Recruiting

Phase 3

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

Sponsor:

AstraZeneca

Code:

NCT06283966

Conditions

COPD (Chronic Obstructive Pulmonary Disease)

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Interventions

BGF MDI 320/14.4/9.6 μg

GFF MDI 14.4/9.6 μg

Study Details

Brief summary:

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.

Conditions

COPD (Chronic Obstructive Pulmonary Disease)

Study ID

NCT06283966

Start date

Feb 21, 2024

Status verified date

Aug, 2026

Completion date

Dec 3, 2027

Anticipated

Primary completion date

Dec 3, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

the ICF.
2. Demonstrate acceptable MDI administration technique at Visit 1 (V1) and Visit 2 (V2)
3. A diagnosis of COPD confirmed by a post-bronchodilator FEV1/FVC ratio < 70%

at V1.
4. 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.
5. A baseline peripheral blood eosinophil count of ≥ 100 cells/mm3 assessed at Visit 1 by

the central laboratory
6. A CAT score of ≥ 10 at Visit 1.
7. 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
8. Willing and, in the opinion of the investigator, able to adjust current COPD therapy, as

required by the protocol.
9. Willing to visit at the study site or participate in virtual visits as required per the protocol

to complete all study assessments.
10. 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.
11. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in the protocol.

Exclusion Criteria:

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

Study Design

Enrollment

5000 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: BGF arm

BGF MDI 320/14.4/9.6 μg BID

experimental: GFF arm

GFF MDI 14.4/9.6 μg BID

Interventions

BGF MDI 320/14.4/9.6 μg

Budesonide, glycopyrronium, and formoterol fumarate pressurized inhalation suspension

GFF MDI 14.4/9.6 μg

Glycopyrronium and formoterol fumarate pressurized inhalation suspension

Primary outcome measure

Time to first severe cardiac or COPD event [ Time Frame: Up to 3 years ]

Central Contacts and Locations

Central contacts

AstraZeneca Clinical Study Information Center

1-877-240-9479 information.center@astrazeneca.com

Locations

Research Site

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Cullman, Alabama, United States, 35058

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Mobile, Alabama, United States, 36608

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Gilbert, Arizona, United States, 85296

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Mesa, Arizona, United States, 85206

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Mesa, Arizona, United States, 85213

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Tucson, Arizona, United States, 85710

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Tucson, Arizona, United States, 85715

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Castroville, California, United States, 95012

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Garden Grove, California, United States, 92844

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Inglewood, California, United States, 90301

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La Mesa, California, United States, 91942

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La Palma, California, United States, 90623

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Lomita, California, United States, 90717

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Long Beach, California, United States, 90815

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Mission Viejo, California, United States, 92691

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Newport Beach, California, United States, 92663

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Pomona, California, United States, 91768

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Sacramento, California, United States, 95823

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Sacramento, California, United States, 95831

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Tarzana, California, United States, 91356

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Thousand Oaks, California, United States, 91360

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Vista, California, United States, 92081

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Aurora, Colorado, United States, 80012

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Denver, Colorado, United States, 80228

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Boynton Beach, Florida, United States, 33435

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Bradenton, Florida, United States, 34209

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Cape Coral, Florida, United States, 33990

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Clearwater, Florida, United States, 33756

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Clearwater, Florida, United States, 33765

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Crystal River, Florida, United States, 34429

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Edgewater, Florida, United States, 32132

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Fort Lauderdale, Florida, United States, 33308

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Hollywood, Florida, United States, 33024

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Homestead, Florida, United States, 33033

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Kissimmee, Florida, United States, 34746

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Lake City, Florida, United States, 32055

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Lake Worth, Florida, United States, 33467

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Lakeland, Florida, United States, 33805

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Lakeland, Florida, United States, 33813

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Miami, Florida, United States, 33155

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Miami, Florida, United States, 33175

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Miami Lakes, Florida, United States, 33016

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Naples, Florida, United States, 34102

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Ocala, Florida, United States, 34470

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Orlando, Florida, United States, 32807

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Orlando, Florida, United States, 32819

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Orlando, Florida, United States, 32825

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Ormond Beach, Florida, United States, 32174

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Plantation, Florida, United States, 33324

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St. Petersburg, Florida, United States, 33713

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Tamarac, Florida, United States, 33321

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Tampa, Florida, United States, 33606

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Savannah, Georgia, United States, 31406

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Tucker, Georgia, United States, 30084

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Chicago, Illinois, United States, 60607

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Winfield, Illinois, United States, 60190

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Valparaiso, Indiana, United States, 46383

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Sioux City, Iowa, United States, 51106

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Wichita, Kansas, United States, 67218

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Lexington, Kentucky, United States, 40503

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Lafayette, Louisiana, United States, 70508

