Phase 3 N=559 Randomized Quadruple-blind Treatment

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

Chronic Obstructive Pulmonary Disease (COPD)

Bottom Line

View on ClinicalTrials.gov: NCT05573464 ↗

Enrolled (actual)

559

Serious AEs

8.8%

Results posted

Sep 2025

Primary outcome: Primary: Number and Percentage of Participants With Serious Adverse Events — 15; 12; 265; 266 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: BGF MDI HFO 320/14.4/9.6 μg (Drug); BGF MDI HFA 320/14.4/9.6 μg (Drug)
Age: Adult, Older Adult · 40+ yrs
Sex: All
Sponsor: AstraZeneca
Primary completion: Mar 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Number and Percentage of Participants With Serious Adverse Events	17; 16; 103; 104	—
PRIMARY Number and Percentage of Participants With Serious Adverse Events	17; 16; 103; 104	—
PRIMARY Number and Percentage of Participants With Non-serious Adverse Events >5%	46; 67; 74; 53	—
PRIMARY Number and Percentage of Participants With Non-serious Adverse Events >5%	46; 67; 74; 53	—
PRIMARY Number and Percentage of Participants With Adverse Events of Special Interest	40; 47; 80; 73	—
PRIMARY Number and Percentage of Participants With Adverse Events of Special Interest	40; 47; 80; 73	—

Summary

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.

Eligibility Criteria

Inclusion Criteria

Participant must be 40 to 80 years of age inclusive, at the time of signing the ICF;
Participants who have a documented history of physician-diagnosed COPD as defined by the ATS/ERS (Celli et al 2004) or by locally applicable guidelines;
Participants who have been regularly using dual ICS/LABA, LAMA/LABA, or ICS/LAMA/LABA (open or fixed-dose combinations) inhaled maintenance therapies for the management of their COPD for at least 6 weeks prior to Screening;
Participants who have pre-bronchodilator FEV1 of 480 msec will be excluded. Participants with high degree atrioventricular block II or III, or with sinus node dysfunction with clinically significant pauses who are not treated with pacemaker will also be excluded.
Planned hospitalization during the study;
Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site);
Study Investigators, sub-Investigators, coordinators, and their employee or immediate family members;
Judgment by the Investigator that the participant is unlikely to comply with study procedures, restrictions and requirements;
For women only - currently pregnant (confirmed with positive pregnancy test), breast feeding, or planned pregnancy during the study or women of childbearing potential not using acceptable contraception measures (see Inclusion criterion 12 in Section 5.1).

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05573464). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.