A Study Evaluating the Efficacy of Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dosed Inhaler on Cardiopulmonary Outcomes in Chronic Obstructive Pulmonary Disease
Purpose
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.
Condition
- COPD (Chronic Obstructive Pulmonary Disease)
Eligibility
- Eligible Ages
- Between 40 Years and 80 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
- 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
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- 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.
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental BGF arm |
BGF MDI 320/14.4/9.6 μg BID |
|
|
Experimental GFF arm |
GFF MDI 14.4/9.6 μg BID |
|
Recruiting Locations
Research Site
Athens, Alabama 35611
Athens, Alabama 35611
Research Site
Cullman, Alabama 35058
Cullman, Alabama 35058
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Fairhope, Alabama 36532
Fairhope, Alabama 36532
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Mobile, Alabama 36608
Mobile, Alabama 36608
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Gilbert, Arizona 85296
Gilbert, Arizona 85296
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Mesa, Arizona 85206
Mesa, Arizona 85206
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Mesa, Arizona 85213
Mesa, Arizona 85213
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Phoenix, Arizona 85040
Phoenix, Arizona 85040
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Tempe, Arizona 85281
Tempe, Arizona 85281
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Tucson, Arizona 85710
Tucson, Arizona 85710
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Canoga Park, California 91303
Canoga Park, California 91303
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Castroville, California 95012
Castroville, California 95012
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Garden Grove, California 92844
Garden Grove, California 92844
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Inglewood, California 90301
Inglewood, California 90301
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La Mesa, California 91942
La Mesa, California 91942
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La Palma, California 90623
La Palma, California 90623
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Lomita, California 90717
Lomita, California 90717
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Long Beach, California 90815
Long Beach, California 90815
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Newport Beach, California 92660
Newport Beach, California 92660
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Newport Beach, California 92663
Newport Beach, California 92663
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Pomona, California 91768
Pomona, California 91768
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Sacramento, California 95823
Sacramento, California 95823
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Sacramento, California 95831
Sacramento, California 95831
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San Diego, California 92111
San Diego, California 92111
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Tarzana, California 91356
Tarzana, California 91356
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Thousand Oaks, California 91360
Thousand Oaks, California 91360
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Vista, California 92081
Vista, California 92081
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Westminster, California 92683
Westminster, California 92683
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Aurora, Colorado 80012
Aurora, Colorado 80012
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Denver, Colorado 80228
Denver, Colorado 80228
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Englewood, Colorado 80110
Englewood, Colorado 80110
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Boynton Beach, Florida 33435
Boynton Beach, Florida 33435
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Bradenton, Florida 34209
Bradenton, Florida 34209
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Cape Coral, Florida 33990
Cape Coral, Florida 33990
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Clearwater, Florida 33756
Clearwater, Florida 33756
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Clearwater, Florida 33765
Clearwater, Florida 33765
Research Site
Crystal River, Florida 34429
Crystal River, Florida 34429
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Cutler Bay, Florida 33189
Cutler Bay, Florida 33189
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Edgewater, Florida 32132
Edgewater, Florida 32132
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Fort Lauderdale, Florida 33308
Fort Lauderdale, Florida 33308
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Fort Myers, Florida 33912
Fort Myers, Florida 33912
Research Site
Hialeah, Florida 33012
Hialeah, Florida 33012
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Hialeah, Florida 33013
Hialeah, Florida 33013
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Hollywood, Florida 33024
Hollywood, Florida 33024
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Homestead, Florida 33032
Homestead, Florida 33032
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Kissimmee, Florida 34746
Kissimmee, Florida 34746
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Lake City, Florida 32055
Lake City, Florida 32055
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Lake Worth, Florida 33467
Lake Worth, Florida 33467
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Lakeland, Florida 33805
Lakeland, Florida 33805
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Lakeland, Florida 33813
Lakeland, Florida 33813
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Miami Lakes, Florida 33014
Miami Lakes, Florida 33014
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Miami, Florida 33155
Miami, Florida 33155
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Miami, Florida 33175
Miami, Florida 33175
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Naples, Florida 34102
Naples, Florida 34102
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Ocala, Florida 34470
Ocala, Florida 34470
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Orlando, Florida 32807
Orlando, Florida 32807
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Orlando, Florida 32819
Orlando, Florida 32819
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Orlando, Florida 32825
Orlando, Florida 32825
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Ormond Beach, Florida 32174
Ormond Beach, Florida 32174
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Pembroke Pines, Florida 33024
Pembroke Pines, Florida 33024
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Plantation, Florida 33324
Plantation, Florida 33324
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Saint Petersburg, Florida 33713
Saint Petersburg, Florida 33713
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Sun City Center, Florida 33573
Sun City Center, Florida 33573
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Tamarac, Florida 33321
Tamarac, Florida 33321
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Tampa, Florida 33606
Tampa, Florida 33606
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Tampa, Florida 33607
Tampa, Florida 33607
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Tampa, Florida 33625
Tampa, Florida 33625
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Atlanta, Georgia 30349
Atlanta, Georgia 30349
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Savannah, Georgia 31406
Savannah, Georgia 31406
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Tucker, Georgia 30084
Tucker, Georgia 30084
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Chicago, Illinois 60607
Chicago, Illinois 60607
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Winfield, Illinois 60190
Winfield, Illinois 60190
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Valparaiso, Indiana 46383
Valparaiso, Indiana 46383
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Sioux City, Iowa 51106
Sioux City, Iowa 51106
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Newton, Kansas 67114
Newton, Kansas 67114
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Wichita, Kansas 67218
Wichita, Kansas 67218
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Lexington, Kentucky 40503
Lexington, Kentucky 40503
Research Site
Paducah, Kentucky 42001
Paducah, Kentucky 42001
Research Site
Lafayette, Louisiana 70508
Lafayette, Louisiana 70508
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Monroe, Louisiana 71201
Monroe, Louisiana 71201
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Shreveport, Louisiana 71105
Shreveport, Louisiana 71105
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Zachary, Louisiana 70791
Zachary, Louisiana 70791
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Oxon Hill, Maryland 20745
Oxon Hill, Maryland 20745
Research Site
Boston, Massachusetts 02115
Boston, Massachusetts 02115
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Ann Arbor, Michigan 48109
Ann Arbor, Michigan 48109
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Flint, Michigan 48504
Flint, Michigan 48504
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Southfield, Michigan 48034
Southfield, Michigan 48034
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Southfield, Michigan 48075
Southfield, Michigan 48075
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Gulfport, Mississippi 39503
Gulfport, Mississippi 39503
Research Site
Olive Branch, Mississippi 38654
Olive Branch, Mississippi 38654
Research Site
Kansas City, Missouri 64116
Kansas City, Missouri 64116
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Saint Louis, Missouri 63104
Saint Louis, Missouri 63104
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Saint Louis, Missouri 63136
Saint Louis, Missouri 63136
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Missoula, Montana 59808
Missoula, Montana 59808
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Fremont, Nebraska 68025
Fremont, Nebraska 68025
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Grand Island, Nebraska 68803
Grand Island, Nebraska 68803
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Omaha, Nebraska 68134
Omaha, Nebraska 68134
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Las Vegas, Nevada 89101
Las Vegas, Nevada 89101
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Las Vegas, Nevada 89121
Las Vegas, Nevada 89121
Research Site
Mullica Hill, New Jersey 08062
Mullica Hill, New Jersey 08062
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Toms River, New Jersey 08755
Toms River, New Jersey 08755
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Albany, New York 12205
Albany, New York 12205
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Bronx, New York 10455
Bronx, New York 10455
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Brooklyn, New York 11220
Brooklyn, New York 11220
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Massapequa, New York 11758
Massapequa, New York 11758
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New Windsor, New York 12553
New Windsor, New York 12553
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New York, New York 10036
New York, New York 10036
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New York, New York 10065
New York, New York 10065
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Greensboro, North Carolina 27405
Greensboro, North Carolina 27405
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Greenville, North Carolina 27834
Greenville, North Carolina 27834
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Huntersville, North Carolina 28078
Huntersville, North Carolina 28078
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Morehead City, North Carolina 28557
Morehead City, North Carolina 28557
Research Site
Raleigh, North Carolina 27612
Raleigh, North Carolina 27612
Research Site
Statesville, North Carolina 28625
Statesville, North Carolina 28625
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Wilmington, North Carolina 28401
Wilmington, North Carolina 28401
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Winston-Salem, North Carolina 27104
Winston-Salem, North Carolina 27104
Research Site
Beavercreek, Ohio 45431
Beavercreek, Ohio 45431
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Blue Ash, Ohio 45242
Blue Ash, Ohio 45242
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Cleveland, Ohio 44130
Cleveland, Ohio 44130
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Columbus, Ohio 43215
Columbus, Ohio 43215
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Columbus, Ohio 43235
Columbus, Ohio 43235
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Marion, Ohio 43302
Marion, Ohio 43302
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Norman, Oklahoma 73071
Norman, Oklahoma 73071
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Oklahoma City, Oklahoma 73134
Oklahoma City, Oklahoma 73134
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Tulsa, Oklahoma 74133
Tulsa, Oklahoma 74133
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Grants Pass, Oregon 97527
Grants Pass, Oregon 97527
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Medford, Oregon 97504
Medford, Oregon 97504
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Camp Hill, Pennsylvania 17011
Camp Hill, Pennsylvania 17011
Research Site
Philadelphia, Pennsylvania 19107
Philadelphia, Pennsylvania 19107
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Philadelphia, Pennsylvania 19140
Philadelphia, Pennsylvania 19140
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Anderson, South Carolina 29621
Anderson, South Carolina 29621
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Charleston, South Carolina 29414
Charleston, South Carolina 29414
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Gaffney, South Carolina 29340
Gaffney, South Carolina 29340
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Spartanburg, South Carolina 29303
Spartanburg, South Carolina 29303
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Union, South Carolina 29379
Union, South Carolina 29379
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Rapid City, South Dakota 57701
Rapid City, South Dakota 57701
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Sioux Falls, South Dakota 57104
Sioux Falls, South Dakota 57104
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Chattanooga, Tennessee 37421
Chattanooga, Tennessee 37421
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Franklin, Tennessee 37067
Franklin, Tennessee 37067
Research Site
Tullahoma, Tennessee 37388
Tullahoma, Tennessee 37388
Research Site
Abilene, Texas 79606
Abilene, Texas 79606
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Brownsville, Texas 78520
Brownsville, Texas 78520
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Dallas, Texas 75225
Dallas, Texas 75225
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Dallas, Texas 75235
Dallas, Texas 75235
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Dallas, Texas 75254
Dallas, Texas 75254
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El Paso, Texas 79902
El Paso, Texas 79902
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Forney, Texas 75126
Forney, Texas 75126
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Georgetown, Texas 78633
Georgetown, Texas 78633
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Houston, Texas 77002
Houston, Texas 77002
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Houston, Texas 77024
Houston, Texas 77024
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Houston, Texas 77079
Houston, Texas 77079
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Houston, Texas 77084
Houston, Texas 77084
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Houston, Texas 77089
Houston, Texas 77089
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Katy, Texas 77450
Katy, Texas 77450
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Kingwood, Texas 77339
Kingwood, Texas 77339
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McAllen, Texas 78504
McAllen, Texas 78504
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McKinney, Texas 75069
McKinney, Texas 75069
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Paris, Texas 75462
Paris, Texas 75462
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Plano, Texas 75024
Plano, Texas 75024
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Plano, Texas 75093
Plano, Texas 75093
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Waco, Texas 76708
Waco, Texas 76708
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Wichita Falls, Texas 76308
Wichita Falls, Texas 76308
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Wylie, Texas 75098
Wylie, Texas 75098
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Ogden, Utah 84405
Ogden, Utah 84405
Research Site
West Valley City, Utah 84120
West Valley City, Utah 84120
Research Site
Newport News, Virginia 23606
Newport News, Virginia 23606
Research Site
Norfolk, Virginia 23504
Norfolk, Virginia 23504
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Portsmouth, Virginia 23703
Portsmouth, Virginia 23703
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Richmond, Virginia 23219
Richmond, Virginia 23219
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Richmond, Virginia 23226
Richmond, Virginia 23226
Research Site
Spokane, Washington 99218
Spokane, Washington 99218
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Cudahy, Wisconsin 53110
Cudahy, Wisconsin 53110
Research Site
Milwaukee, Wisconsin 53228
Milwaukee, Wisconsin 53228
Research Site
Milwaukee, Wisconsin 53295
Milwaukee, Wisconsin 53295
More Details
- NCT ID
- NCT06283966
- Status
- Recruiting
- Sponsor
- AstraZeneca
Study Contact
AstraZeneca Clinical Study Information Center1-877-240-9479
information.center@astrazeneca.com
Detailed Description
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.