A Study Evaluating the Efficacy of Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dosed Inhaler on Cardiopulmonary Outcomes in Chronic Obstructive Pulmonary Disease
Key facts
- Where
- Abilene, Albany, Albuquerque, Amarillo, Anderson, Ann Arbor, Apple Valley, Athens, Aurora, Austin, Beavercreek, Blue Ash, Boise, Boston, Bountiful, Boynton Beach, Bradenton, Bronxville, Brooklyn, Brownsville, Camp Hill, Canoga Park, Cape Coral, Castroville, Charleston, Chattanooga, Chicago, Clearwater, Cleveland, Columbia, Columbus, Crystal River, Cudahy, Cullman, Cutler Bay, Dallas, Denver, DuBois, Edgewater, El Paso, Elizabethton, Englewood, Exton, Fairhope, Fayetteville, Flint, Forney, Fort Lauderdale, Fort Myers, Franklin, Fremont, Gaffney, Garden Grove, Gardena, Georgetown, Gilbert, Glen Burnie, Glendale, Grand Island, Grants Pass, Greensboro, Greenville, Gulfport, Hialeah, Hollywood, Homestead, Houston, Huntersville, Huntsville, Inglewood, Kansas City, Katy, Kerrville, Kingwood, Kissimmee, La Mesa, La Palma, Lafayette, Lake City, Lake Worth, Lakeland, Las Vegas, Lawrence, Lewisville, Lexington, Liberty, Lincoln, Lomita, Long Beach, Los Alamitos, Loxahatchee Groves, Marion, Massapequa, McAllen, McKinney, Medford, Mesa, Miami, Miami Lakes, Milwaukee, Mission Viejo, Missoula, Mobile, Monroe, Morehead City, Morgantown, Morristown, Mullica Hill, Naples, New Windsor, New York, Newport Beach, Newport News, Newton, Norfolk, Norman, North Hollywood, Ocala, Ogden, Oklahoma City, Olive Branch, Omaha, Orlando, Ormond Beach, Oxon Hill, Paducah, Paris, Peachtree Corners, Pembroke Pines, Philadelphia, Phoenix, Pierre, Plano, Plantation, Pomona, Potomac, Raleigh, Rapid City, Richmond, Roseburg, Sacramento, Salisbury, Salt Lake City, San Bernardino, San Diego, San Dimas, Santa Ana, Savannah, Sheffield, Shreveport, Sioux City, Sioux Falls, Southfield, Spartanburg, Spokane, St Louis, St. Petersburg, Statesville, Suffolk, Sun City Center, Tamarac, Tampa, Tarzana, Tempe, The Bronx, Thousand Oaks, Toledo, Toms River, Tucker, Tucson, Tullahoma, Tulsa, Union, Union City, Valparaiso, Van Nuys, Vestal, Victoria, Vista, Waco, Washington D.C., West Jordan, West Valley City, Westminster, Wichita, Wichita Falls, Wilmington, Winfield, Winston-Salem, Wylie, and Zachary, United StatesSee the 191 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 40 and 80 years old?
Source: NCT06283966, who can take part
Where in United States
- AbileneAbilene, United StatesTaking people
- AlbanyAlbany, United StatesTaking people
- AlbuquerqueAlbuquerque, United StatesNo longer taking part
- AmarilloAmarillo, United StatesNo longer taking part
- AndersonAnderson, United StatesTaking people
- Ann ArborAnn Arbor, United StatesTaking people
- Apple ValleyApple Valley, United StatesNo longer taking part
- AthensAthens, United StatesNo longer taking part
- AuroraAurora, United StatesTaking people
- AustinAustin, United StatesNo longer taking part
- BeavercreekBeavercreek, United StatesNo longer taking part
- Blue AshBlue Ash, United StatesTaking people
- BoiseBoise, United StatesNo longer taking part
- BostonBoston, United StatesTaking people
- BountifulBountiful, United StatesNo longer taking part
- Boynton BeachBoynton Beach, United StatesTaking people
- BradentonBradenton, United StatesTaking people
- BronxvilleBronxville, United StatesNo longer taking part
- BrooklynBrooklyn, United StatesNo longer taking part
- BrownsvilleBrownsville, United StatesTaking people
- Camp HillCamp Hill, United StatesTaking people
- Canoga ParkCanoga Park, United StatesNo longer taking part
- Cape CoralCape Coral, United StatesTaking people
- CastrovilleCastroville, United StatesTaking people
- CharlestonCharleston, United StatesTaking people
- ChattanoogaChattanooga, United StatesTaking people
- ChicagoChicago, United StatesTaking people
- ClearwaterClearwater, United StatesTaking people
- ClevelandCleveland, United StatesNo longer taking part
- ColumbiaColumbia, United StatesNo longer taking part
- ColumbusColumbus, United StatesTaking people
- Crystal RiverCrystal River, United StatesTaking people
- CudahyCudahy, United StatesTaking people
- CullmanCullman, United StatesTaking people
- Cutler BayCutler Bay, United StatesNo longer taking part
- DallasDallas, United StatesNo longer taking part
- DenverDenver, United StatesTaking people
- DuBoisDuBois, United StatesNo longer taking part
- EdgewaterEdgewater, United StatesTaking people
- El PasoEl Paso, United StatesNo longer taking part
- ElizabethtonElizabethton, United StatesNo longer taking part
- EnglewoodEnglewood, United StatesNo longer taking part
- ExtonExton, United StatesNo longer taking part
- FairhopeFairhope, United StatesNo longer taking part
- FayettevilleFayetteville, United StatesNo longer taking part
- FlintFlint, United StatesTaking people
- ForneyForney, United StatesTaking people
- Fort LauderdaleFort Lauderdale, United StatesTaking people
- Fort MyersFort Myers, United StatesNo longer taking part
- FranklinFranklin, United StatesTaking people
- FremontFremont, United StatesTaking people
- GaffneyGaffney, United StatesTaking people
- Garden GroveGarden Grove, United StatesTaking people
- GardenaGardena, United StatesNo longer taking part
- GeorgetownGeorgetown, United StatesNo longer taking part
- GilbertGilbert, United StatesTaking people
- Glen BurnieGlen Burnie, United StatesNo longer taking part
- GlendaleGlendale, United StatesNo longer taking part
- Grand IslandGrand Island, United StatesTaking people
- Grants PassGrants Pass, United StatesNo longer taking part
- GreensboroGreensboro, United StatesTaking people
- GreenvilleGreenville, United StatesTaking people
- GulfportGulfport, United StatesTaking people
- HialeahHialeah, United StatesNo longer taking part
- HollywoodHollywood, United StatesTaking people
- HomesteadHomestead, United StatesTaking people
- HoustonHouston, United StatesTaking people
- HuntersvilleHuntersville, United StatesTaking people
- HuntsvilleHuntsville, United StatesNo longer taking part
- InglewoodInglewood, United StatesTaking people
- Kansas CityKansas City, United StatesNo longer taking part
- KatyKaty, United StatesNo longer taking part
- KerrvilleKerrville, United StatesNo longer taking part
- KingwoodKingwood, United StatesTaking people
- KissimmeeKissimmee, United StatesNo longer taking part
- La MesaLa Mesa, United StatesTaking people
- La PalmaLa Palma, United StatesTaking people
- LafayetteLafayette, United StatesTaking people
- Lake CityLake City, United StatesNo longer taking part
- Lake WorthLake Worth, United StatesTaking people
- LakelandLakeland, United StatesTaking people
