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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 Sex: 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
Cullman 4057835, Alabama 4829764 35058

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Mobile 4076598, Alabama 4829764 36608

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Gilbert 5295903, Arizona 5551752 85296

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Mesa 5304391, Arizona 5551752 85206

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Mesa 5304391, Arizona 5551752 85213

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Tempe 5317058, Arizona 5551752 85281

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Tucson 5318313, Arizona 5551752 85710

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Tucson 5318313, Arizona 5551752 85715

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Castroville 5334937, California 5332921 95012

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Garden Grove 5351515, California 5332921 92844

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Inglewood 5359488, California 5332921 90301

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La Mesa 5363990, California 5332921 91942

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La Palma 5364022, California 5332921 90623

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Lomita 5367767, California 5332921 90717

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Long Beach 5367929, California 5332921 90815

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Newport Beach 5376890, California 5332921 92660

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Newport Beach 5376890, California 5332921 92663

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Pomona 5384170, California 5332921 91768

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Sacramento 5389489, California 5332921 95823

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Sacramento 5389489, California 5332921 95831

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Tarzana 5401143, California 5332921 91356

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Thousand Oaks 5402405, California 5332921 91360

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Vista 5406602, California 5332921 92081

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Aurora 5412347, Colorado 5417618 80012

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Denver 5419384, Colorado 5417618 80228

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Boynton Beach 4148677, Florida 4155751 33435

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Bradenton 4148708, Florida 4155751 34209

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Cape Coral 4149962, Florida 4155751 33990

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Clearwater 4151316, Florida 4155751 33756

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Clearwater 4151316, Florida 4155751 33765

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Crystal River 4152487, Florida 4155751 34429

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Edgewater 4154205, Florida 4155751 32132

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Fort Lauderdale 4155966, Florida 4155751 33308

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Hollywood 4158928, Florida 4155751 33024

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Homestead 4159050, Florida 4155751 33032

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Kissimmee 4160983, Florida 4155751 34746

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Lake City 4161187, Florida 4155751 32055

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Lake Worth 4161422, Florida 4155751 33467

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Lakeland 4161438, Florida 4155751 33805

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Lakeland 4161438, Florida 4155751 33813

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Miami 4164138, Florida 4155751 33155

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Miami 4164138, Florida 4155751 33175

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Miami Lakes 4164186, Florida 4155751 33014

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Naples 4165565, Florida 4155751 34102

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Ocala 4166673, Florida 4155751 34470

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Orlando 4167147, Florida 4155751 32807

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Orlando 4167147, Florida 4155751 32819

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Orlando 4167147, Florida 4155751 32825

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Ormond Beach 4167178, Florida 4155751 32174

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Pembroke Pines 4168139, Florida 4155751 33024

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Plantation 4168782, Florida 4155751 33324

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St. Petersburg 4171563, Florida 4155751 33713

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Tamarac 4174738, Florida 4155751 33321

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Tampa 4174757, Florida 4155751 33606

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Tampa 4174757, Florida 4155751 33607

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Savannah 4221552, Georgia 4197000 31406

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Tucker 4227213, Georgia 4197000 30084

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Chicago 4887398, Illinois 4896861 60607

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Winfield 4916826, Illinois 4896861 60190

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Valparaiso 4927537, Indiana 4921868 46383

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Sioux City 4876523, Iowa 4862182 51106

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Wichita 4281730, Kansas 4273857 67218

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Lexington 4297983, Kentucky 6254925 40503

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Lafayette 4330145, Louisiana 4331987 70508

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Monroe 4333669, Louisiana 4331987 71201

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Shreveport 4341513, Louisiana 4331987 71105

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Zachary 4346788, Louisiana 4331987 70791

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Oxon Hill 4364759, Maryland 4361885 20745

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Boston 4930956, Massachusetts 6254926 02115

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Ann Arbor 4984247, Michigan 5001836 48109

