A Study to Investigate the Effect on Lung Function of an Approved COPD Treatment (BGF, With HFA Propellant) Compared to BGF Formulated With a New Propellant (HFO) in Participants 40 to 80 Years of Age With COPD

• Status: Recruiting
• Trial end date: 2025-09-05

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

• Phase: Phase 3

Details

• Lead Sponsor: AstraZeneca
• Treatments: Budesonide; Formoterol Fumarate; Glycopyrrolate