- Las VegasLas Vegas, United StatesTaking people
- LawrenceLawrence, United StatesNo longer taking part
- LewisvilleLewisville, United StatesNo longer taking part
- LexingtonLexington, United StatesTaking people
- LibertyLiberty, United StatesNo longer taking part
- LincolnLincoln, United StatesNo longer taking part
- LomitaLomita, United StatesTaking people
- Long BeachLong Beach, United StatesTaking people
- Los AlamitosLos Alamitos, United StatesNo longer taking part
- Loxahatchee GrovesLoxahatchee Groves, United StatesNo longer taking part
- MarionMarion, United StatesTaking people
- MassapequaMassapequa, United StatesTaking people
- McAllenMcAllen, United StatesTaking people
- McKinneyMcKinney, United StatesTaking people
- MedfordMedford, United StatesTaking people
- MesaMesa, United StatesTaking people
- MiamiMiami, United StatesTaking people
- Miami LakesMiami Lakes, United StatesTaking people
- MilwaukeeMilwaukee, United StatesTaking people
- Mission ViejoMission Viejo, United StatesTaking people
- MissoulaMissoula, United StatesTaking people
- MobileMobile, United StatesTaking people
- MonroeMonroe, United StatesTaking people
- Morehead CityMorehead City, United StatesTaking people
- MorgantownMorgantown, United StatesNo longer taking part
- MorristownMorristown, United StatesNo longer taking part
- Mullica HillMullica Hill, United StatesTaking people
- NaplesNaples, United StatesTaking people
- New WindsorNew Windsor, United StatesTaking people
- New YorkNew York, United StatesTaking people
- Newport BeachNewport Beach, United StatesTaking people
- Newport NewsNewport News, United StatesNo longer taking part
- NewtonNewton, United StatesNo longer taking part
- NorfolkNorfolk, United StatesTaking people
- NormanNorman, United StatesTaking people
- North HollywoodNorth Hollywood, United StatesNo longer taking part
- OcalaOcala, United StatesTaking people
- OgdenOgden, United StatesTaking people
- Oklahoma CityOklahoma City, United StatesTaking people
- Olive BranchOlive Branch, United StatesTaking people
- OmahaOmaha, United StatesNo longer taking part
- OrlandoOrlando, United StatesTaking people
- Ormond BeachOrmond Beach, United StatesTaking people
- Oxon HillOxon Hill, United StatesTaking people
- PaducahPaducah, United StatesNo longer taking part
- ParisParis, United StatesTaking people
- Peachtree CornersPeachtree Corners, United StatesNo longer taking part
- Pembroke PinesPembroke Pines, United StatesNo longer taking part
- PhiladelphiaPhiladelphia, United StatesTaking people
- PhoenixPhoenix, United StatesNo longer taking part
- PierrePierre, United StatesNo longer taking part
- PlanoPlano, United StatesNo longer taking part
- PlantationPlantation, United StatesTaking people
- PomonaPomona, United StatesTaking people
- PotomacPotomac, United StatesNo longer taking part
- RaleighRaleigh, United StatesNo longer taking part
- Rapid CityRapid City, United StatesTaking people
- RichmondRichmond, United StatesTaking people
- RoseburgRoseburg, United StatesNo longer taking part
- SacramentoSacramento, United StatesTaking people
- SalisburySalisbury, United StatesNo longer taking part
- Salt Lake CitySalt Lake City, United StatesNo longer taking part
- San BernardinoSan Bernardino, United StatesNo longer taking part
- San DiegoSan Diego, United StatesNo longer taking part
- San DimasSan Dimas, United StatesNo longer taking part
- Santa AnaSanta Ana, United StatesNo longer taking part
- SavannahSavannah, United StatesTaking people
- SheffieldSheffield, United StatesNo longer taking part
- ShreveportShreveport, United StatesTaking people
- Sioux CitySioux City, United StatesTaking people
- Sioux FallsSioux Falls, United StatesTaking people
- SouthfieldSouthfield, United StatesTaking people
- SpartanburgSpartanburg, United StatesTaking people
- SpokaneSpokane, United StatesTaking people
- St LouisSt Louis, United StatesTaking people
- St. PetersburgSt. Petersburg, United StatesTaking people
- StatesvilleStatesville, United StatesTaking people
- SuffolkSuffolk, United StatesTaking people
- Sun City CenterSun City Center, United StatesNo longer taking part
- TamaracTamarac, United StatesNo longer taking part
- TampaTampa, United StatesTaking people
- TarzanaTarzana, United StatesTaking people
