A Study Evaluating the Efficacy of Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dosed Inhaler on Cardiopulmonary Outcomes in Chronic Obstructive Pulmonary Disease
A Randomized, Double-blind, Parallel Group, Multi-center, Phase III Study to Assess the Efficacy of Budesonide, Glycopyrronium, and Formoterol Fumarate Metered Dose Inhaler Relative to Glycopyrronium and Formoterol Fumarate MDI on Cardiopulmonary Outcomes in Chronic Obstructive Pulmonary Disease (THARROS)
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 40 Years to 80 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study compares a three-drug inhaler with a two-drug inhaler to see how they affect heart and lung health. It is for adults with COPD, a long-term lung disease that makes breathing hard, who have a higher risk of heart and lung problems.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be 40 to 80 years old and able to sign a form agreeing to join the study.
- Have COPD confirmed by a breathing test after taking medicine to open the airways. The test ratio, called FEV1/FVC, must be below 70%.
- Smoke now or have quit at least 6 months ago. Have smoked at least 10 pack-years—for example, 1 pack a day for 10 years.
- Have a blood eosinophil count of at least 100 cells/mm³. Eosinophils are a type of white blood cell.
- Score at least 10 on the CAT, a survey about COPD symptoms.
- Have heart or blood vessel disease; a combination of risk factors such as high blood pressure, diabetes, kidney disease, unhealthy blood fats, or obesity; a high risk score; or calcium buildup in heart arteries seen on a CT scan.
- Show correct inhaler use at the first two visits. Be willing and able to change COPD medicines as required and complete study visits and tests.
- Women who can become pregnant must have a negative blood pregnancy test at the first visit and use highly effective birth control. Other women must be past menopause or permanently unable to become pregnant through surgery.
Who can't join
- Have had active asthma in the past 5 years, have both asthma and COPD, or have another long-term lung disease besides COPD. Asthma only in childhood or the teen years is allowed.
- Have kidney failure needing dialysis or other kidney replacement treatment; have had or be listed for a heart or lung transplant; or have a heart pump device or expect one within 3 months.
- Have a history of lung cancer or lung cancer treatment within the past 5 years. Also excluded are other life-threatening illnesses, apart from COPD or heart and blood vessel disease, that may prevent study completion and shorten expected life to under 5 years.
- Have had a heart attack, unstable chest pain, or a dangerous or unstable heart rhythm needing treatment in the past 8 weeks. Pneumonia or a moderate or severe COPD flare-up must have cleared at least 8 weeks before the first visit.
- Have used regular inhaled steroid treatment in the past 12 months, cannot stop medicines banned by the study, or are allergic to any study inhaler ingredient.
- Have received treatment in another study too recently—within 30 days or longer, depending on how long the treatment stays in the body—or have already been assigned to a treatment group in this study.
- Help plan or run this study, or the study doctor thinks you are unlikely to follow its rules and visits.
- Be pregnant or breastfeeding.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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 sites (235)
AL
- Research Site · Athens, AL 35611More trials in Athens
- Research Site · Cullman, AL 35058More trials in Cullman
- Research Site · Fairhope, AL 36532More trials in Fairhope
- Research Site · Huntsville, AL 35801More trials in Huntsville
- Research Site · Mobile, AL 36608More trials in Mobile
- Research Site · Sheffield, AL 35660More trials in Sheffield
AZ
- Research Site · Gilbert, AZ 85296More trials in Gilbert
- Research Site · Glendale, AZ 85308More trials in Glendale
- Research Site · Mesa, AZ 85206More trials in Mesa
- Research Site · Mesa, AZ 85213More trials in Mesa
- Research Site · Phoenix, AZ 85006More trials in Phoenix
- Research Site · Tempe, AZ 85281More trials in Tempe
- Research Site · Tempe, AZ 85283More trials in Tempe
