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A Study to Investigate the Effect of Budesonide/Glycopyrronium/Formoterol Fumarate Metered Dose Inhaler (BGF MDI) Compared With Placebo MDI on Heart and Lung Function in Participants With Chronic Obstructive Pulmonary Disease (COPD) and Hyperinflation

Study acronym: ORATOS
StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Interventions: Budesonide/Glycopyrronium/Formoterol Fumarate (Drug), Metered dose inhaler (Device), Placebo (Drug) to Budesonide/Glycopyrronium/Formoterol Fumarate (Drug), Metered dose inhaler (Device), Placebo (Drug) Eligibility criteria shortened, about 13 words · Secondary endpoints: details revised at 2 of 2 entries · Study description expanded, about 4 words Show 3 more changesShow less
    • Eligibility criteria shortened, about 13 words
    • Secondary endpoints: details revised at 2 of 2 entries
    • Study description expanded, about 4 words
  2. 2 versions Re-verified since Jul 23, 2026, no change to tracked fieldsv10-v11
  3. Site details revised at 1 of 7 sitesv9
  4. Site details revised at 1 of 7 sitesv8
  5. Site details revised at 2 of 7 sitesv7
Show 5 earlier versionsHide 5 earlier versions
  1. Study sites: 6 to 7v6
  2. Re-verified, no change to tracked fieldsv5
  3. Primary endpoint revised Primary and study completion dates: Mar 31, 2027 to May 31, 2027 · Study description expanded, about 11 words · Site details revised at 2 of 6 sites · 2 morev4 Show 5 more changesShow less
    • Primary and study completion dates: Mar 31, 2027 to May 31, 2027
    • Study description expanded, about 11 words
    • Site details revised at 2 of 6 sites
    • Eligibility criteria expanded, about 2 words
    • Study title expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  4. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 6 · Start date changed from estimate of Nov 14, 2025 to Nov 24, 2025v3 Show 2 more changesShow less
    • Study sites: 0 to 6
    • Start date changed from estimate of Nov 14, 2025 to Nov 24, 2025
  5. Start date: Sep 30, 2025 to Nov 14, 2025v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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
The purpose of the study is to evaluate the effect of BGF MDI compared with placebo MDI on cardiac and lung function when administered in participants diagnosed with COPD and hyperinflation.
Trial Details
NCT Number NCT07073950
Lead Sponsor AstraZeneca
Collaborators: Parexel
Conditions Chronic Obstructive Pulmonary Disease, Hyperinflation
Enrollment 56 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov