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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

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	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

Recruiting Locations

Research Site
Athens, Alabama 35611

Research Site
Cullman, Alabama 35058

Research Site
Fairhope, Alabama 36532

Research Site
Mobile, Alabama 36608

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Gilbert, Arizona 85296

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Mesa, Arizona 85206

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Mesa, Arizona 85213

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Phoenix, Arizona 85040

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Tempe, Arizona 85281

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Tucson, Arizona 85710

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Canoga Park, California 91303

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Castroville, California 95012

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Garden Grove, California 92844

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Inglewood, California 90301

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La Mesa, California 91942

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La Palma, California 90623

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Lomita, California 90717

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Long Beach, California 90815

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Newport Beach, California 92660

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Newport Beach, California 92663

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Pomona, California 91768

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Sacramento, California 95823

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Sacramento, California 95831

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San Diego, California 92111

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Tarzana, California 91356

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Thousand Oaks, California 91360

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Vista, California 92081

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Westminster, California 92683

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Aurora, Colorado 80012

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Denver, Colorado 80228

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Englewood, Colorado 80110

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Boynton Beach, Florida 33435

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Bradenton, Florida 34209

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Cape Coral, Florida 33990

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Clearwater, Florida 33756

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Clearwater, Florida 33765

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Crystal River, Florida 34429

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Cutler Bay, Florida 33189

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Edgewater, Florida 32132

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Fort Lauderdale, Florida 33308

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Fort Myers, Florida 33912

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Hialeah, Florida 33012

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Hialeah, Florida 33013

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Hollywood, Florida 33024

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Homestead, Florida 33032

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Kissimmee, Florida 34746

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Lake City, Florida 32055

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Lake Worth, Florida 33467

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Lakeland, Florida 33805

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Lakeland, Florida 33813

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Miami Lakes, Florida 33014

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Miami, Florida 33155

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Miami, Florida 33175

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Naples, Florida 34102

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Ocala, Florida 34470

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Orlando, Florida 32807

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Orlando, Florida 32819

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Orlando, Florida 32825

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Ormond Beach, Florida 32174

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Pembroke Pines, Florida 33024

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Plantation, Florida 33324

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Saint Petersburg, Florida 33713

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Sun City Center, Florida 33573

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Tamarac, Florida 33321

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Tampa, Florida 33606

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Tampa, Florida 33607

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Tampa, Florida 33625

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Atlanta, Georgia 30349

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Savannah, Georgia 31406

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Tucker, Georgia 30084

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Chicago, Illinois 60607

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Winfield, Illinois 60190

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Valparaiso, Indiana 46383

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Sioux City, Iowa 51106

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Newton, Kansas 67114

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Wichita, Kansas 67218

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Lexington, Kentucky 40503

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Paducah, Kentucky 42001

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Lafayette, Louisiana 70508

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Monroe, Louisiana 71201

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Shreveport, Louisiana 71105

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Zachary, Louisiana 70791

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Oxon Hill, Maryland 20745

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Boston, Massachusetts 02115

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Ann Arbor, Michigan 48109

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Flint, Michigan 48504

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Southfield, Michigan 48034

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Southfield, Michigan 48075

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Gulfport, Mississippi 39503

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Olive Branch, Mississippi 38654

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Kansas City, Missouri 64116

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Saint Louis, Missouri 63104

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Saint Louis, Missouri 63136

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Missoula, Montana 59808

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Fremont, Nebraska 68025

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Grand Island, Nebraska 68803

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Omaha, Nebraska 68134

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Las Vegas, Nevada 89101

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Las Vegas, Nevada 89121

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Mullica Hill, New Jersey 08062

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Toms River, New Jersey 08755

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Albany, New York 12205

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Bronx, New York 10455

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Brooklyn, New York 11220

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Massapequa, New York 11758

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New Windsor, New York 12553

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New York, New York 10036

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New York, New York 10065

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Greensboro, North Carolina 27405

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Greenville, North Carolina 27834

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Huntersville, North Carolina 28078

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Morehead City, North Carolina 28557

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Raleigh, North Carolina 27612

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Statesville, North Carolina 28625

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Wilmington, North Carolina 28401

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Winston-Salem, North Carolina 27104

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Beavercreek, Ohio 45431

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Blue Ash, Ohio 45242

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Cleveland, Ohio 44130

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Columbus, Ohio 43215

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Columbus, Ohio 43235

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Marion, Ohio 43302

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Norman, Oklahoma 73071

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Oklahoma City, Oklahoma 73134

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Tulsa, Oklahoma 74133

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Grants Pass, Oregon 97527

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Medford, Oregon 97504

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Camp Hill, Pennsylvania 17011

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Philadelphia, Pennsylvania 19107

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Philadelphia, Pennsylvania 19140

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Anderson, South Carolina 29621

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Charleston, South Carolina 29414

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Gaffney, South Carolina 29340

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Spartanburg, South Carolina 29303

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Union, South Carolina 29379

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Rapid City, South Dakota 57701

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Sioux Falls, South Dakota 57104

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Chattanooga, Tennessee 37421

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Franklin, Tennessee 37067

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Tullahoma, Tennessee 37388

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Abilene, Texas 79606

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Brownsville, Texas 78520

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Dallas, Texas 75225

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Dallas, Texas 75235

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Dallas, Texas 75254

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El Paso, Texas 79902

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Forney, Texas 75126

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Georgetown, Texas 78633

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Houston, Texas 77002

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Houston, Texas 77024

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Houston, Texas 77079

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Houston, Texas 77084

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Houston, Texas 77089

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Katy, Texas 77450

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Kingwood, Texas 77339

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McAllen, Texas 78504

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McKinney, Texas 75069

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Paris, Texas 75462

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Plano, Texas 75024

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Plano, Texas 75093

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Waco, Texas 76708

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Wichita Falls, Texas 76308

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Wylie, Texas 75098

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Ogden, Utah 84405

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West Valley City, Utah 84120

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Newport News, Virginia 23606

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Norfolk, Virginia 23504

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Portsmouth, Virginia 23703

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Richmond, Virginia 23219

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Richmond, Virginia 23226

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Spokane, Washington 99218

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Cudahy, Wisconsin 53110

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Milwaukee, Wisconsin 53228

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Milwaukee, Wisconsin 53295

More Details

NCT ID: NCT06283966
Status: Recruiting
Sponsor: AstraZeneca

Study Contact

AstraZeneca Clinical Study Information Center
1-877-240-9479
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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.