- Research Site · Tucson, AZ 85710More trials in Tucson
- Research Site · Tucson, AZ 85715More trials in Tucson
CA
- Research Site · Apple Valley, CA 92307More trials in Apple Valley
- Research Site · Canoga Park, CA 91303More trials in Canoga Park
- Research Site · Castroville, CA 95012More trials in Castroville
- Research Site · Garden Grove, CA 92844More trials in Garden Grove
- Research Site · Gardena, CA 90247More trials in Gardena
- Research Site · Inglewood, CA 90301More trials in Inglewood
- Research Site · La Mesa, CA 91942More trials in La Mesa
- Research Site · La Palma, CA 90623More trials in La Palma
- Research Site · Lomita, CA 90717More trials in Lomita
- Research Site · Long Beach, CA 90815More trials in Long Beach
- Research Site · Los Alamitos, CA 90720More trials in Los Alamitos
- Research Site · Mission Viejo, CA 92691More trials in Mission Viejo
- Research Site · Newport Beach, CA 92663More trials in Newport Beach
- Research Site · North Hollywood, CA 91602More trials in North Hollywood
- Research Site · Pomona, CA 91768More trials in Pomona
- Research Site · Sacramento, CA 95823More trials in Sacramento
- Research Site · Sacramento, CA 95831More trials in Sacramento
- Research Site · San Bernardino, CA 92408More trials in San Bernardino
- Research Site · San Diego, CA 92111More trials in San Diego
- Research Site · San Dimas, CA 91773More trials in San Dimas
- Research Site · Santa Ana, CA 92704More trials in Santa Ana
- Research Site · Tarzana, CA 91356More trials in Tarzana
- Research Site · Thousand Oaks, CA 91360More trials in Thousand Oaks
- Research Site · Van Nuys, CA 91405More trials in Van Nuys
- Research Site · Vista, CA 92081More trials in Vista
- Research Site · Westminster, CA 92683More trials in Westminster
CO
- Research Site · Aurora, CO 80012More trials in Aurora
- Research Site · Denver, CO 80228More trials in Denver
- Research Site · Englewood, CO 80110More trials in Englewood
DC
- Research Site · Washington D.C., DC 20016More trials in Washington D.C.
FL
- Research Site · Boynton Beach, FL 33435More trials in Boynton Beach
- Research Site · Bradenton, FL 34209More trials in Bradenton
- Research Site · Cape Coral, FL 33990More trials in Cape Coral
- Research Site · Clearwater, FL 33756More trials in Clearwater
- Research Site · Clearwater, FL 33765More trials in Clearwater
- Research Site · Crystal River, FL 34429More trials in Crystal River
- Research Site · Cutler Bay, FL 33189More trials in Cutler Bay
- Research Site · Edgewater, FL 32132More trials in Edgewater
- Research Site · Fort Lauderdale, FL 33308More trials in Fort Lauderdale
- Research Site · Fort Myers, FL 33912More trials in Fort Myers
- Research Site · Hialeah, FL 33012More trials in Hialeah
- Research Site · Hialeah, FL 33013More trials in Hialeah
- Research Site · Hollywood, FL 33024More trials in Hollywood
- Research Site · Homestead, FL 33033More trials in Homestead
- Research Site · Kissimmee, FL 34741More trials in Kissimmee
- Research Site · Kissimmee, FL 34746More trials in Kissimmee
- Research Site · Lake City, FL 32055More trials in Lake City
- Research Site · Lake City, FL 32055More trials in Lake City
- Research Site · Lake Worth, FL 33467More trials in Lake Worth
- Research Site · Lakeland, FL 33805More trials in Lakeland
- Research Site · Lakeland, FL 33813More trials in Lakeland
- Research Site · Loxahatchee Groves, FL 33470More trials in Loxahatchee Groves
- Research Site · Miami, FL 33155More trials in Miami
- Research Site · Miami, FL 33175More trials in Miami
- Research Site · Miami, FL 33175More trials in Miami
- Research Site · Miami Lakes, FL 33016More trials in Miami Lakes
- Research Site · Naples, FL 34102More trials in Naples
- Research Site · Ocala, FL 34470More trials in Ocala
- Research Site · Orlando, FL 32807More trials in Orlando
- Research Site · Orlando, FL 32819More trials in Orlando
- Research Site · Orlando, FL 32825More trials in Orlando
- Research Site · Ormond Beach, FL 32174More trials in Ormond Beach
- Research Site · Pembroke Pines, FL 33024More trials in Pembroke Pines
- Research Site · Plantation, FL 33324More trials in Plantation
- Research Site · St. Petersburg, FL 33713More trials in St. Petersburg
- Research Site · St. Petersburg, FL 33713More trials in St. Petersburg
