expanded: 917 → 920 locations Primary and study completion moved earlier from Mar 7, 2028 to Dec 3, 2027v13 Show 1 more changeShow less
    • Primary and study completion moved earlier from Mar 7, 2028 to Dec 3, 2027
  5. Study sites: 918 to 917v12
Show 10 earlier versionsHide 10 earlier versions
  1. Study sites: 917 to 918v11
  2. Study sites: 911 to 917v10
  3. Site details revised at 394 of 911 sitesv9
  4. Study sites: 909 to 911 Primary and study completion dates: Feb 7, 2028 to Mar 7, 2028v8 Show 1 more changeShow less
    • Primary and study completion dates: Feb 7, 2028 to Mar 7, 2028
  5. Study sites: 892 to 909 Primary and study completion dates: Mar 7, 2028 to Feb 7, 2028v7 Show 1 more changeShow less
    • Primary and study completion dates: Mar 7, 2028 to Feb 7, 2028
  6. Study sites: 877 to 892v6
  7. Study sites: 863 to 877v5
  8. Study sites: 742 to 863 Primary and study completion dates: Mar 3, 2028 to Mar 7, 2028v4 Show 1 more changeShow less
    • Primary and study completion dates: Mar 3, 2028 to Mar 7, 2028
  9. Study sites: 683 to 742 Primary and study completion dates: Mar 6, 2028 to Mar 3, 2028v3 Show 1 more changeShow less
    • Primary and study completion dates: Mar 6, 2028 to Mar 3, 2028
  10. Trial status: Not Yet Recruiting to Recruiting Study sites: 591 to 683 · Primary and study completion dates: Mar 7, 2028 to Mar 6, 2028 · Start date changed from estimate of Feb 22, 2024 to Feb 21, 2024 · 1 morev2 Show 4 more changesShow less
    • Study sites: 591 to 683
    • Primary and study completion dates: Mar 7, 2028 to Mar 6, 2028
    • Start date changed from estimate of Feb 22, 2024 to Feb 21, 2024
    • Secondary endpoints: details revised at 1 of 6 entries
  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
COPD
1,068 trials monitored
See 31 trials at risk
This study will evaluate the effect of triple ICS/LAMA/LABA therapy with BGF MDI 320/14.4/9.6 μg on cardiopulmonary outcomes relative to LAMA/LABA therapy with GFF MDI 14.4/9.6 μg in a population with COPD and elevated cardiopulmonary risk.
Trial Details
NCT Number NCT06283966
Lead Sponsor AstraZeneca
Conditions COPD (Chronic Obstructive Pulmonary Disease)
Enrollment 5,250 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov