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)

Status: Recruiting
Location: See all (903) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 80
Healthy Volunteers: f
View:

• 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.

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Bayonne
Research Site
NOT_YET_RECRUITING
Bayonne
Research Site
WITHDRAWN
Biarritz
Research Site
RECRUITING
Blois
Research Site
RECRUITING
Brest
Research Site
RECRUITING
Brest
Research Site
RECRUITING
Cannes
Research Site
NOT_YET_RECRUITING
Cherbourg
Research Site
RECRUITING
Créteil
Research Site
RECRUITING
La Tronche
Research Site
RECRUITING
Laval
Research Site
RECRUITING
Le Coudray
Research Site
RECRUITING
Lomme
Research Site
RECRUITING
Lyon
Research Site
RECRUITING
Marseille
Research Site
RECRUITING
Marseille
Research Site
RECRUITING
Mulhouse
Research Site
WITHDRAWN
Paris
Research Site
RECRUITING
Paris
Research Site
RECRUITING
Pessac
Research Site
RECRUITING
Pringy
Research Site
RECRUITING
Quint-fonsegrives
Research Site
RECRUITING
Reims
Research Site
RECRUITING
Roscoff
Research Site
RECRUITING
Strasbourg
Research Site
RECRUITING
Vandœuvre-lès-nancy
Research Site
RECRUITING
Vannes
Research Site
RECRUITING
Villeurbanne
Germany
Research Site
RECRUITING
Ahrensburg
Research Site
RECRUITING
Augsburg
Research Site
RECRUITING
Bamberg
Research Site
RECRUITING
Berlin
Research Site
RECRUITING
Berlin
Research Site
RECRUITING
Berlin
Research Site
RECRUITING
Berlin
Research Site
RECRUITING
Berlin
Research Site
RECRUITING
Berlin
Research Site
RECRUITING
Berlin
Research Site
RECRUITING
Berlin
Research Site
RECRUITING
Berlin
Research Site
RECRUITING
Bonn
Research Site
WITHDRAWN
Bremen
Research Site
WITHDRAWN
Bremen
Research Site
RECRUITING
Cottbus
Research Site
TERMINATED
Dachau
Research Site
RECRUITING
Darmstadt
Research Site
WITHDRAWN
Deggingen
Research Site
TERMINATED
Dresden
Research Site
TERMINATED
Essen
Research Site
RECRUITING
Essen
Research Site
RECRUITING
Frankfurt
Research Site
RECRUITING
Hamburg
Research Site
RECRUITING
Hamburg
Research Site
RECRUITING
Hanover
Research Site
RECRUITING
Hanover
Research Site
WITHDRAWN
Heidelberg
Research Site
RECRUITING
Ibbenbueren
Research Site
TERMINATED
Karlsruhe
Research Site
RECRUITING
Landsberg
Research Site
RECRUITING
Leipzig
Research Site
RECRUITING
Leipzig
Research Site
RECRUITING
Leipzig
Research Site
RECRUITING
Lübeck
Research Site
RECRUITING
Mainz
Research Site
RECRUITING
Marburg
Research Site
RECRUITING
Moers
Research Site
RECRUITING
München
Research Site
RECRUITING
Offenbach
Research Site
WITHDRAWN
Offenbach
Research Site
RECRUITING
Peine
Research Site
RECRUITING
Rheine
Research Site
RECRUITING
Riesa
Research Site
RECRUITING
Rosenheim
Research Site
RECRUITING
Solingen
Research Site
RECRUITING
Wallerfing
Research Site
WITHDRAWN
Weißenburg
Research Site
RECRUITING
Wermsdorf
Research Site
RECRUITING
Wiesbaden
Research Site
RECRUITING
Wiesbaden
Research Site
RECRUITING
Witten
Greece
Research Site
RECRUITING
Athens
Research Site
RECRUITING
Athens
Research Site
RECRUITING
Athens
Research Site
WITHDRAWN
Athens
Research Site
RECRUITING
Athens
Research Site
RECRUITING
Athens
Research Site
RECRUITING
Ioannina
Research Site
RECRUITING
Pátrai
Research Site
RECRUITING
Thessaloniki
Research Site
RECRUITING
Thessaloniki
Hungary
Research Site
NOT_YET_RECRUITING
Balatonfüred
Research Site
NOT_YET_RECRUITING
Békéscsaba
Research Site
RECRUITING
Budapest
Research Site
RECRUITING
Budapest
Research Site
WITHDRAWN
Budapest
Research Site
NOT_YET_RECRUITING
Debrecen
Research Site
RECRUITING
Edelény
Research Site
NOT_YET_RECRUITING
Encs
Research Site
WITHDRAWN
Gödöllő
Research Site
RECRUITING
Gyöngyös - Mátraháza
Research Site
RECRUITING
Hajdúnánás
Research Site
RECRUITING
Kalocsa
Research Site
RECRUITING
Komádi
Research Site
WITHDRAWN
Monor
Research Site
WITHDRAWN
Pécs
Research Site
RECRUITING
Püspökladány
Research Site
RECRUITING
Százhalombatta
Research Site
NOT_YET_RECRUITING
Szeged
Research Site
WITHDRAWN
Székesfehérvár
Research Site
RECRUITING
Szolnok
Research Site
RECRUITING
Tapolca
Research Site
RECRUITING
Törökbálint
Research Site
RECRUITING
Vajszló
India
Research Site
RECRUITING
Ahmedabad
Research Site
RECRUITING
Ahmedabad
Research Site
RECRUITING
Aligarh
Research Site
RECRUITING
Belagavi
Research Site
RECRUITING
Calicut
Research Site
WITHDRAWN
Chandigarh
Research Site
RECRUITING
Dehradun
Research Site
RECRUITING
Delhi
Research Site
NOT_YET_RECRUITING
Dwārka
Research Site
RECRUITING
Hyderabad
Research Site
RECRUITING
Hyderabad
Research Site
RECRUITING
Jaipur
Research Site
WITHDRAWN
Kolkata
Research Site
NOT_YET_RECRUITING
Kolkata
Research Site
WITHDRAWN
Mangalore
Research Site
WITHDRAWN
Mumbai
Research Site
RECRUITING
Nagpur
Research Site
NOT_YET_RECRUITING
New Delhi
Research Site
WITHDRAWN
New Delhi
Research Site
RECRUITING
Pune
Research Site
NOT_YET_RECRUITING
Vijayawada
Italy
Research Site
RECRUITING
Ancona
Research Site
RECRUITING
Florence
Research Site
RECRUITING
Genoa
Research Site
RECRUITING
Mestre
Research Site
COMPLETED
Milan
Research Site
RECRUITING
Napoli
Research Site
RECRUITING
Pavia
Research Site
RECRUITING
Perugia
Research Site
RECRUITING
Roma
Research Site
RECRUITING
Roma
Research Site
RECRUITING
Roma
Research Site
RECRUITING
Rome
Research Site
RECRUITING
Siena
Research Site
RECRUITING
Varese
Japan
Research Site
RECRUITING
Chūōku
Research Site
RECRUITING
Fujieda-shi
Research Site
RECRUITING
Fukuoka
Research Site
RECRUITING
Kitakyushu
Research Site
RECRUITING
Kobe
Research Site
RECRUITING
Kure-shi
Research Site
RECRUITING
Kure-shi
Research Site
RECRUITING
Kyoto
Research Site
RECRUITING
Minoh
Research Site
RECRUITING
Mizunami-shi
Research Site
RECRUITING
Okayama
Research Site
RECRUITING
Osaka
Research Site
RECRUITING
Osaka
Research Site
RECRUITING
Osaki-shi
Research Site
RECRUITING
Sendai
Research Site
RECRUITING
Shinjuku-ku
Research Site
RECRUITING
Shinjuku-ku
Research Site
RECRUITING
Takamatsu
Research Site
RECRUITING
Yamagata
Research Site
RECRUITING
Yanagawa-shi
Research Site
RECRUITING
Yokohama
Malaysia
Research Site
RECRUITING
Alor Star
Research Site
RECRUITING
Kajang
