Study to Assess PT010 in Adult and Adolescent Participants With Inadequately Controlled Asthma (LOGOS) (LOGOS)

February 13, 2024 updated by: AstraZeneca

A Randomized, Double-Blind, Double Dummy, Parallel Group, Multicenter Variable Length Study to Assess the Efficacy and Safety of PT010 Relative to PT009 and Symbicort® in Adult and Adolescent Participants With Inadequately Controlled Asthma

This is a variable length study to evaluate the efficacy and safety of budesonide/glycopyrronium/formoterol inhaler in adults and adolescents with severe asthma inadequately controlled with standard of care.

Study Overview

Status

Recruiting

Conditions

Asthma

Intervention / Treatment

Detailed Description

This is a randomized, double-blind, double dummy, parallel group, multicenter 24 to 52 week variable length study to assess the efficacy and safety of budesonide, glycopyrronium, and formoterol fumarate metered dose inhaler (MDI) relative to budesonide and formoterol fumarate MDI and Symbicort® pressurized MDI in adult and adolescent participants with inadequately controlled asthma. Approximately 2200 participants will be randomized globally.

Study Type

Interventional

Enrollment (Estimated)

2200

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: AstraZeneca Clinical Study Information Center
Phone Number: 1-877-240-9479
Email: information.center@astrazeneca.com

Study Locations

Austria
- - Feldbach, Austria, A-8330
    - Withdrawn
    - Research Site
  - Linz, Austria, 4020
    - Withdrawn
    - Research Site
  - Thalheim, Austria, 4600
    - Withdrawn
    - Research Site
Brazil
- - Botucatu, Brazil, 18618-970
    - Recruiting
    - Research Site
  - Porto Alegre, Brazil, 91350-200
    - Recruiting
    - Research Site
  - Porto Alegre, Brazil, 90430-001
    - Recruiting
    - Research Site
  - Porto Alegre, Brazil, 90610-000
    - Recruiting
    - Research Site
  - Porto Alegre, Brazil, 9002-060
    - Recruiting
    - Research Site
  - Santo Andre, Brazil, 09080-110
    - Recruiting
    - Research Site
  - Sorocaba, Brazil, 18040-425
    - Recruiting
    - Research Site
  - São Paulo, Brazil, 05403-000
    - Recruiting
    - Research Site
  - Uberlandia, Brazil, 38411-186
    - Withdrawn
    - Research Site
China
- - Anhui, China, 230061
    - Recruiting
    - Research Site
  - Baotou, China, 014010
    - Recruiting
    - Research Site
  - Beijing, China, 100020
    - Recruiting
    - Research Site
  - Beijing, China, 102218
    - Not yet recruiting
    - Research Site
  - Beijing, China
    - Withdrawn
    - Research Site
  - Changchun, China
    - Recruiting
    - Research Site
  - Changsha, China, 410005
    - Recruiting
    - Research Site
  - Changsha, China, 410008
    - Recruiting
    - Research Site
  - Changsha, China, 430033
    - Recruiting
    - Research Site
  - Changzhi, China, 46000
    - Recruiting
    - Research Site
  - Chengdu, China, 610072
    - Recruiting
    - Research Site
  - Chengdu, China, 610041
    - Withdrawn
    - Research Site
  - Chengdu, China, 611130
    - Recruiting
    - Research Site
  - Chizhou, China, 247099
    - Not yet recruiting
    - Research Site
  - Chongqing, China, 400010
    - Recruiting
    - Research Site
  - Chongqing, China, 400038
    - Recruiting
    - Research Site
  - Dongyang, China, 322100
    - Recruiting
    - Research Site
  - Fuzhou, China, 350025
    - Recruiting
    - Research Site
  - Gongguan, China
    - Recruiting
    - Research Site
  - Guangzhou, China, 510120
    - Recruiting
    - Research Site
  - Guangzhou, China, 510280
    - Recruiting
    - Research Site
  - Guangzhou, China
    - Recruiting
    - Research Site
  - Guangzhou, China, 510062
    - Recruiting
    - Research Site
  - Guangzhou, China, 510180
    - Recruiting
    - Research Site
  - Guangzhou, China, 510630
    - Recruiting
    - Research Site
  - Guiyang, China, 550002
    - Withdrawn
    - Research Site
  - Haikou, China, 570311
    - Recruiting
    - Research Site
  - Haikou, China, 570208
    - Recruiting
    - Research Site
  - Hangzhou, China, 310006
    - Withdrawn
    - Research Site
  - Hangzhou, China, 310009
    - Recruiting
    - Research Site
  - Hangzhou, China, 310005
    - Recruiting
    - Research Site
  - Hefei, China, 230022
    - Withdrawn
    - Research Site
  - Hefei, China, 230000
    - Terminated
    - Research Site
  - Hefei, China, 230011
    - Not yet recruiting
    - Research Site
  - Hohhot, China, 010017
    - Withdrawn
    - Research Site
  - Huai'an, China, 223300
    - Recruiting
    - Research Site
  - Huizhou, China, 516001
    - Recruiting
    - Research Site
  - Jinan, China, 250001
    - Withdrawn
    - Research Site
  - Jinan, China, 250021
    - Withdrawn
    - Research Site
  - Jinan, China, 250117
    - Recruiting
    - Research Site
  - Jinhua, China, 321000
    - Recruiting
    - Research Site
  - Kunming, China, 650032
    - Recruiting
    - Research Site
  - Kunming, China, 650051
    - Recruiting
    - Research Site
  - Lanzhou, China, 730000
    - Recruiting
    - Research Site
  - Liuzhou, China, 545006
    - Not yet recruiting
    - Research Site
  - Luoyang, China, 471003
    - Recruiting
    - Research Site
  - Nan Chong, China, 637000
    - Recruiting
    - Research Site
  - Nanchang, China, 330006
    - Recruiting
    - Research Site
  - Nanjing, China, 210009
    - Recruiting
    - Research Site
  - Nanjing, China, 210029
    - Recruiting
    - Research Site
  - Nanjing, China, 210008
    - Recruiting
    - Research Site
  - Nanjing, China, 210006
    - Recruiting
    - Research Site
  - Nanning, China, 530021
    - Recruiting
    - Research Site
  - Qingdao, China, 266000
    - Recruiting
    - Research Site
  - Shanghai, China, 200025
    - Recruiting
    - Research Site
  - Shanghai, China, 200032
    - Recruiting
    - Research Site
  - Shanghai, China, 200233
    - Withdrawn
    - Research Site
  - Shanghai, China, 201199
    - Recruiting
    - Research Site
  - Shanghai, China, 200080
    - Recruiting
    - Research Site
  - Shanghai, China, 2000127
    - Recruiting
    - Research Site
  - Shanghai, China, 200065
    - Recruiting
    - Research Site
  - Shanghai, China, 200240
    - Recruiting
    - Research Site
  - Shanghai, China, 200092
    - Recruiting
    - Research Site
  - Shanghai, China, 200433
    - Withdrawn
    - Research Site
  - Shangrao, China, 334000
    - Withdrawn
    - Research Site
  - Shantou, China, 515041
    - Recruiting
    - Research Site
  - Shaoxing, China, 312000
    - Recruiting
    - Research Site
  - Shengyang, China, 110004
    - Recruiting
    - Research Site
  - Shenyang, China, 110015
    - Recruiting
    - Research Site
  - Shenyang, China, 110001
    - Recruiting
    - Research Site
  - Shenzhen, China, 518036
    - Recruiting
    - Research Site
  - Shenzhen, China, 518020
    - Recruiting
    - Research Site
  - Shenzhen, China, 518039
    - Recruiting
    - Research Site
  - Shihezi, China, 830000
    - Withdrawn
    - Research Site
  - Shijiazhuang, China, 50051
    - Recruiting
    - Research Site
  - Tai'an, China, 271000
    - Withdrawn
    - Research Site
  - Taiyuan, China, 030001
    - Recruiting
    - Research Site
  - Taiyuan, China, 030032
    - Not yet recruiting
    - Research Site
  - Taizhou, China, 318020
    - Recruiting
    - Research Site
  - Urumqi, China, 830054
    - Recruiting
    - Research Site
  - Wenzhou, China, 325027
    - Not yet recruiting
    - Research Site
  - Wuhan, China, 430010
    - Recruiting
    - Research Site
  - Wuhan, China, 430030
    - Terminated
    - Research Site
  - Wuhu, China, 241000
    - Recruiting
    - Research Site
  - XI 'an, China, 710077
    - Not yet recruiting
    - Research Site
  - Xi'an, China, 710004
    - Recruiting
    - Research Site
  - Xian, China, 710061
    - Withdrawn
    - Research Site
  - Xinxiang, China, 453002
    - Recruiting
    - Research Site
  - Xuzhou, China, 221000
    - Recruiting
    - Research Site
  - Xuzhou, China, 221009
    - Recruiting
    - Research Site
  - Xuzhou, China
    - Withdrawn
    - Research Site
  - Yangzhou, China, 225001
    - Recruiting
    - Research Site
  - Yinchuan, China, 750004
    - Recruiting
    - Research Site
  - Yinchuan, China, 750001
    - Recruiting
    - Research Site
  - Yueyang, China, 414000
    - Not yet recruiting
    - Research Site
  - Zhangzhou, China, 363099
    - Not yet recruiting
    - Research Site
  - Zhanjiang, China, 524001
    - Recruiting
    - Research Site
  - Zhengzhou, China, 450000
    - Recruiting
    - Research Site
  - Zhengzhou City, China, 450000
    - Recruiting
    - Research Site
  - Zhuji, China
    - Recruiting
    - Research Site
Colombia
- - Barranquilla, Colombia, 080020
    - Not yet recruiting
    - Research Site
  - Bogota, Colombia, 110221
    - Not yet recruiting
    - Research Site
  - Cartagena, Colombia, 130013
    - Not yet recruiting
    - Research Site
  - Manizales, Colombia, 17001
    - Withdrawn
    - Research Site
  - Medellin, Colombia, 050034
    - Not yet recruiting
    - Research Site
  - Medellin, Colombia, 050621
    - Not yet recruiting
    - Research Site
  - Rionegro, Colombia, 054047
    - Not yet recruiting
    - Research Site
  - San Gil, Colombia, 684031
    - Withdrawn
    - Research Site
Costa Rica
- - San José, Costa Rica, 10103
    - Withdrawn
    - Research Site
  - Santa Ana, Costa Rica, 10903
    - Withdrawn
    - Research Site
Czechia
- - Brandys nad Labem, Czechia, 250 01
    - Recruiting
    - Research Site
  - Jindrichuv Hradec, Czechia, 377 01
    - Recruiting
    - Research Site
  - Liberec, Czechia, 460 01
    - Withdrawn
    - Research Site
  - Lovosice, Czechia, 410 02
    - Recruiting
    - Research Site
  - Mlada Boleslav, Czechia, 293 01
    - Recruiting
    - Research Site
  - Novy Bor, Czechia, 473 01
    - Recruiting
    - Research Site
  - Praha 11, Czechia, 148 00
    - Recruiting
    - Research Site
  - Praha 9, Czechia, 190 00
    - Recruiting
    - Research Site
  - Rokycany, Czechia, 337 22
    - Recruiting
    - Research Site
  - Strakonice, Czechia, 38601
    - Recruiting
    - Research Site
  - Teplice, Czechia, 415 01
    - Recruiting
    - Research Site
  - Varnsdorf, Czechia, 407 47
    - Recruiting
    - Research Site
Germany
- - Bamberg, Germany, 96049
    - Recruiting
    - Research Site
  - Berlin, Germany, 10717
    - Recruiting
    - Research Site
  - Berlin, Germany, 13187
    - Recruiting
    - Research Site
  - Berlin, Germany, 10119
    - Recruiting
    - Research Site
  - Berlin, Germany, 10367
    - Recruiting
    - Research Site
  - Berlin, Germany, 12159
    - Recruiting
    - Research Site
  - Berlin, Germany, 13057
    - Withdrawn
    - Research Site
  - Berlin, Germany, 10787
    - Recruiting
    - Research Site
  - Berlin, Germany, 13187
    - Withdrawn
    - Research Site
  - Berlin, Germany, 10787
    - Not yet recruiting
    - Research Site
  - Berlin, Germany, 12203
    - Terminated
    - Research Site
  - Darmstadt, Germany, 64283
    - Recruiting
    - Research Site
  - Duisburg, Germany, 47057
    - Withdrawn
    - Research Site
  - Frankfurt, Germany, 60596
    - Recruiting
    - Research Site
  - Frankfurt am Main, Germany, 60596
    - Recruiting
    - Research Site
  - Frankfurt/Main, Germany, 60389
    - Recruiting
    - Research Site
  - Fürstenwalde/Spree, Germany, 15517
    - Not yet recruiting
    - Research Site
  - Geesthacht, Germany, 21502
    - Recruiting
    - Research Site
  - Hannover, Germany, 30449
    - Recruiting
    - Research Site
  - Hannover, Germany, D-30173
    - Completed
    - Research Site
  - Heidelberg, Germany, 69115
    - Recruiting
    - Research Site
  - Koblenz, Germany, 56068
    - Recruiting
    - Research Site
  - Landsberg, Germany, 86899
    - Recruiting
    - Research Site
  - Leipzig, Germany, 04103
    - Recruiting
    - Research Site
  - Leipzig, Germany, 04207
    - Recruiting
    - Research Site
  - Leipzig, Germany, 04299
    - Recruiting
    - Research Site
  - Leipzig, Germany, 04357
    - Withdrawn
    - Research Site
  - Mainz, Germany, 55128
    - Recruiting
    - Research Site
  - München-Pasing, Germany, 81241
    - Terminated
    - Research Site
  - Rodgau-Dudenhofen, Germany, 63110
    - Withdrawn
    - Research Site
  - Witten, Germany, 58452
    - Recruiting
    - Research Site
Greece
- - Alexandroupolis, Greece, 68100
    - Recruiting
    - Research Site
  - Athens, Greece, 12462
    - Recruiting
    - Research Site
  - Athens, Greece, 11527
    - Recruiting
    - Research Site
  - Athens, Greece, 11527
    - Withdrawn
    - Research Site
  - Athens, Greece, 17562
    - Recruiting
    - Research Site
  - Athens, Greece, 11525
    - Withdrawn
    - Research Site
  - Athens, Greece, 11521
    - Recruiting
    - Research Site
  - Corfu, Greece, 49100
    - Recruiting
    - Research Site
  - Exohi Thessaloniki, Greece, 57010
    - Recruiting
    - Research Site
  - Heraklion, Greece, 71110
    - Withdrawn
    - Research Site
  - Ioannina, Greece, 45500
    - Recruiting
    - Research Site
  - Patras, Greece, 26500
    - Recruiting
    - Research Site
  - Thessaloniki, Greece, 56429
    - Recruiting
    - Research Site
  - Thessaloniki, Greece, 57010
    - Recruiting
    - Research Site
  - Thessaloniki, Greece, 54642
    - Not yet recruiting
    - Research Site
  - Thessaloniki, Greece, 56429
    - Terminated
    - Research Site
Israel
- - Ashqelon, Israel, 7830604
    - Recruiting
    - Research Site
  - Beer Sheva, Israel, 84101
    - Recruiting
    - Research Site
  - Haifa, Israel, 31096
    - Recruiting
    - Research Site
  - Haifa, Israel, 34362
    - Recruiting
    - Research Site
  - Holon, Israel, 5837738
    - Terminated
    - Research Site
  - Jerusalem, Israel, 9103102
    - Recruiting
    - Research Site
  - Jerusalem, Israel, 9112001
    - Recruiting
    - Research Site
  - Kfar Saba, Israel, 4428164
    - Recruiting
    - Research Site
  - Petach-Tikva, Israel, 4920235
    - Withdrawn
    - Research Site
  - Petah Tikva, Israel, 4920235
    - Recruiting
    - Research Site
  - Ramat-Gan, Israel, 52621
    - Withdrawn
    - Research Site
  - Rehovot, Israel, 76100
    - Recruiting
    - Research Site
  - Tel Aviv, Israel, 6423906
    - Recruiting
    - Research Site
Mexico
- - Ciudad de Mexico, Mexico, 6700
    - Withdrawn
    - Research Site
  - Cuernavaca, Mexico, 62290
    - Recruiting
    - Research Site
  - Culiacán, Mexico, 80200
    - Recruiting
    - Research Site
  - Durango, Mexico, 43080
    - Recruiting
    - Research Site
  - Guadalajara, Mexico, 44200
    - Recruiting
    - Research Site
  - Mazatlán, Mexico, 82000
    - Recruiting
    - Research Site
  - Merida, Mexico, 97070
    - Not yet recruiting
    - Research Site
  - Monterrey, Mexico, 64620
    - Recruiting
    - Research Site
  - Monterrey, Mexico, 64710
    - Recruiting
    - Research Site
  - Monterrey, Mexico, 64460
    - Not yet recruiting
    - Research Site
  - Monterrey, Mexico, 64718
    - Recruiting
    - Research Site
  - Puebla, Mexico, 72190
    - Withdrawn
    - Research Site
  - San Luis Potosí, Mexico, 78250
    - Not yet recruiting
    - Research Site
  - Veracruz, Mexico, 91910
    - Recruiting
    - Research Site
  - Villahermosa, Mexico, 86035
    - Recruiting
    - Research Site
  - Zapopan, Mexico, 45138
    - Not yet recruiting
    - Research Site
Portugal
- - Amadora, Portugal, 2720-276
    - Recruiting
    - Research Site
  - Barcelos, Portugal, 4750-333
    - Withdrawn
    - Research Site
  - Braga, Portugal, 4710
    - Recruiting
    - Research Site
  - Coimbra, Portugal, 3040-316
    - Not yet recruiting
    - Research Site
  - Figueira da Foz, Portugal, 3094-001
    - Recruiting
    - Research Site
  - Guarda, Portugal, 6300-035
    - Withdrawn
    - Research Site
  - Guimaraes, Portugal, 4835-044
    - Recruiting
    - Research Site
  - Lisboa, Portugal, 1998-018
    - Recruiting
    - Research Site
  - Lisboa, Portugal, 1649-035
    - Recruiting
    - Research Site
  - Matosinhos, Portugal, 4454-509
    - Recruiting
    - Research Site
  - Vila Nova de Gaia, Portugal, 4434-502
    - Withdrawn
    - Research Site
Puerto Rico
- - Ponce, Puerto Rico, 00717
    - Terminated
    - Research Site
  - Ponce, Puerto Rico, 00780
    - Terminated
    - Research Site
Russian Federation
- - Chelyabinsk, Russian Federation, 454106
    - Completed
    - Research Site
  - Izhevsk, Russian Federation, 426035
    - Recruiting
    - Research Site
  - Kazan, Russian Federation, 420008
    - Recruiting
    - Research Site
  - Kemerovo, Russian Federation, 650002
    - Completed
    - Research Site
  - Kirov, Russian Federation, 610014
    - Withdrawn
    - Research Site
  - Moscow, Russian Federation, 115522
    - Suspended
    - Research Site
  - Moscow, Russian Federation, 125284
    - Terminated
    - Research Site
  - Omsk, Russian Federation, 644050
    - Completed
    - Research Site
  - Penza, Russian Federation, 440067
    - Recruiting
    - Research Site
  - Perm, Russian Federation, 614000
    - Completed
    - Research Site
  - Saint Petersburg, Russian Federation, 194354
    - Completed
    - Research Site
  - Saint Petersburg, Russian Federation, 195257
    - Completed
    - Research Site
  - Saratov, Russian Federation, 410028
    - Suspended
    - Research Site
  - Saratov, Russian Federation, 410053
    - Suspended
    - Research Site
  - Saratov, Russian Federation, 410053
    - Withdrawn
    - Research Site
  - Tomsk, Russian Federation, 634050
    - Suspended
    - Research Site
  - Ulyanovsk, Russian Federation, 432009
    - Recruiting
    - Research Site
Saudi Arabia
- - Ar Riyāḑ, Saudi Arabia, 11426
    - Withdrawn
    - Research Site
  - Jeddah, Saudi Arabia, 21423
    - Withdrawn
    - Research Site
  - Jeddah, Saudi Arabia, 22252
    - Withdrawn
    - Research Site
  - Makkah, Saudi Arabia, 24246
    - Withdrawn
    - Research Site
  - Riyadh, Saudi Arabia, 1121
    - Withdrawn
    - Research Site
  - Riyadh, Saudi Arabia, 12231
    - Withdrawn
    - Research Site