- TempeTempe, United StatesNo longer taking part
- The BronxThe Bronx, United StatesTaking people
- Thousand OaksThousand Oaks, United StatesTaking people
- ToledoToledo, United StatesNo longer taking part
- Toms RiverToms River, United StatesTaking people
- TuckerTucker, United StatesTaking people
- TucsonTucson, United StatesTaking people
- TullahomaTullahoma, United StatesTaking people
- TulsaTulsa, United StatesTaking people
- UnionUnion, United StatesTaking people
- Union CityUnion City, United StatesNo longer taking part
- ValparaisoValparaiso, United StatesTaking people
- Van NuysVan Nuys, United StatesNo longer taking part
- VestalVestal, United StatesNo longer taking part
- VictoriaVictoria, United StatesNo longer taking part
- VistaVista, United StatesTaking people
- WacoWaco, United StatesTaking people
- Washington D.C.Washington D.C., United StatesNo longer taking part
- West JordanWest Jordan, United StatesNo longer taking part
- West Valley CityWest Valley City, United StatesTaking people
- WestminsterWestminster, United StatesNo longer taking part
- WichitaWichita, United StatesTaking people
- Wichita FallsWichita Falls, United StatesNo longer taking part
- WilmingtonWilmington, United StatesNo longer taking part
- WinfieldWinfield, United StatesTaking people
- Winston-SalemWinston-Salem, United StatesTaking people
- WylieWylie, United StatesTaking people
- ZacharyZachary, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- AstraZeneca
- Trial code
- NCT06283966EU 2023-507407-59-00
- Record updated
- 2 October 2026
- Original description
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.Read full original descriptionShow less
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)
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.
Inclusion: Male or female participants must be 40 to 80 years of age inclusive, at the time of signing; the ICF; Demonstrate acceptable MDI administration technique at Visit 1 (V1) and Visit 2 (V2); A diagnosis of COPD confirmed by a post-bronchodilator FEV1/FVC ratio < 70%; at V1; 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; A baseline peripheral blood eosinophil count of ≥ 100 cells/mm3 assessed at Visit 1 by; the central laboratory; A CAT score of ≥ 10 at Visit 1; Participant must fulfill at least 1 of the 4 CV disease/risk factor criteria below [(a), (b),; (c), or (d)]:; : Established CV Disease; : Combination of CV risk factors:; Hypertension; Diabetes Mellitus; Chronic Kidney Disease; Dyslipidemia; Obesity; : High risk of CV disease determined using an established CV risk assessment; tool; : CT coronary Artery Calcification; Willing and, in the opinion of the investigator, able to adjust current COPD therapy, as; required by the protocol; Willing to visit at the study site or participate in virtual visits as required per the protocol; to complete all study assessments; 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; Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in the protocol.
Exclusion: 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; Implanted left ventricular assist device or implant anticipated in < 3 months; History of lung cancer and/or treatment for lung cancer within the 5 years prior to Visit 1; Pneumonia and/or moderate or severe COPD exacerbation that has not resolved at least 8 weeks prior to Visit 1; Unable to abstain from protocol-defined prohibited medications; 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); Previous randomization in the present study; End-stage renal disease requiring renal replacement therapy; History of heart or lung transplant or actively listed for heart or lung transplant; Unstable or life-threatening cardiac disease - participants with any of the following at Visit 1 would be excluded:; An MI or unstable angina in the last 8 weeks; 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; Participants with a known hypersensitivity to LAMA, LABA or ICS or any component of the MDI; 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; Use of maintenance ICS treatment within the past 12 months; Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site); 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; For females only - currently pregnant (confirmed with positive pregnancy test) or breastfeeding.