- Research Site · Sun City Center, FL 33573More trials in Sun City Center
- Research Site · Tamarac, FL 33321More trials in Tamarac
- Research Site · Tamarac, FL 33321More trials in Tamarac
- Research Site · Tampa, FL 33606More trials in Tampa
- Research Site · Tampa, FL 33607More trials in Tampa
- Research Site · Tampa, FL 33625More trials in Tampa
GA
- Research Site · Fayetteville, GA 30214More trials in Fayetteville
- Research Site · Peachtree Corners, GA 30092More trials in Peachtree Corners
- Research Site · Savannah, GA 31406More trials in Savannah
- Research Site · Tucker, GA 30084More trials in Tucker
IA
- Research Site · Sioux City, IA 51106More trials in Sioux City
ID
- Research Site · Boise, ID 83706More trials in Boise
IL
- Research Site · Chicago, IL 60607More trials in Chicago
- Research Site · Winfield, IL 60190More trials in Winfield
IN
- Research Site · Valparaiso, IN 46383More trials in Valparaiso
KS
- Research Site · Newton, KS 67114More trials in Newton
- Research Site · Wichita, KS 67218More trials in Wichita
KY
- Research Site · Lexington, KY 40503More trials in Lexington
- Research Site · Paducah, KY 42001More trials in Paducah
LA
- Research Site · Lafayette, LA 70508More trials in Lafayette
- Research Site · Monroe, LA 71201More trials in Monroe
- Research Site · Shreveport, LA 71105More trials in Shreveport
- Research Site · Zachary, LA 70791More trials in Zachary
MA
- Research Site · Boston, MA 02115More trials in Boston
MD
- Research Site · Glen Burnie, MD 21061More trials in Glen Burnie
- Research Site · Oxon Hill, MD 20745More trials in Oxon Hill
- Research Site · Potomac, MD 20854More trials in Potomac
MI
- Research Site · Ann Arbor, MI 48109More trials in Ann Arbor
- Research Site · Flint, MI 48504More trials in Flint
- Research Site · Southfield, MI 48034More trials in Southfield
- Research Site · Southfield, MI 48075More trials in Southfield
MO
- Research Site · Kansas City, MO 64116More trials in Kansas City
- Research Site · Liberty, MO 64068More trials in Liberty
- Research Site · St Louis, MO 63104More trials in St Louis
- Research Site · St Louis, MO 63136More trials in St Louis
MS
- Research Site · Gulfport, MS 39503More trials in Gulfport
- Research Site · Olive Branch, MS 38654More trials in Olive Branch
MT
- Research Site · Missoula, MT 59808More trials in Missoula
NC
- Research Site · Fayetteville, NC 28303More trials in Fayetteville
- Research Site · Greensboro, NC 27405More trials in Greensboro
- Research Site · Greenville, NC 27834More trials in Greenville
- Research Site · Huntersville, NC 28078More trials in Huntersville
- Research Site · Morehead City, NC 28557More trials in Morehead City
- Research Site · Raleigh, NC 27612More trials in Raleigh
- Research Site · Salisbury, NC 28144More trials in Salisbury
- Research Site · Statesville, NC 28625More trials in Statesville
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- Research Site · Winston-Salem, NC 27104More trials in Winston-Salem
NE
- Research Site · Fremont, NE 68025More trials in Fremont
- Research Site · Grand Island, NE 68803More trials in Grand Island
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- Research Site · Omaha, NE 68134More trials in Omaha
NJ
- Research Site · Lawrence, NJ 08648More trials in Lawrence
- Research Site · Mullica Hill, NJ 08062More trials in Mullica Hill
- Research Site · Toms River, NJ 08755More trials in Toms River
- Research Site · Union City, NJ 07087More trials in Union City
NM
- Research Site · Albuquerque, NM 87109More trials in Albuquerque
NV
- Research Site · Las Vegas, NV 89101More trials in Las Vegas
- Research Site · Las Vegas, NV 89102More trials in Las Vegas
- Research Site · Las Vegas, NV 89119More trials in Las Vegas
- Research Site · Las Vegas, NV 89121More trials in Las Vegas
NY
- Research Site · Albany, NY 12205More trials in Albany
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- Research Site · Bronxville, NY 10708More trials in Bronxville
- Research Site · Brooklyn, NY 11220More trials in Brooklyn
- Research Site · Massapequa, NY 11758More trials in Massapequa
- Research Site · New Windsor, NY 12553More trials in New Windsor
- Research Site · New York, NY 10036More trials in New York