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Flint 4992982, Michigan 5001836 48504

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Southfield 5010636, Michigan 5001836 48034

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Southfield 5010636, Michigan 5001836 48075

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Gulfport 4428667, Mississippi 4436296 39503

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Olive Branch 4439869, Mississippi 4436296 38654

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St Louis 4407066, Missouri 4398678 63104

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Missoula 5666639, Montana 5667009 59808

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Fremont 5068725, Nebraska 5073708 68025

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Grand Island 5069297, Nebraska 5073708 68803

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Las Vegas 5506956, Nevada 5509151 89101

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Las Vegas 5506956, Nevada 5509151 89121

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Mullica Hill 4503195, New Jersey 5101760 08062

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Toms River 4504476, New Jersey 5101760 08755

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Albany 5106834, New York 5128638 12205

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Massapequa 5126183, New York 5128638 11758

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New Windsor 5128577, New York 5128638 12553

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New York 5128581, New York 5128638 10036

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New York 5128581, New York 5128638 10065

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The Bronx 5110266, New York 5128638 10455

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Greensboro 4469146, North Carolina 4482348 27405

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Greenville 4469160, North Carolina 4482348 27834

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Huntersville 4472370, North Carolina 4482348 28078

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Morehead City 4480153, North Carolina 4482348 28557

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Statesville 4493316, North Carolina 4482348 28625

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Winston-Salem 4499612, North Carolina 4482348 27104

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Blue Ash 4506754, Ohio 5165418 45242

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Columbus 4509177, Ohio 5165418 43215

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Marion 5161902, Ohio 5165418 43302

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Norman 4543762, Oklahoma 4544379 73071

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Oklahoma City 4544349, Oklahoma 4544379 73134

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Tulsa 4553433, Oklahoma 4544379 74133

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Medford 5740099, Oregon 5744337 97504

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Camp Hill 5182928, Pennsylvania 6254927 17011

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Philadelphia 4560349, Pennsylvania 6254927 19107

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Philadelphia 4560349, Pennsylvania 6254927 19140

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Anderson 4569298, South Carolina 4597040 29621

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Charleston 4574324, South Carolina 4597040 29414

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Gaffney 4579418, South Carolina 4597040 29340

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Spartanburg 4597200, South Carolina 4597040 29303

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Union 4599214, South Carolina 4597040 29379

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Rapid City 5768233, South Dakota 5769223 57701

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Sioux Falls 5231851, South Dakota 5769223 57104

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Chattanooga 4612862, Tennessee 4662168 37421

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Franklin 4623560, Tennessee 4662168 37067

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Tullahoma 4663494, Tennessee 4662168 37388

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Abilene 4669635, Texas 4736286 79606

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Brownsville 4676740, Texas 4736286 78520

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Dallas 4684888, Texas 4736286 75254

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El Paso 5520993, Texas 4736286 79902

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Forney 4691833, Texas 4736286 75126

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Houston 4699066, Texas 4736286 77002

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Houston 4699066, Texas 4736286 77079

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Houston 4699066, Texas 4736286 77089

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Kingwood 7534469, Texas 4736286 77339

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McAllen 4709796, Texas 4736286 78504

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McKinney 4710178, Texas 4736286 75069

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Paris 4717560, Texas 4736286 75462

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Plano 4719457, Texas 4736286 75093

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Waco 4739526, Texas 4736286 76708

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Wylie 4743275, Texas 4736286 75098

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Ogden 5779206, Utah 5549030 84405

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West Valley City 5784607, Utah 5549030 84120

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Norfolk 4776222, Virginia 6254928 23504

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Richmond 4781708, Virginia 6254928 23219

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Suffolk 4788158, Virginia 6254928 23435

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Spokane 5811696, Washington 5815135 99218

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Cudahy 5249871, Wisconsin 5279468 53110

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Milwaukee 5263045, Wisconsin 5279468 53228

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.