A Study to Investigate the Effect on Lung Function of an Approved COPD Treatment (BGF, With HFA Propellant) Compared to BGF Formulated With a Next-Generation Propellant in Participants 40 to 80 Years of Age With COPD
Public ClinicalTrials.gov record NCT06075095. 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 Randomised, Placebo-Controlled, Double-Blind, Multi-Centre, 4-week, 3-way Crossover Pharmacodynamic Study to Assess the Equivalence of Budesonide, Glycopyrronium, and Formoterol Fumarate (BGF) Delivered by MDI HFO Compared With BGF Delivered by MDI HFA in Participants With Chronic Obstructive Pulmonary Disease
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to demonstrate that the lung function effect from orally inhaled BGF delivered via HFO propellant is equivalent to the lung function effect from orally inhaled BGF delivered via HFA propellant in participants with COPD. The study duration for each participant will be approximately 15 to 16 weeks and consist of: 1. A screening and placebo run-in period of approximately 2 weeks prior to first dosing 2. Three treatment periods of approximately 4 weeks each (one period for each of 3 study interventions) 3. A final safety follow-up visit via telephone contact approximately 1 to 2 weeks after the final dose administration Participants will be provided with rescue SABA (albuterol or salbutamol) to be used as needed throughout the study. Participants will attend in-clinic study visits approximately weekly during the screening/run-in period (Visits 1, 2, and 3), then every 4 weeks (Visits 4, 5, and 6) to receive take-home study treatment, measure their lung function, and assess their health and safety
Study identification
- NCT ID
- NCT06075095
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 297 participants
Conditions and interventions
Conditions
Interventions
- BGF MDI HFO 320/14.4/9.6μg Drug
- BGF MDI HFA 320/14.4/9.6 μg Drug
- Placebo MDI HFA Drug
Drug
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
- Jan 10, 2024
- Primary completion
- Aug 11, 2025
- Completion
- Aug 11, 2025
- Last update posted
- Aug 26, 2025
2024 – 2025
United States locations
- U.S. sites
- 19
- U.S. states
- 12
- U.S. cities
- 19
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Research Site | Sheffield | Alabama | 35660 | — |
| Research Site | Clearwater | Florida | 33765 | — |
| Research Site | Gainesville | Florida | 32605 | — |
| Research Site | Miami | Florida | 33175 | — |
| Research Site | Orlando | Florida | 32825 | — |
| Research Site | Tampa | Florida | 33606 | — |
| Research Site | Rincon | Georgia | 31326 | — |
| Research Site | Chicago | Illinois | 60607 | — |
| Research Site | Saint Charles | Missouri | 63301 | — |
| Research Site | St Louis | Missouri | 63141 | — |
| Research Site | The Bronx | New York | 10455 | — |
| Research Site | Raleigh | North Carolina | 27607 | — |
| Research Site | Dublin | Ohio | 43016 | — |
| Research Site | Medford | Oregon | 97504 | — |
| Research Site | Portland | Oregon | 97202 | — |
| Research Site | Philadelphia | Pennsylvania | 19114 | — |
| Research Site | Gaffney | South Carolina | 29340 | — |
| Research Site | Boerne | Texas | 78006 | — |
| Research Site | El Paso | Texas | 79912 | — |
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 68 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06075095, 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 Aug 26, 2025 · Synced Sep 8, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06075095 live on ClinicalTrials.gov.