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Study of Budesonide, Glycopyrronium, and Formoterol Fumarate for COPD

This study is looking at how well a combination inhaler called BGF MDI (Budesonide, glycopyrronium, and formoterol fumarate) works for people with Chronic Obstructive Pulmonary Disease (COPD) who are also at risk for heart or lung problems. It compares BGF MDI to another inhaler, GFF MDI (Glycopyrronium and formoterol fumarate). We want to see if BGF MDI can reduce the time until someone experiences a severe heart or COPD event. You may be able to join if you are between 40 and 80 years old, have a confirmed COPD diagnosis, and can use an inhaler correctly. The study aims to enroll 5250 participants, but its current recruitment status is unclear.

Study design
This is a Phase III study that randomly assigns participants to one of two treatment groups. It is double-blind, meaning neither you nor your doctor will know which treatment you are receiving.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 3 years to track severe cardiac or COPD events.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06283966

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

Recruiting
PHASE3Ages 40–80InterventionalTreatment
AstraZeneca
~5,000 participants
Updated 2026-08-26 on ClinicalTrials.gov
What's tested:BGF MDI 320/14.4/9.6 μgGFF MDI 14.4/9.6 μg

At a glance

Recruiting sites
685 of 921 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Time to first severe cardiac or COPD event
Measured over Up to 3 years

Conditions

COPD (Chronic Obstructive Pulmonary Disease)

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Where it's being run

921 sites across 81 states
China98
Germany52
Florida42
Poland40
Brazil39
Texas34
Bulgaria33
France30

Who to contact

AstraZeneca Clinical Study Information Center
[email protected]
1-877-240-9479
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Hypertension
Diabetes Mellitus
Chronic Kidney Disease
Dyslipidemia
Obesity 3. : High risk of CV disease determined using an established CV risk assessment
Non-childbearing potential: either permanently sterilized or who are post-menopausal.
Childbearing potential: has a negative serum pregnancy test at V1 and must use one

What this trial measures

  • Time to first severe cardiac or COPD eventUp to 3 years

    Evaluate the effect of combination triple therapy (BGF MDI 320/14.4/9.6 μg) compared with dual bronchodilator therapy (GFF MDI 14.4/9.6 μg) on cardiopulmonary outcomes.