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NCT06075095 · ClinicalTrials.gov registry record · Phase 3
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
A Phase 3 study, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 3
- Development phase
- 297
- Enrollment target
NCT06075095: Completed Phase 3 study, sponsored by AstraZeneca.
NCT06075095 is a Phase 3 study that has completed, run by AstraZeneca. The registered enrollment target is 297 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06075095, a Phase 3 study, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 297 participants
- Enrollment target
Study Summary
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
Primary Outcome
To assess the equivalence of BGF MDI HFO relative to BGF MDI HFA on lung function in participants with COPD
Interventions
- DRUG Placebo MDI HFA
- DRUG BGF MDI HFA 320/14.4/9.6 μg
- DRUG BGF MDI HFO 320/14.4/9.6μg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 297 participants |
| Start Date | 2024-01-11 |
| Est. Completion | 2025-08-12 |
| Phase | Phase 3 |
What the finished NCT06075095 record still lists
NCT06075095 is an interventional study that assigns participants to a tested intervention. The registered 297 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (62% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo MDI HFA is the first listed.
NCT06075095 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06075095 about?
NCT06075095 is a clinical study titled "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". 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 app...
What is the current status of trial NCT06075095?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 297 participants. The study started on 2024-01-11. Estimated completion is 2025-08-12.
What interventions are being tested in trial NCT06075095?
The interventions under investigation include: Placebo MDI HFA (DRUG), BGF MDI HFA 320/14.4/9.6 μg (DRUG), BGF MDI HFO 320/14.4/9.6μg (DRUG).
Who is sponsoring clinical trial NCT06075095?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06075095's enrollment target sits among peer trials
297 1163rd of 2000 higher than 837 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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