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- Research Site · The Bronx, NY 10455More trials in The Bronx
- Research Site · Vestal, NY 13850More trials in Vestal
OH
- Research Site · Beavercreek, OH 45431More trials in Beavercreek
- Research Site · Blue Ash, OH 45242More trials in Blue Ash
- Research Site · Cleveland, OH 44130More trials in Cleveland
- Research Site · Columbus, OH 43215More trials in Columbus
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- Research Site · Marion, OH 43302More trials in Marion
- Research Site · Toledo, OH 43617More trials in Toledo
OK
- Research Site · Norman, OK 73071More trials in Norman
- Research Site · Oklahoma City, OK 73134More trials in Oklahoma City
- Research Site · Tulsa, OK 74133More trials in Tulsa
OR
- Research Site · Grants Pass, OR 97527More trials in Grants Pass
- Research Site · Medford, OR 97504More trials in Medford
- Research Site · Roseburg, OR 97471More trials in Roseburg
PA
- Research Site · Camp Hill, PA 17011More trials in Camp Hill
- Research Site · DuBois, PA 15801More trials in DuBois
- Research Site · Exton, PA 19341More trials in Exton
- Research Site · Philadelphia, PA 19107More trials in Philadelphia
- Research Site · Philadelphia, PA 19140More trials in Philadelphia
SC
- Research Site · Anderson, SC 29621More trials in Anderson
- Research Site · Charleston, SC 29414More trials in Charleston
- Research Site · Charleston, SC 29414More trials in Charleston
- Research Site · Columbia, SC 29201More trials in Columbia
- Research Site · Gaffney, SC 29340More trials in Gaffney
- Research Site · Spartanburg, SC 29303More trials in Spartanburg
- Research Site · Union, SC 29379More trials in Union
SD
- Research Site · Pierre, SD 57501More trials in Pierre
- Research Site · Rapid City, SD 57701More trials in Rapid City
- Research Site · Sioux Falls, SD 57104More trials in Sioux Falls
TN
- Research Site · Chattanooga, TN 37421More trials in Chattanooga
- Research Site · Elizabethton, TN 37643More trials in Elizabethton
- Research Site · Franklin, TN 37067More trials in Franklin
- Research Site · Morristown, TN 37813More trials in Morristown
- Research Site · Tullahoma, TN 37388More trials in Tullahoma
TX
- Research Site · Abilene, TX 79606More trials in Abilene
- Research Site · Amarillo, TX 79106More trials in Amarillo
- Research Site · Austin, TX 78704More trials in Austin
- Research Site · Brownsville, TX 78520More trials in Brownsville
- Research Site · Dallas, TX 75225More trials in Dallas
- Research Site · Dallas, TX 75235More trials in Dallas
- Research Site · Dallas, TX 75254More trials in Dallas
- Research Site · El Paso, TX 79902More trials in El Paso
- Research Site · El Paso, TX 79902More trials in El Paso
- Research Site · Forney, TX 75126More trials in Forney
- Research Site · Georgetown, TX 78633More trials in Georgetown
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- Research Site · Houston, TX 77074More trials in Houston
- Research Site · Houston, TX 77079More trials in Houston
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- Research Site · Houston, TX 77089More trials in Houston
- Research Site · Houston, TX 77207More trials in Houston
- Research Site · Katy, TX 77450More trials in Katy
- Research Site · Katy, TX 77493More trials in Katy
- Research Site · Kerrville, TX 78028More trials in Kerrville
- Research Site · Kingwood, TX 77339More trials in Kingwood
- Research Site · Lewisville, TX 75057More trials in Lewisville
- Research Site · McAllen, TX 78504More trials in McAllen
- Research Site · McKinney, TX 75069More trials in McKinney
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- Research Site · Plano, TX 75024More trials in Plano
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UT
- Research Site · Bountiful, UT 84010More trials in Bountiful
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VA
- Research Site · Newport News, VA 23606More trials in Newport News
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WA
- Research Site · Spokane, WA 99218More trials in Spokane
WI
- Research Site · Cudahy, WI 53110More trials in Cudahy
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WV
- Research Site · Morgantown, WV 26505More trials in Morgantown