  - Riyadh, Saudi Arabia, 12233
    - Withdrawn
    - Research Site
  - Riyadh, Saudi Arabia, 12713
    - Withdrawn
    - Research Site
Slovakia
- - Bardejov, Slovakia, 085 01
    - Not yet recruiting
    - Research Site
  - Bojnice, Slovakia, 972 01
    - Recruiting
    - Research Site
  - Kezmarok, Slovakia, 060 01
    - Recruiting
    - Research Site
  - Kosice, Slovakia, 04022
    - Recruiting
    - Research Site
  - Levice, Slovakia, 934 01
    - Recruiting
    - Research Site
  - Nove Zamky, Slovakia, 940 01
    - Withdrawn
    - Research Site
  - Nove Zamky, Slovakia, 94001
    - Recruiting
    - Research Site
  - Poprad, Slovakia, 058 01
    - Recruiting
    - Research Site
  - Presov, Slovakia, 081 81
    - Recruiting
    - Research Site
  - Ruzomberok, Slovakia, 034 26
    - Recruiting
    - Research Site
  - Surany, Slovakia, 94201
    - Recruiting
    - Research Site
  - Topolcany, Slovakia, 95501
    - Recruiting
    - Research Site
  - Zilina, Slovakia, 010 01
    - Recruiting
    - Research Site
South Africa
- - Bloemfontein, South Africa, 9301
    - Terminated
    - Research Site
  - Cape Town, South Africa, 7700
    - Recruiting
    - Research Site
  - Cape Town, South Africa, 7570
    - Withdrawn
    - Research Site
  - Cape Town, South Africa, 7764
    - Recruiting
    - Research Site
  - Durban, South Africa, 4001
    - Recruiting
    - Research Site
  - Durban, South Africa, 4091
    - Recruiting
    - Research Site
  - Durban, South Africa, 4093
    - Recruiting
    - Research Site
  - Durban, South Africa, 4450
    - Recruiting
    - Research Site
  - Johannesburg, South Africa, 2001
    - Recruiting
    - Research Site
  - Johannesburg, South Africa, 2013
    - Withdrawn
    - Research Site
  - Lenasia, South Africa, 1821
    - Recruiting
    - Research Site
  - Lenasia Ext8, South Africa, 1820
    - Completed
    - Research Site
  - Panorama, South Africa, 7500
    - Recruiting
    - Research Site
  - Pretoria, South Africa, 0186
    - Recruiting
    - Research Site
  - Tygervalley, South Africa, 7530
    - Recruiting
    - Research Site
  - Umkomaas, South Africa, 4170
    - Recruiting
    - Research Site
Sweden
- - Lund, Sweden, 222 22
    - Withdrawn
    - Research Site
  - Stockholm, Sweden, 111 20
    - Withdrawn
    - Research Site
  - Uppsala, Sweden, 75237
    - Withdrawn
    - Research Site
Turkey
- - Adana, Turkey, 1260
    - Recruiting
    - Research Site
  - Ankara, Turkey, 06280
    - Withdrawn
    - Research Site
  - Ankara, Turkey, 06
    - Recruiting
    - Research Site
  - Bursa, Turkey, 16059
    - Recruiting
    - Research Site
  - Istanbul, Turkey, 34098
    - Recruiting
    - Research Site
  - Istanbul, Turkey, 34010
    - Withdrawn
    - Research Site
  - Izmir, Turkey, 35110
    - Recruiting
    - Research Site
  - Manisa, Turkey, 45030
    - Withdrawn
    - Research Site
  - Mersin, Turkey, 33343
    - Recruiting
    - Research Site
  - Pamukkale, Turkey, 20070
    - Recruiting
    - Research Site
  - İstanbul, Turkey, 34844
    - Recruiting
    - Research Site
United Kingdom
- - Blackpool, United Kingdom, FY3 7EN
    - Terminated
    - Research Site
  - Bradford, United Kingdom, BD9 6RJ
    - Recruiting
    - Research Site
  - Corby, United Kingdom, NN17 2UR
    - Terminated
    - Research Site
  - Hull, United Kingdom, HU16 5JQ
    - Completed
    - Research Site
  - Leicester, United Kingdom, LE5 4LJ
    - Terminated
    - Research Site
  - Rhyl, United Kingdom, LL18 1DA
    - Terminated
    - Research Site
United States
- Alabama
  - Muscle Shoals, Alabama, United States, 35661
    - Withdrawn
    - Research Site
- Arizona
  - Chandler, Arizona, United States, 85224
    - Withdrawn
    - Research Site
  - Chandler, Arizona, United States, 85224
    - Recruiting
    - Research Site
  - Gilbert, Arizona, United States, 85296
    - Withdrawn
    - Research Site
  - Phoenix, Arizona, United States, 85051
    - Recruiting
    - Research Site
  - Tucson, Arizona, United States, 85704
    - Withdrawn
    - Research Site
  - Tucson, Arizona, United States, 85741
    - Terminated
    - Research Site
- Arkansas
  - Conway, Arkansas, United States, 72032
    - Withdrawn
    - Research Site
  - Hot Springs National Park, Arkansas, United States, 71913
    - Recruiting
    - Research Site
  - Little Rock, Arkansas, United States, 72205
    - Withdrawn
    - Research Site
  - Little Rock, Arkansas, United States, 72212
    - Withdrawn
    - Research Site
  - North Little Rock, Arkansas, United States, 72117
    - Withdrawn
    - Research Site
- California
  - Anaheim, California, United States, 92805
    - Withdrawn
    - Research Site
  - Bakersfield, California, United States, 93301
    - Recruiting
    - Research Site
  - Carlsbad, California, United States, 92009
    - Recruiting
    - Research Site
  - Escondido, California, United States, 92025
    - Withdrawn
    - Research Site
  - Huntington Beach, California, United States, 92647
    - Withdrawn
    - Research Site
  - Huntington Beach, California, United States, 92647
    - Recruiting
    - Research Site
  - Inglewood, California, United States, 90303
    - Withdrawn
    - Research Site
  - Lancaster, California, United States, 93534
    - Recruiting
    - Research Site
  - Long Beach, California, United States, 90806
    - Withdrawn
    - Research Site
  - Long Beach, California, United States, 90815
    - Recruiting
    - Research Site
  - Los Angeles, California, United States, 90048
    - Withdrawn
    - Research Site
  - Los Angeles, California, United States, 90033
    - Withdrawn
    - Research Site
  - Mission Viejo, California, United States, 92691
    - Recruiting
    - Research Site
  - North Hollywood, California, United States, 91606
    - Recruiting
    - Research Site
  - Northridge, California, United States, 91324
    - Recruiting
    - Research Site
  - Orange, California, United States, 92868
    - Withdrawn
    - Research Site
  - Palmdale, California, United States, 93550
    - Withdrawn
    - Research Site
  - Rancho Cucamonga, California, United States, 91730
    - Recruiting
    - Research Site
  - Sacramento, California, United States, 95825
    - Withdrawn
    - Research Site
  - Sacramento, California, United States, 95823
    - Recruiting
    - Research Site
  - San Diego, California, United States, 92103
    - Withdrawn
    - Research Site
  - San Diego, California, United States, 92120
    - Withdrawn
    - Research Site
  - San Diego, California, United States, 92123
    - Recruiting
    - Research Site
  - San Jose, California, United States, 95117
    - Terminated
    - Research Site
  - Ventura, California, United States, 93003
    - Recruiting
    - Research Site
  - Walnut Creek, California, United States, 94598
    - Recruiting
    - Research Site
- Colorado
  - Colorado Springs, Colorado, United States, 80907
    - Recruiting
    - Research Site
  - Colorado Springs, Colorado, United States, 80910
    - Terminated
    - Research Site
  - Wheat Ridge, Colorado, United States, 80033
    - Recruiting
    - Research Site
- Delaware
  - Newark, Delaware, United States, 19713
    - Terminated
    - Research Site
- Florida
  - Boca Raton, Florida, United States, 33487
    - Terminated
    - Research Site
  - Clearwater, Florida, United States, 33765
    - Recruiting
    - Research Site
  - Clearwater, Florida, United States, 33756
    - Terminated
    - Research Site
  - Cutler Bay, Florida, United States, 33189
    - Recruiting
    - Research Site
  - Davenport, Florida, United States, 33896
    - Withdrawn
    - Research Site
  - DeBary, Florida, United States, 32713
    - Recruiting
    - Research Site
  - Hialeah, Florida, United States, 33016
    - Recruiting
    - Research Site
  - Kissimmee, Florida, United States, 34746
    - Withdrawn
    - Research Site
  - Lakeland, Florida, United States, 33813
    - Recruiting
    - Research Site
  - Miami, Florida, United States, 33135
    - Recruiting
    - Research Site
  - North Port, Florida, United States, 34287
    - Withdrawn
    - Research Site
  - Orlando, Florida, United States, 32807
    - Withdrawn
    - Research Site
  - Saint Petersburg, Florida, United States, 33704
    - Withdrawn
    - Research Site
  - Tampa, Florida, United States, 33615
    - Terminated
    - Research Site
- Georgia
  - Acworth, Georgia, United States, 30101
    - Terminated
    - Research Site
  - Alpharetta, Georgia, United States, 30022
    - Recruiting
    - Research Site
  - Atlanta, Georgia, United States, 30322
    - Recruiting
    - Research Site
  - Atlanta, Georgia, United States, 30342
    - Recruiting
    - Research Site
  - Atlanta, Georgia, United States, 30342
    - Withdrawn
    - Research Site
  - Buford, Georgia, United States, 30518
    - Withdrawn
    - Research Site
  - Fayetteville, Georgia, United States, 30214
    - Withdrawn
    - Research Site
  - Hinesville, Georgia, United States, 31313
    - Withdrawn
    - Research Site
  - Newnan, Georgia, United States, 30265
    - Withdrawn
    - Research Site
  - Peachtree City, Georgia, United States, 30269
    - Withdrawn
    - Research Site
  - Snellville, Georgia, United States, 30078
    - Recruiting
    - Research Site
  - Stone Mountain, Georgia, United States, 30083
    - Withdrawn
    - Research Site
- Idaho
  - Boise, Idaho, United States, 83706
    - Recruiting
    - Research Site
- Illinois
  - Chicago, Illinois, United States, 60641
    - Withdrawn
    - Research Site
  - Chicago, Illinois, United States, 60621
    - Terminated
    - Research Site
  - Normal, Illinois, United States, 61761
    - Recruiting
    - Research Site
  - Peoria, Illinois, United States, 61636
    - Recruiting
    - Research Site
- Indiana
  - Evansville, Indiana, United States, 47715
    - Terminated
    - Research Site
- Louisiana
  - Marrero, Louisiana, United States, 70072
    - Terminated
    - Research Site
  - Zachary, Louisiana, United States, 70791
    - Recruiting
    - Research Site
- Maryland
  - Baltimore, Maryland, United States, 21224
    - Recruiting
    - Research Site
  - White Marsh, Maryland, United States, 21162
    - Recruiting
    - Research Site
- Massachusetts
  - Fall River, Massachusetts, United States, 02723
    - Recruiting
    - Research Site
  - North Dartmouth, Massachusetts, United States, 02747
    - Withdrawn
    - Research Site
- Michigan
  - Caro, Michigan, United States, 48723
    - Withdrawn
    - Research Site
  - Farmington Hills, Michigan, United States, 48336
    - Recruiting
    - Research Site
  - Rochester, Michigan, United States, 48307
    - Completed
    - Research Site
  - Troy, Michigan, United States, 48085
    - Terminated
    - Research Site
- Missouri
  - Chesterfield, Missouri, United States, 63017
    - Withdrawn
    - Research Site
  - Saint Louis, Missouri, United States, 63141
    - Withdrawn
    - Research Site
  - Saint Louis, Missouri, United States, 63141
    - Recruiting
    - Research Site
  - Warrensburg, Missouri, United States, 64093
    - Terminated
    - Research Site
- Nevada
  - North Las Vegas, Nevada, United States, 89030
    - Recruiting
    - Research Site
- New Hampshire
  - Portsmouth, New Hampshire, United States, 03801
    - Recruiting
    - Research Site
- New Jersey
  - Brick, New Jersey, United States, 08724
    - Withdrawn
    - Research Site
  - Guttenberg, New Jersey, United States, 07093
    - Withdrawn
    - Research Site
  - Ocean City, New Jersey, United States, 07712
    - Recruiting
    - Research Site
- New Mexico
  - Albuquerque, New Mexico, United States, 87102
    - Recruiting
    - Research Site
- New York
  - Bronx, New York, United States, 10459
    - Recruiting
    - Research Site
  - Bronx, New York, United States, 10461
    - Suspended
    - Research Site
  - Bronx, New York, United States, 10467
    - Suspended
    - Research Site
  - Brooklyn, New York, United States, 11236
    - Recruiting
    - Research Site
  - Corning, New York, United States, 14830
    - Withdrawn
    - Research Site
  - North Massapequa, New York, United States, 11758
    - Withdrawn
    - Research Site
  - Port Jefferson, New York, United States, 11766
    - Withdrawn
    - Research Site
  - Rochester, New York, United States, 14642
    - Withdrawn
    - Research Site
- North Carolina
  - Charlotte, North Carolina, United States, 28210
    - Withdrawn
    - Research Site
  - Charlotte, North Carolina, United States, 28226
    - Withdrawn
    - Research Site
  - Elizabeth City, North Carolina, United States, 27909
    - Withdrawn
    - Research Site
  - Greensboro, North Carolina, United States, 27408
    - Terminated
    - Research Site
  - High Point, North Carolina, United States, 27262
    - Withdrawn
    - Research Site
  - Huntersville, North Carolina, United States, 28078
    - Terminated
    - Research Site
  - Monroe, North Carolina, United States, 28112
    - Recruiting
    - Research Site
- Ohio
  - Columbus, Ohio, United States, 43215
    - Recruiting
    - Research Site
- Oklahoma
  - Oklahoma City, Oklahoma, United States, 73106
    - Withdrawn
    - Research Site
- Oregon
  - Portland, Oregon, United States, 97202
    - Recruiting
    - Research Site
- Pennsylvania
  - Jenkintown, Pennsylvania, United States, 19046
    - Terminated
    - Research Site
  - Philadelphia, Pennsylvania, United States, 19140
    - Withdrawn
    - Research Site
  - Philadelphia, Pennsylvania, United States, 19107
    - Terminated
    - Research Site
  - Pittsburgh, Pennsylvania, United States, 15212
    - Withdrawn
    - Research Site
- Rhode Island
  - Johnston, Rhode Island, United States, 02919
    - Withdrawn
    - Research Site
- South Carolina
  - Rock Hill, South Carolina, United States, 29732
    - Withdrawn
    - Research Site
  - Spartanburg, South Carolina, United States, 29303
    - Terminated
    - Research Site
- Tennessee
  - Hendersonville, Tennessee, United States, 37075
    - Withdrawn
    - Research Site
  - Knoxville, Tennessee, United States, 37909
    - Recruiting
    - Research Site
- Texas
  - Amarillo, Texas, United States, 79106
    - Recruiting
    - Research Site
  - Cedar Park, Texas, United States, 78613
    - Terminated
    - Research Site
  - Conroe, Texas, United States, 77384
    - Withdrawn
    - Research Site
  - Corsicana, Texas, United States, 75110
    - Withdrawn
    - Research Site
  - Dallas, Texas, United States, 75230
    - Withdrawn
    - Research Site
  - Dallas, Texas, United States, 75231
    - Withdrawn
    - Research Site
  - Denison, Texas, United States, 75020
    - Recruiting
    - Research Site
  - Denison, Texas, United States, 75020
    - Withdrawn
    - Research Site
  - Forney, Texas, United States, 75126
    - Not yet recruiting
    - Research Site
  - Houston, Texas, United States, 77074
    - Recruiting
    - Research Site
  - Houston, Texas, United States, 77004
    - Withdrawn
    - Research Site
  - Lewisville, Texas, United States, 75067
    - Terminated
    - Research Site
  - McAllen, Texas, United States, 78504
    - Withdrawn
    - Research Site
  - McKinney, Texas, United States, 75069
    - Recruiting
    - Research Site
  - McKinney, Texas, United States, 75071
    - Withdrawn
    - Research Site
  - McKinney, Texas, United States, 75071
    - Recruiting
    - Research Site
  - Mesquite, Texas, United States, 75149
    - Withdrawn
    - Research Site
  - North Richland Hills, Texas, United States, 76180
    - Terminated
    - Research Site
  - Pearland, Texas, United States, 77584
    - Terminated
    - Research Site
  - Pflugerville, Texas, United States, 78660
    - Withdrawn
    - Research Site
  - Pharr, Texas, United States, 78577
    - Withdrawn
    - Research Site
  - Plano, Texas, United States, 75093
    - Terminated
    - Research Site
  - San Antonio, Texas, United States, 78229
    - Withdrawn
    - Research Site
  - San Antonio, Texas, United States, 78258
    - Recruiting
    - Research Site
  - Sugar Land, Texas, United States, 77478
    - Recruiting
    - Research Site
  - Sugar Land, Texas, United States, 77479
    - Terminated
    - Research Site
  - Victoria, Texas, United States, 77901
    - Recruiting
    - Research Site
- Virginia
  - Abingdon, Virginia, United States, 24210
    - Terminated
    - Research Site
  - Burke, Virginia, United States, 22015
    - Recruiting
    - Research Site
  - Williamsburg, Virginia, United States, 23188
    - Terminated
    - Research Site
- Wisconsin
  - Milwaukee, Wisconsin, United States, 53226
    - Recruiting
    - Research Site
  - Milwaukee, Wisconsin, United States, 53228
    - Recruiting
    - Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Description

Inclusion Criteria:

12 to 80 years of age, male and female, BMI <40 kg/m2; females must be not of childbearing potential or using a form of highly effective birth control.
Documented history of physician-diagnosed asthma > and/or = 1 year prior to V1.
Regularly using a stable daily ICS/LABA regimen (including a stable ICS dose) with medium-to-high ICS doses for at least 4 weeks prior to V1.
ACQ-7 total score ≥1.5 at Visits 1, 3, and 5 (pre-randomization).
FEV1 % (assessed as an average of the 60 and 30 minute pre-dose assessments) predicted normal at V1, 2, 3, 4, and 5 (pre-randomization)
- Participants > and/or = 18 years of age: < 80%
- Participants 12 to <18 years of age: < 90%
FEV1 post-albuterol at V2 or V3 (if repeat needed). • Participants > and/or = 18 years of age: Increase > and/or = 12% and > and/or = 200 mL.
- Participants 12 to <18 years of age: Increase =12% either in the 12 months prior to Visit 1 or at Visit 2, or at Visit 3.
- Note: Even if there is documented history of reversibility, all participants must be assessed for reversibility at Visit 2 (and Visit 3, if reversibility is not demonstrated at Visit 2) to provide reversibility baseline data for characterization.
Willing and, in the opinion of the Investigator, able to adjust current asthma therapy, as required by the protocol.
Demonstrate acceptable MDI/pMDI administration technique.
Received no asthma medication other than run-in BFF MDI BID and albuterol as needed during screening (except for allowed medications as defined in Table 9 and systemic corticosteroid or ICS for the treatment of an asthma exacerbation).
eDiary 14-day compliance ≥70% during screening (defined as completing the daily eDiary for any 10 mornings and any 10 evenings and answering "Yes" to taking 2 puffs of run-in BFF MDI for any 10 mornings and 10 evenings in the last 14 days prior to randomization).
No respiratory infection in the 4 weeks prior to randomization, or asthma exacerbation treated with systemic corticosteroid and/or additional ICS treatment in the 4 weeks prior to randomization.

