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

PHASE3RECRUITING

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.

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Study details:

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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

Male or female participants must be 40 to 80 years of age inclusive, at the time of signing the ICF.

Demonstrate acceptable MDI administration technique at Visit 1 (V1) and Visit 2 (V2)

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

A CAT score of ≥ 10 at Visit 1.

Participant must fulfill at least 1 of the 4 CV disease/risk factor criteria below [(a), (b), (c), or (d)]: (1) Established CV Disease (2) Combination of CV risk factors: Hypertension, Diabetes Mellitus, Chronic Kidney Disease, Dyslipidemia, Obesity (3) High risk of CV disease determined using an established CV risk assessment tool. (4) CT coronary Artery Calcification

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: 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 highly effective form of birth control.

Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in the protocol.

Exclusion criteria

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.

End-stage renal disease requiring renal replacement therapy

History of heart or lung transplant or actively listed for heart or lung transplant.

Implanted left ventricular assist device or implant anticipated in < 3 months.

History of lung cancer and/or treatment for lung cancer within the 5 years prior to Visit 1.

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.

Pneumonia and/or moderate or severe COPD exacerbation that has not resolved at least 8 weeks prior to Visit 1

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.

Use of maintenance ICS treatment within the past 12 months.

Unable to abstain from protocol-defined prohibited medications

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).

Participants with a known hypersensitivity to LAMA, LABA or ICS or any component of the MDI.

Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).

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.

Previous randomization in the present study.

For females only - currently pregnant (confirmed with positive pregnancy test) or breastfeeding

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Eligibility

Age eligible for study : 40 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2024-02-21

Primary completion: 2028-03-03

Study completion finish: 2028-03-03

Study type

TREATMENT

Phase

PHASE3

Trial ID

NCT06283966

Intervention or treatment

DRUG: BGF MDI 320/14.4/9.6 μg

DRUG: GFF MDI 14.4/9.6 μg

Conditions

• COPD (Chronic Obstructive Pulmonary Disease)

Image related to COPD (Chronic Obstructive Pulmonary Disease)

Condition: COPD (Chronic Obstructive Pulmonary Disease)
DRUG: BGF MDI 320/14.4/9.6 μg and other drugs
Chermside, Not Specified, Australia and more
Sponsor: AstraZeneca

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Find a site

Closest Location:

Research Site

Research sites nearby

Select from list below to view details:

Research Site
Chermside, Not Specified, Australia
Research Site
St Albans, Not Specified, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: BGF arm BGF MDI 320/14.4/9.6 μg BID	DRUG: BGF MDI 320/14.4/9.6 μg Budesonide, glycopyrronium, and formoterol fumarate pressurized inhalation suspension
EXPERIMENTAL: GFF arm GFF MDI 14.4/9.6 μg BID	DRUG: GFF MDI 14.4/9.6 μg Glycopyrronium and formoterol fumarate pressurized inhalation suspension

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
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.	Up to 3 years

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
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.	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.	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.	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.	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).	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).	Up to 3 years

Frequently Asked Questions

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References

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