Research Site
RECRUITING
Kuala Lumpur
Research Site
RECRUITING
Kuala Pilah
Research Site
RECRUITING
Sandakan
Research Site
RECRUITING
Sarawak Miri
Research Site
WITHDRAWN
Seremban
Research Site
RECRUITING
Sibu
Mexico
Research Site
NOT_YET_RECRUITING
Benito Juárez
Research Site
NOT_YET_RECRUITING
Chihuahua City
Research Site
WITHDRAWN
Cuernavaca
Research Site
RECRUITING
Cuernavaca
Research Site
NOT_YET_RECRUITING
Culiacán
Research Site
RECRUITING
Guadalajara
Research Site
NOT_YET_RECRUITING
Guadalajara
Research Site
NOT_YET_RECRUITING
Juriquilla
Research Site
RECRUITING
Mérida
Research Site
RECRUITING
Metepec
Research Site
NOT_YET_RECRUITING
Mexico City
Research Site
NOT_YET_RECRUITING
Monterrey
Research Site
RECRUITING
Monterrey
Research Site
RECRUITING
Oaxaca City
Research Site
NOT_YET_RECRUITING
Tijuana
Research Site
RECRUITING
Veracruz
Research Site
RECRUITING
Xalapa
Research Site
RECRUITING
Zapopan
Norway
Research Site
RECRUITING
Kongsberg
Research Site
RECRUITING
Lørenskog
Research Site
RECRUITING
Skedsmokorset
Research Site
RECRUITING
Trondheim
Peru
Research Site
WITHDRAWN
El Agustino
Research Site
RECRUITING
Lima
Research Site
NOT_YET_RECRUITING
Lima
Research Site
RECRUITING
Lima
Research Site
RECRUITING
Lima
Research Site
NOT_YET_RECRUITING
Lima
Research Site
RECRUITING
Lima
Research Site
RECRUITING
Lima
Research Site
RECRUITING
Lima
Research Site
RECRUITING
Lima
Research Site
RECRUITING
Lima
Research Site
RECRUITING
Lima
Research Site
NOT_YET_RECRUITING
Lima
Research Site
RECRUITING
Lima
Research Site
RECRUITING
Lima
Research Site
RECRUITING
Piura
Philippines
Research Site
RECRUITING
Dagupan
Research Site
RECRUITING
Iloilo City
Research Site
RECRUITING
Las Piñas
Research Site
WITHDRAWN
Mabalacat
Research Site
WITHDRAWN
Manadaluyong City
Research Site
RECRUITING
Manila
Research Site
WITHDRAWN
Manila
Research Site
RECRUITING
Marilao
Research Site
RECRUITING
Puerto Princesa City
Research Site
RECRUITING
Quezon City
Research Site
RECRUITING
Quezon City
Research Site
RECRUITING
Quezon City
Research Site
RECRUITING
Roxas City
Research Site
RECRUITING
Tondo
Poland
Research Site
NOT_YET_RECRUITING
Bialystok
Research Site
RECRUITING
Bialystok
Research Site
RECRUITING
Bydgoszcz
Research Site
RECRUITING
Chęciny
Research Site
RECRUITING
Chojnice
Research Site
NOT_YET_RECRUITING
Częstochowa
Research Site
RECRUITING
Inowrocław
Research Site
RECRUITING
Karczew
Research Site
RECRUITING
Katowice
Research Site
RECRUITING
Katowice
Research Site
WITHDRAWN
Kielce
Research Site
RECRUITING
Kielce
Research Site
RECRUITING
Krakow
Research Site
RECRUITING
Krakow
Research Site
RECRUITING
Libiąż
Research Site
WITHDRAWN
Lodz
Research Site
RECRUITING
Lodz
Research Site
WITHDRAWN
Lubin
Research Site
RECRUITING
Lublin
Research Site
RECRUITING
Lublin
Research Site
WITHDRAWN
Ostrowiec Świętokrzyski
Research Site
RECRUITING
Piaseczno
Research Site
RECRUITING
Płock
Research Site
SUSPENDED
Poznan
Research Site
RECRUITING
Poznan
Research Site
RECRUITING
Rzeszów
Research Site
SUSPENDED
Sieradz
Research Site
NOT_YET_RECRUITING
Skórzewo
