Home
Clinical Trials
A Study Evaluating the Effica...

A Study Evaluating the Efficacy of Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dosed Inhaler on Cardiopulmonary Outcomes in Chronic Obstructive Pulmonary Disease

Last Updated: 2026-01-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

5000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-21

Study Completion Date

2028-03-07

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This is a Phase III randomized, double-blind, parallel group, multi-center event-driven study comparing BGF MDI 320/14.4/9.6 μg BID with GFF MDI 14.4/9.6 μg BID in participants with COPD who are at risk of a cardiopulmonary event.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

COPD (Chronic Obstructive Pulmonary Disease)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

BGF arm

BGF MDI 320/14.4/9.6 μg BID

Group Type EXPERIMENTAL

BGF MDI 320/14.4/9.6 μg

Intervention Type DRUG

Budesonide, glycopyrronium, and formoterol fumarate pressurized inhalation suspension

GFF arm

GFF MDI 14.4/9.6 μg BID

Group Type EXPERIMENTAL

GFF MDI 14.4/9.6 μg

1. Active diagnosis of asthma within the past 5 years (previous diagnosis as a child or adolescent are eligible), asthma-COPD overlap, or any other chronic respiratory disease other than COPD such as alpha-1 antitrypsin deficiency, active tuberculosis, lung fibrosis, sarcoidosis, interstitial lung disease, and pulmonary hypertension.
2. End-stage renal disease requiring renal replacement therapy
3. History of heart or lung transplant or actively listed for heart or lung transplant.
4. Implanted left ventricular assist device or implant anticipated in \< 3 months.
5. History of lung cancer and/or treatment for lung cancer within the 5 years prior to Visit 1.
6. Unstable or life-threatening cardiac disease - participants with any of the following at Visit 1 would be excluded:

1. An MI or unstable angina in the last 8 weeks
2. Unstable or life-threatening cardiac arrhythmia requiring intervention in the last 8 weeks.

NOTE: Any participant who experiences unstable or life-threatening cardiac disease during the run-in period will be excluded but can be rescreened 8 weeks after the resolution of the event.
7. Pneumonia and/or moderate or severe COPD exacerbation that has not resolved at least 8 weeks prior to Visit 1
8. Any life-threatening condition, including malignancy, with a life expectancy \< 5 years, other than CV disease or COPD, that might prevent the participant from completing the study.
9. Use of maintenance ICS treatment within the past 12 months.
10. Unable to abstain from protocol-defined prohibited medications
11. Participation in another clinical study with a study intervention administered in the last 30 days or 5 half-lives, whichever is longer prior to Visit 1 (any other investigational product that is not identified in protocol is prohibited for use during the duration of the study).
12. Participants with a known hypersensitivity to LAMA, LABA or ICS or any component of the MDI.
13. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
14. Judgment by the investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions, and requirements.
15. Previous randomization in the present study.
16. For females only - currently pregnant (confirmed with positive pregnancy test) or breastfeeding

Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers