A Study to Assess the Safety of Budesonide/Glycopyrronium/Formoterol Fumarate With a Next-Generation Propellant in Participants With Moderate to Very Severe Chronic Obstructive Pulmonary Disease
Public ClinicalTrials.gov record NCT05573464. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Double-Blind, 12-Week (With an Extension to 52 Weeks in a Subset of Participants), Multi-Center Study to Assess the Safety of Budesonide, Glycopyrronium, and Formoterol Fumarate (BGF) Delivered by MDI HFO Compared to BGF Delivered by MDI HFA in Participants With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a 12-week (with an extension to 52 weeks in a subset of participants) study comparing the safety of BGF MDI HFO twice daily (BID) with BGF MDI HFA BID in participants with moderate to very severe COPD.
Study identification
- NCT ID
- NCT05573464
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 559 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 40 Years to 80 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 27, 2022 (Actual)
- Primary completion
- Mar 26, 2024 (Actual)
- Completion
- Mar 26, 2024 (Actual)
- Last update posted
- Sep 19, 2025
2022 – 2024
United States locations
- U.S. sites
- 20
- U.S. states
- 13
- U.S. cities
- 20
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Research Site | Phoenix | Arizona | 85032 | — |
| Research Site | Newport Beach | California | 92663 | — |
| Research Site | Miami | Florida | 33175 | — |
| Research Site | Sarasota | Florida | 34239 | — |
| Research Site | Tampa | Florida | 33606 | — |
| Research Site | Valparaiso | Indiana | 46383 | — |
| Research Site | Crowley | Louisiana | 70526 | — |
| Research Site | North Dartmouth | Massachusetts | 02747 | — |
| Research Site | St Louis | Missouri | 63141 | — |
| Research Site | Charlotte | North Carolina | 28209 | — |
| Research Site | Wilmington | North Carolina | 28401 | — |
| Research Site | Dublin | Ohio | 43016 | — |
| Research Site | Grants Pass | Oregon | 97527 | — |
| Research Site | Portland | Oregon | 97202 | — |
| Research Site | Anderson | South Carolina | 29621 | — |
| Research Site | Columbia | South Carolina | 29204 | — |
| Research Site | Gaffney | South Carolina | 29340 | — |
| Research Site | Longview | Texas | 75605 | — |
| Research Site | McKinney | Texas | 75069 | — |
| Research Site | Richmond | Virginia | 23219 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 71 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05573464, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 19, 2025 · Synced Oct 25, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05573464 live on ClinicalTrials.gov.