Research Site
WITHDRAWN
Słupsk
Research Site
RECRUITING
Sochaczew
Research Site
RECRUITING
Sosnowiec
Research Site
WITHDRAWN
Sosnowiec
Research Site
RECRUITING
Szczecin
Research Site
RECRUITING
Torun
Research Site
RECRUITING
Ustroń
Research Site
RECRUITING
Warsaw
Research Site
RECRUITING
Warsaw
Research Site
SUSPENDED
Warsaw
Research Site
RECRUITING
Wroclaw
Research Site
RECRUITING
Wroclaw
Republic of Korea
Research Site
RECRUITING
Anyang-si
Research Site
RECRUITING
Busan
Research Site
RECRUITING
Daegu
Research Site
WITHDRAWN
Gwangju
Research Site
RECRUITING
Jeonju
Research Site
RECRUITING
Seoul
Research Site
RECRUITING
Seoul
Research Site
NOT_YET_RECRUITING
Seoul
Research Site
RECRUITING
Seoul
Research Site
RECRUITING
Seoul
Research Site
RECRUITING
Seoul
Research Site
RECRUITING
Uijeongbu-si
Research Site
RECRUITING
Ulsan
Romania
Research Site
RECRUITING
Bucharest
Research Site
RECRUITING
Bucharest
Research Site
RECRUITING
Bucharest
Research Site
RECRUITING
Cluj-napoca
Research Site
RECRUITING
Leamna De Sus
Research Site
RECRUITING
Negreşti-oaş
Research Site
RECRUITING
Oradea
Research Site
RECRUITING
Târgu Mureş
Research Site
RECRUITING
Timișoara
Research Site
RECRUITING
Timișoara
Research Site
RECRUITING
Timișoara
Serbia
Research Site
RECRUITING
Belgrade
Research Site
RECRUITING
Belgrade
Research Site
RECRUITING
Belgrade
Research Site
RECRUITING
Kamenitz
Research Site
RECRUITING
Kragujevac
Research Site
RECRUITING
Niš
Research Site
RECRUITING
Novi Sad
Slovakia
Research Site
RECRUITING
Bratislava
Research Site
RECRUITING
Brezno
Research Site
RECRUITING
Humenné
Research Site
RECRUITING
Košice
Research Site
WITHDRAWN
Kráľovský Chlmec
Research Site
RECRUITING
Levice
Research Site
WITHDRAWN
Prešov
Research Site
RECRUITING
Topoľčany
Spain
Research Site
RECRUITING
Alicante
Research Site
RECRUITING
Badia Del Vallès
Research Site
WITHDRAWN
Barakaldo
Research Site
RECRUITING
Barcelona
Research Site
RECRUITING
Barcelona
Research Site
RECRUITING
Castro Urdiales
Research Site
RECRUITING
Córdoba
Research Site
RECRUITING
Granada
Research Site
RECRUITING
Madrid
Research Site
RECRUITING
Málaga
Research Site
RECRUITING
Marbella (málaga)
Research Site
WITHDRAWN
Mataró
Research Site
RECRUITING
Mataró
Research Site
RECRUITING
Palma
Research Site
RECRUITING
Patraix
Research Site
WITHDRAWN
Santa Cruz De Tenerife
Research Site
RECRUITING
Santiago De Compostela-coruña
Sweden
Research Site
NOT_YET_RECRUITING
Danderyd
Research Site
RECRUITING
Gothenburg
Research Site
WITHDRAWN
Gothenburg
Research Site
RECRUITING
Höllviken
Research Site
RECRUITING
Kungsbacka
Research Site
RECRUITING
Lund
Research Site
RECRUITING
Örebro
Research Site
RECRUITING
Stockholm
Research Site
RECRUITING
Stockholm
Research Site
RECRUITING
Stockholm
Research Site
RECRUITING
Umeå
Research Site
RECRUITING
Uppsala
Taiwan
Research Site
RECRUITING
Changhua County
Research Site
RECRUITING
Kaohsiung City
Research Site
RECRUITING
Kaohsiung City
Research Site
NOT_YET_RECRUITING
Taichung
Research Site
RECRUITING
Taichung
Research Site
RECRUITING
Taichung
Research Site