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Monroe, Louisiana, United States, 71201

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Zachary, Louisiana, United States, 70791

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Oxon Hill, Maryland, United States, 20745

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Boston, Massachusetts, United States, 02115

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Ann Arbor, Michigan, United States, 48109

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Flint, Michigan, United States, 48504

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Southfield, Michigan, United States, 48034

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Southfield, Michigan, United States, 48075

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Gulfport, Mississippi, United States, 39503

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Olive Branch, Mississippi, United States, 38654

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St Louis, Missouri, United States, 63104

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Missoula, Montana, United States, 59808

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Fremont, Nebraska, United States, 68025

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Grand Island, Nebraska, United States, 68803

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Las Vegas, Nevada, United States, 89101

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Las Vegas, Nevada, United States, 89121

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Mullica Hill, New Jersey, United States, 08062

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Toms River, New Jersey, United States, 08755

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Albany, New York, United States, 12205

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Massapequa, New York, United States, 11758

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New Windsor, New York, United States, 12553

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New York, New York, United States, 10036

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New York, New York, United States, 10065

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The Bronx, New York, United States, 10455

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Greensboro, North Carolina, United States, 27405

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Greenville, North Carolina, United States, 27834

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Huntersville, North Carolina, United States, 28078

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Morehead City, North Carolina, United States, 28557

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Statesville, North Carolina, United States, 28625

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Winston-Salem, North Carolina, United States, 27104

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Blue Ash, Ohio, United States, 45242

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Columbus, Ohio, United States, 43215

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Marion, Ohio, United States, 43302

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Norman, Oklahoma, United States, 73071

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Oklahoma City, Oklahoma, United States, 73134

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Tulsa, Oklahoma, United States, 74133

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Medford, Oregon, United States, 97504

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Camp Hill, Pennsylvania, United States, 17011

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Philadelphia, Pennsylvania, United States, 19107

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Philadelphia, Pennsylvania, United States, 19140

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Anderson, South Carolina, United States, 29621

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Charleston, South Carolina, United States, 29414

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Gaffney, South Carolina, United States, 29340

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Spartanburg, South Carolina, United States, 29303

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Union, South Carolina, United States, 29379

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Rapid City, South Dakota, United States, 57701

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Sioux Falls, South Dakota, United States, 57104

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Chattanooga, Tennessee, United States, 37421

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Franklin, Tennessee, United States, 37067

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Tullahoma, Tennessee, United States, 37388

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Abilene, Texas, United States, 79606

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Brownsville, Texas, United States, 78520

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Dallas, Texas, United States, 75254

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El Paso, Texas, United States, 79902

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Forney, Texas, United States, 75126

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Houston, Texas, United States, 77002

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Houston, Texas, United States, 77079

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Houston, Texas, United States, 77089

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Kingwood, Texas, United States, 77339

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McAllen, Texas, United States, 78504

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McKinney, Texas, United States, 75069

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Paris, Texas, United States, 75462

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Plano, Texas, United States, 75093

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Waco, Texas, United States, 76708

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Wylie, Texas, United States, 75098

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Ogden, Utah, United States, 84405

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West Valley City, Utah, United States, 84120

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Norfolk, Virginia, United States, 23504

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Richmond, Virginia, United States, 23219

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Suffolk, Virginia, United States, 23435

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Spokane, Washington, United States, 99218

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Cudahy, Wisconsin, United States, 53110

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Milwaukee, Wisconsin, United States, 53228

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Calgary, Alberta, Canada, T3R 1W7

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Sherwood Park, Alberta, Canada, T8L 0N2

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Kelowna, British Columbia, Canada, V1Y 1Z9

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Richmond, British Columbia, Canada, V6V 2L1

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Winnipeg, Manitoba, Canada, R3L 1Z5

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Sydney, Nova Scotia, Canada, B1M 0A1

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Ajax, Ontario, Canada, L1S 2J5

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Guelph, Ontario, Canada, N1H 1B1

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Hamilton, Ontario, Canada, L8L 5G4

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Kingston, Ontario, Canada, K7L 2V7

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Kingston, Ontario, Canada, K7M 4E7

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Thunder Bay, Ontario, Canada, P7B 7C7

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Montreal, Quebec, Canada, H4A 3J1

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Québec, Quebec, Canada, G1G 5X1

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Québec, Quebec, Canada, G1V 4G5

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Québec, Quebec, Canada, G1W 4R4

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Saint-Charles-Borromée, Quebec, Canada, J6E 2B4

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Trois-Rivières, Quebec, Canada, G8T 7A1

Research Site

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Trois-Rivières, Quebec, Canada, G9A 4P3

More Information

Sponsor

AstraZeneca

Last update posted

Aug 26, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by AstraZeneca on 2026-08-26.