A Phase 3 interventional study of BGF MDI 320/14.4/9.6 μg and GFF MDI 14.4/9.6 μg in COPD (Chronic Obstructive Pulmonary Disease), sponsored by AstraZeneca. Recruiting at 921 sites in 37 countries. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-08-26.
Sponsored by AstraZeneca · Phase 3, Interventional, and Treatment
This study will evaluate the effect of triple ICS/LAMA/LABA therapy with BGF MDI 320/14.4/9.6 μg on cardiopulmonary outcomes relative to LAMA/LABA therapy with GFF MDI 14.4/9.6 μg in a population with COPD and elevated cardiopulmonary risk.
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.
Male or female participants must be 40 to 80 years of age inclusive, at the time of signing
the ICF.
A diagnosis of COPD confirmed by a post-bronchodilator FEV1/FVC ratio \< 70%
at V1.
Current or former smokers with a history of at least 10 pack-years of cigarette smoking;
defined as (number of cigarettes per day/20) x number of years smoked. Previous smokers are defined as those who have stopped smoking for at least 6
months prior to V1.
A baseline peripheral blood eosinophil count of ≥ 100 cells/mm3 assessed at Visit 1 by
the central laboratory
Participant must fulfill at least 1 of the 4 CV disease/risk factor criteria below [(a), (b),
(c), or (d)]:
: Combination of CV risk factors:
: High risk of CV disease determined using an established CV risk assessment
tool.
Willing and, in the opinion of the investigator, able to adjust current COPD therapy, as
required by the protocol.
Willing to visit at the study site or participate in virtual visits as required per the protocol
to complete all study assessments.
A female is eligible to enter and participate in the study if the female is of:
highly effective form of birth control.
Exclusion Criteria:
Unstable or life-threatening cardiac disease - participants with any of the following at Visit 1 would be excluded:
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.
BGF MDI 320/14.4/9.6 μg BID
Drug: BGF MDI 320/14.4/9.6 μg
GFF MDI 14.4/9.6 μg BID
Drug: GFF MDI 14.4/9.6 μg
Budesonide, glycopyrronium, and formoterol fumarate pressurized inhalation suspension
Glycopyrronium and formoterol fumarate pressurized inhalation suspension
Time to first severe cardiac or COPD event
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.
Time frame: Up to 3 years
Time to first severe COPD exacerbation event
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 severe COPD exacerbations.
Time frame: Up to 3 years
Time to first severe cardiac event
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 severe cardiac outcomes.
Time frame: Up to 3 years
Time to cardiopulmonary death
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 deaths.
Time frame: Up to 3 years
Moderate/severe COPD exacerbation rate
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 moderate/severe COPD exacerbations.
Time frame: Over time, up 3 years
Time to Myocardial Infarction (MI) hospitalization or cardiac death
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 the time to MI hospitalization (or cardiac death).
Time frame: Up to 3 years
Time to Heart Failure (HF) acute healthcare visit/hospitalization or cardiac death
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 the time to HF acute healthcare visit/hospitalization (or cardiac death).
Time frame: Up to 3 years
Serious Adverse Events (SAEs) and Adverse Events leading to discontinuation (DAEs), Adverse Events of Special Interest (AESIs) of pneumonia leading to hospitalization or death
To assess the safety and tolerability of BGF MDI and GFF MDI
Time frame: Up to 3 years
Showing the first 100 of 921 sites across 37 countries.
Plan to share: Yes — Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Supporting information: Study protocol, Sap
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