Exclusion Criteria:

1. Completed treatment for respiratory infection or asthma exacerbation with systemic corticosteroids within 4 weeks of V1.

2a. Participants where, in the opinion of the Investigator, treatment with biological therapy for asthma would be appropriate.

2b. Any marketed or investigational biologics within 3 months or 5 halflives of V1, whichever is longer and must not be used during study duration.

3. Current smokers, former smokers with >10 pack-years history, or former smokers who stopped smoking <6 months prior to V1 (including all forms of tobacco, e-cigarettes or other vaping devices, and marijuana).

4. Current evidence of COPD.

5a. Oral and IV corticosteroid use (any dose) within 4 weeks of V1.

5b. Use of systemic corticosteroids for any other reason except for the acute treatment of severe asthma exacerbation is prohibited for the duration of the study.

5c. Depot corticosteroid use for any reason within 3 months of V1.

6. Use of LAMA, either alone or as part of an inhaled combination therapy, in the 12 weeks prior to Visit 1.

7. Use of oral beta2-agonist within 3 months of V1.

8. Use of any immunomodulators or immunosuppressive medication within 3 months or 5 half-lives, whichever is longer, and must not be used during the study duration.

9. Narrow angle glaucoma not adequately treated and/or change in vision that may be relevant, in the opinion of the Investigator, within 3 months of Visit 1.

10. Life-threatening asthma defined as a history of significant asthma episode(s) requiring intubation associated with hypercapnia, respiratory arrest, hypoxic seizures, or asthma-related syncopal episode(s).

11. Hospitalization for asthma within 2 months of Visit 1.

12. Known history of drug or alcohol abuse within 12 months of Visit 1.

13. Regular use of a nebulizer or a home nebulizer for receiving asthma medications.

14. Using any herbal products by inhalation or nebulizer within 4 weeks of Visit 1 and does not agree to stop during the study duration.

15. Participation in another clinical study with a study intervention administered in the last 30 days or 5 half-lives, whichever is longer. Any other study intervention that is not identified in the protocol is prohibited for use during study duration.

16. Participants with a known hypersensitivity to beta2-agonists, corticosteroids, anticholinergics, or any component of the MDI or pMDI.

17. Study Investigators, sub-Investigators, coordinators, and their employees or immediate family members.

18. For women only - currently pregnant (confirmed with positive highly sensitive pregnancy test), breast-feeding, or planned pregnancy during the study or not using acceptable contraception measures, as judged by the Investigator.

Please refer to the study protocol for the complete inclusion and exclusion criteria list

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Quadruple

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Budesonide, glycopyrronium, and formoterol fumarate (BGF) MDI 320/28.8/9.6 μg BGF MDI 320/28.8/9.6 μg Budesonide, glycopyrronium, and formoterol fumarate (PT010) Metered Dose Inhaler (MDI)	Drug: BGF MDI 320/28.8/9.6 μg Budesonide, glycopyrronium, and formoterol fumarate metered dose inhaler Other Names: BGF
Experimental: BGF MDI 320/14.4/9.6 μg BGF MDI 320/14.4/9.6 μg Budesonide, glycopyrronium, and formoterol fumarate (PT010) Metered Dose Inhaler (MDI)	Drug: BGF MDI 320/14.4/9.6 μg Budesonide, glycopyrronium, and formoterol fumarate metered dose inhaler Other Names: BGF
Active Comparator: Budesonide and formoterol fumarate (BFF) MDI 320/9.6 μg BFF MDI 320/9.6 μg (Experimental/Comparator) Budesonide and formoterol fumarate (PT009) Metered Dose Inhaler (MDI)	Drug: BFF MDI 320/9.6 μg Budesonide and formoterol fumarate metered dose inhaler Other Names: BFF
Active Comparator: Symbicort® Budesonide/ formoterol fumarate pressurized metered dose inhaler (pMDI) 320/9 μg	Drug: BFF pMDI 320/9 μg Budesonide/formoterol fumarate pressurized metered dose inhaler Other Names: Symbicort®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in forced expiratory volume in 1 second (FEV1) area under the curve 0 to 3 hours (AUC0-3) at Week 24 Time Frame: 24 Weeks	Change from baseline in forced expiratory volume in 1 second (FEV1) area under the curve 0 to 3 hours (AUC0-3) at Week 24	24 Weeks
Rate of severe asthma exacerbations Time Frame: Up to 52 Weeks	Primary end point(s) of Pooled Studies D5982C00007 and D5982C00008: Rate of severe asthma exacerbations	Up to 52 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in morning pre-dose trough FEV1 at Week 24 Time Frame: 24 Weeks	Change from baseline in morning pre-dose trough FEV1 at Week 24	24 Weeks
Percentage of responders in Asthma Control Questionnaire (ACQ)-7 (≥0.5 decrease equals response) at Week 24 Time Frame: 24 Weeks	Percentage of responders in ACQ-7 (≥0.5 decrease equals response) at Week 24. Additional analysis will be conducted using pooled data from studies D5982C00007 and D5982C00008	24 Weeks
Percentage of responders in ACQ-5 (≥0.5 decrease equals response) at Week 24 Time Frame: 24 Weeks	Percentage of responders in ACQ-5 (≥0.5 decrease equals response) at Week 24. Additional analysis will be conducted using pooled data from studies D5982C00007 and D5982C00008	24 Weeks
Percentage of responders in the St. George's Respiratory Questionnaire (SGRQ) (≥4.0 unit decrease equals response) at Week 24 Time Frame: 24 Weeks	Percentage of responders in the St. George's Respiratory Questionnaire (SGRQ) (≥4.0 unit decrease equals response) at Week 24	24 Weeks
Onset of action on Day 1: Absolute change in FEV1 at 5 minutes on Day 1 Time Frame: Day 1	Onset of action on Day 1: Absolute change in FEV1 at 5 minutes on Day 1	Day 1
Time to first severe asthma exacerbation Time Frame: Up to 52 Weeks	Secondary end point(s) of Pooled Studies D5982C00007 and D5982C00008: Time to first severe asthma exacerbation	Up to 52 Weeks
Rate of moderate/severe asthma exacerbations Time Frame: Up to 52 Weeks	Secondary end point(s) of Pooled Studies D5982C00007 and D5982C00008: Rate of moderate/severe asthma exacerbations	Up to 52 Weeks
Time to first moderate/severe asthma exacerbation Time Frame: Up to 52 Weeks	Secondary end point(s) of Pooled Studies D5982C00007 and D5982C00008: Time to first moderate/severe asthma exacerbation	Up to 52 Weeks
Percentage of responders in the Asthma Quality of Life Questionnaire for 12 years and older (AQLQ +12) (≥0.5 increase equals response) at Week 24 Time Frame: 24 Weeks	Percentage of responders in the Asthma Quality of Life Questionnaire for 12 years and older (AQLQ(s) +12) (≥0.5 increase equals response) at Week 24. Additional analysis will be conducted using pooled data from studies D5982C00007 and D5982C00008	24 Weeks
Rate of severe asthma exacerbations for participants with percent predicted FEV1 ≤ 55% at baseline. Time Frame: Up to 52 Weeks	Secondary end point(s) of Pooled Studies D5982C00007 and D5982C00008: Rate of severe asthma exacerbations for participants with percent predicted FEV1 ≤ 55% at baseline.	Up to 52 Weeks
Rate of severe asthma exacerbations for participants with ≥ 1 severe exacerbation in the 12 months prior to Visit 1. Time Frame: Up to 52 Weeks	Secondary end point(s) of Pooled Studies D5982C00007 and D5982C00008: Rate of severe asthma exacerbations for participants with ≥ 1 severe exacerbation in the 12 months prior to Visit 1.	Up to 52 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

