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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 is a Phase 3 study that has completed, run by AstraZeneca. The registered enrollment target is 297 participants.
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
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06075095
The ClinicalTrials.gov registry entry for NCT06075095 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 297 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AstraZeneca, which has 1,285 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo MDI HFA is the first listed.
NCT06075095 reports 0 study locations.
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.
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