RECRUITING
Taichung
Research Site
RECRUITING
Tainan City
Research Site
TERMINATED
Taipei
Research Site
RECRUITING
Taipei
Research Site
RECRUITING
Taoyuan
Research Site
RECRUITING
Taoyuan District
Research Site
RECRUITING
Yunlin
Thailand
Research Site
RECRUITING
Bang Kra So
Research Site
RECRUITING
Bangkok
Research Site
RECRUITING
Hat Yai
Research Site
RECRUITING
Khlong Luang
Research Site
RECRUITING
Muang
Research Site
RECRUITING
Muang
Research Site
RECRUITING
Muang
Research Site
RECRUITING
Ongkharak
Research Site
RECRUITING
Phitsanulok
Research Site
RECRUITING
Ratchathewi
Turkey
Research Site
RECRUITING
Adana
Research Site
RECRUITING
Adana
Research Site
RECRUITING
Afyonkarahisar
Research Site
RECRUITING
Antalya
Research Site
RECRUITING
Bursa
Research Site
RECRUITING
Bursa
Research Site
RECRUITING
Çanakkale
Research Site
RECRUITING
Çankaya
Research Site
RECRUITING
Isparta
Research Site
RECRUITING
Istanbul
Research Site
NOT_YET_RECRUITING
Istanbul
Research Site
NOT_YET_RECRUITING
Izmir
Research Site
RECRUITING
Izmir
Research Site
RECRUITING
Kayseri
Research Site
RECRUITING
Kocaeli
Research Site
RECRUITING
Mersin
Research Site
RECRUITING
Tekirdağ
Research Site
RECRUITING
Zeytinburnu
Ukraine
Research Site
RECRUITING
Chernivtsi
Research Site
RECRUITING
Chernivtsі
Research Site
RECRUITING
Ivano-frankivsk
Research Site
RECRUITING
Ivano-frankivsk
Research Site
NOT_YET_RECRUITING
Kyiv
Research Site
RECRUITING
Kyiv
Research Site
RECRUITING
Kyiv
Research Site
RECRUITING
Kyiv
Research Site
NOT_YET_RECRUITING
Lviv
Research Site
RECRUITING
Ternopil
Research Site
RECRUITING
Uzhhorod
Research Site
RECRUITING
Vinnytsia
Research Site
NOT_YET_RECRUITING
Vinnytsia
Research Site
WITHDRAWN
Vinnytsia
Research Site
RECRUITING
Vinnytsia
United Kingdom
Research Site
RECRUITING
Bicester
Research Site
RECRUITING
Bollington
Research Site
RECRUITING
Bradford
Research Site
RECRUITING
Cardiff
Research Site
RECRUITING
Chesterfield
Research Site
RECRUITING
Corby
Research Site
WITHDRAWN
Cottingham
Research Site
RECRUITING
Fowey
Research Site
RECRUITING
Glasgow
Research Site
RECRUITING
Hounslow
Research Site
RECRUITING
Liverpool
Research Site
RECRUITING
London
Research Site
RECRUITING
London
Research Site
RECRUITING
London
Research Site
RECRUITING
Manchester
Research Site
RECRUITING
Newquay
Research Site
RECRUITING
North Somerset
Research Site
RECRUITING
Northallerton
Research Site
WITHDRAWN
Norwich
Research Site
WITHDRAWN
Nottingham
Research Site
WITHDRAWN
Perth
Research Site
RECRUITING
Poole
Research Site
RECRUITING
Sheffield
Research Site
RECRUITING
Torbay
Research Site
RECRUITING
Whitney
Research Site
RECRUITING
Witney
Contact Information
Primary
AstraZeneca Clinical Study Information Center
information.center@astrazeneca.com
1-877-240-9479
Time Frame
Start Date: 2024-02-21
Estimated Completion Date: 2028-03-07
Participants
Target number of participants: 5000
Treatments
Experimental: BGF arm
BGF MDI 320/14.4/9.6 μg BID
Experimental: GFF arm
GFF MDI 14.4/9.6 μg BID
Sponsors
Leads: AstraZeneca

This content was sourced from clinicaltrials.gov