Principal Investigator: Robert Wise, MD, Johns Hopkins University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2021

Primary Completion (Estimated)

March 21, 2025

Study Completion (Estimated)

March 21, 2025

Study Registration Dates

First Submitted

October 26, 2020

First Submitted That Met QC Criteria

October 26, 2020

First Posted (Actual)

October 30, 2020

Study Record Updates

Last Update Posted (Actual)

February 14, 2024

Last Update Submitted That Met QC Criteria

February 13, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

D5982C00008
2020-001521-31 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

IPD Sharing Time Frame

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

IPD Sharing Access Criteria

When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

IPD Sharing Supporting Information Type

STUDY_PROTOCOL
SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Study to Assess the Efficacy and Safety of PT010 Relative to PT003 and PT009 in Subjects With Moderate to Very Severe COPD (Ethos)

COPD

United States, Austria, Canada, France, Germany, Italy, Netherlands, Spain, Sweden, United Kingdom, Peru, Russian Federation, Hungary, China, Taiwan, Australia, Japan, Argentina, South Africa, Belgium, Czechia, Serbia, Poland, Mexico, New... and more
AstraZeneca

Active, not recruiting

A Study to Assess the Safety of Budesonide/Glycopyrronium/Formoterol Fumarate With the Hydrofluoroolefin Propellant in Participants With Moderate to Very Severe Chronic Obstructive Pulmonary Disease

Chronic Obstructive Pulmonary Disease (COPD)

United States, Canada, Germany, Argentina, Bulgaria, Poland, Turkey, Mexico, United Kingdom
Pearl Therapeutics, Inc.

Completed

Study to Assess the Safety and Tolerability of PT010, PT009 and PT003 in Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease

COPD

United States
AstraZeneca

Recruiting

A Study Evaluating the Efficacy of Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dosed Inhaler on Cardiopulmonary Outcomes in Chronic Obstructive Pulmonary Disease (THARROS)

COPD (Chronic Obstructive Pulmonary Disease)

France, Denmark, Italy, Spain, United States, Canada, Argentina, Japan, Colombia, Germany, Peru, Brazil, China, India, Thailand, Austria, Serbia, Malaysia, Philippines, Poland, Taiwan, Greece, Norway, Sweden, Mexico, Romania, Korea, Republic... and more
Pearl Therapeutics, Inc.

Completed

A Randomized, Double-Blind, Parallel-Group, 24-Week, Chronic-Dosing, Multi-Center Study to Assess the Efficacy and Safety of PT010, PT003, and PT009 Compared With Symbicort® Turbuhaler® (Kronos) (KRONOS)

COPD

United States, Canada, China, Japan
Pearl Therapeutics, Inc.

Completed

Efficacy and Safety Study of PT009, PT008, and PT005 in Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) (PT009001)

Chronic Obstructive Pulmonary Disease

United States
Pearl Therapeutics, Inc.

Withdrawn

To Assess the Efficacy and Safety of PT010 Compared to PT009 in Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease

Chronic Obstructive Pulmonary Disease
AstraZeneca

Recruiting

A 24-Week Efficacy and Safety Study to Assess Budesonide and Formoterol Fumarate Metered Dose Inhaler in Adult and Adolescent Participants With Inadequately Controlled Asthma (VATHOS) (VATHOS)

Asthma

United States, Canada, Italy, Japan, Vietnam, Spain, Germany, Malaysia
AstraZeneca

Recruiting

A 12-week Study to Assess the Efficacy and Safety of Budesonide and Formoterol Fumarate Metered Dose Inhaler Relative to Budesonide Metered Dose Inhaler in Participants With Inadequately Controlled Asthma (LITHOS) (LITHOS)

Asthma

United States, Canada, South Africa, Korea, Republic of, Philippines, Czechia, Malaysia, Germany

Study to Assess PT010 in Adult and Adolescent Participants With Inadequately Controlled Asthma (LOGOS) (LOGOS)

A Randomized, Double-Blind, Double Dummy, Parallel Group, Multicenter Variable Length Study to Assess the Efficacy and Safety of PT010 Relative to PT009 and Symbicort® in Adult and Adolescent Participants With Inadequately Controlled Asthma

Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Estimated)

Phase

Contacts and Locations

Study Contact

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Investigators

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Estimated)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

IPD Sharing Time Frame

IPD Sharing Access Criteria

IPD Sharing Supporting Information Type

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

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