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

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: Completed
• Conditions: Asthma
• Intervention / Treatment: Drug: BGF MDI 320/28.8/9.6 μg; Drug: BGF MDI 320/14.4/9.6 μg; Drug: BFF MDI 320/9.6 μg; Drug: BFF pMDI 320/9 μg

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 (Actual): 2187
• Phase: Phase 3

Contacts and Locations

Study Locations

• Brazil
  • Botucatu, Brazil, 18618-970
    • Research Site
  • Porto Alegre, Brazil, 90610-000
    • Research Site
  • Porto Alegre, Brazil, 91350-200
    • Research Site
  • Porto Alegre, Brazil, 9002-060
    • Research Site
  • Porto Alegre, Brazil, 90430-001
    • Research Site
  • Santo André, Brazil, 09080-110
    • Research Site
  • Sorocaba, Brazil, 18040-425
    • Research Site
  • São Paulo, Brazil, 05403-000
    • Research Site
• China
  • Baotou, China, 014010
    • Research Site
  • Beijing, China, 100020
    • Research Site
  • Changsha, China, 410008
    • Research Site
  • Changsha, China, 430033
    • Research Site
  • Changsha, China, 410005
    • Research Site
  • Changzhi, China, 46000
    • Research Site
  • Chengdu, China, 611130
    • Research Site
  • Chengdu, China, 610072
    • Research Site
  • Chizhou, China, 247099
    • Research Site
  • Chongqing, China, 400038
    • Research Site
  • Chongqing, China, 400010
    • Research Site
  • Dongguan, China, 523413
    • Research Site
  • Dongyang, China, 322100
    • Research Site
  • Fuzhou, China, 350025
    • Research Site
  • Guangzhou, China, 510120
    • Research Site
  • Guangzhou, China, 510180
    • Research Site
  • Guangzhou, China, 510100
    • Research Site
  • Guangzhou, China, 510630
    • Research Site
  • Guangzhou, China, 510062
    • Research Site
  • Guangzhou, China, 510280
    • Research Site
  • Haikou, China, 570311
    • Research Site
  • Haikou, China, 570208
    • Research Site
  • Hangzhou, China, 310005
    • Research Site
  • Hangzhou, China, 310009
    • Research Site
  • Hefei, China, 230000
    • Research Site
  • Hefei, China, 230011
    • Research Site
  • Hefei, China, 230061
    • Research Site
  • Huai'an, China, 223300
    • Research Site
  • Huizhou, China, 516001
    • Research Site
  • Jinan, China, 250014
    • Research Site
  • Jinhua, China, 321000
    • Research Site
  • Kunming, China, 650032
    • Research Site
  • Kunming, China, 650051
    • Research Site
  • Lanzhou, China, 730000
    • Research Site
  • Liuzhou, China, 545006
    • Research Site
  • Luoyang, China, 471003
    • Research Site
  • Nanchang, China, 330006
    • Research Site
  • Nanchong, China, 637000
    • Research Site
  • Nanjing, China, 210009
    • Research Site
  • Nanjing, China, 210029
    • Research Site
  • Nanjing, China, 210006
    • Research Site
  • Nanjing, China, 210008
    • Research Site
  • Nanning, China, 530021
    • Research Site
  • Qingdao, China, 266000
    • Research Site
  • Qingdao, China, 266042
    • Research Site
  • Shanghai, China, 200032
    • Research Site
  • Shanghai, China, 200080
    • Research Site
  • Shanghai, China, 200025
    • Research Site
  • Shanghai, China, 201199
    • Research Site
  • Shanghai, China, 200065
    • Research Site
  • Shanghai, China, 200092
    • Research Site
  • Shanghai, China, 200240
    • Research Site
  • Shaoxing, China, 312000
    • Research Site
  • Shengyang, China, 110004
    • Research Site
  • Shenyang, China, 110001
    • Research Site
  • Shenyang, China, 110015
    • Research Site
  • Shenyang, China, 110075
    • Research Site
  • Shenzhen, China, 518039
    • Research Site
  • Shenzhen, China, 518036
    • Research Site
  • Shenzhen, China, 518020
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  • Shijiazhuang, China, 50051
    • Research Site
  • Taiyuan, China, 030001
    • Research Site
  • Taiyuan, China, 030032
    • Research Site
  • Taizhou, China, 318020
    • Research Site
  • Weifang, China, 261000
    • Research Site
  • Wuhan, China, 430030
    • Research Site
  • Wuhan, China, 430010
    • Research Site
  • Wuhu, China, 241000
    • Research Site
  • Xi'an, China, 710004
    • Research Site
  • Xi'an, China, 710077
    • Research Site
  • Xinxiang, China, 453002
    • Research Site
  • Xuzhou, China, 221009
    • Research Site
  • Xuzhou, China, 221000
    • Research Site
  • Yangzhou, China, 225001
    • Research Site
  • Yantai, China, 264000
    • Research Site
  • Yinchuan, China, 750001
    • Research Site
  • Yinchuan, China, 750004
    • Research Site
  • Yueyang, China, 414000
    • Research Site
  • Zhangzhou, China, 363099
    • Research Site
  • Zhanjiang, China, 524001
    • Research Site
  • Zhengzhou, China, 450000
    • Research Site
  • Zhuji, China, 311899
    • Research Site
  • Ürümqi, China, 830054
    • Research Site
• Colombia
  • Barranquilla, Colombia, 080020
    • Research Site
  • Bogotá, Colombia, 110221
    • Research Site
  • Cartagena, Colombia, 130013
    • Research Site
  • Medellín, Colombia, 050621
    • Research Site
  • Rionegro, Colombia, 054047
    • Research Site
• Czechia
  • Brandýs nad Labem, Czechia, 250 01
    • Research Site
  • Jindřichův Hradec, Czechia, 377 01
    • Research Site
  • Lovosice, Czechia, 410 02
    • Research Site
  • Mladá Boleslav, Czechia, 293 01
    • Research Site
  • Nový Bor, Czechia, 473 01
    • Research Site
  • Prague, Czechia, 190 00
    • Research Site
  • Prague, Czechia, 148 00
    • Research Site
  • Rokycany, Czechia, 337 22
    • Research Site
  • Strakonice, Czechia, 38601
    • Research Site
  • Teplice, Czechia, 415 01
    • Research Site
  • Varnsdorf, Czechia, 407 47
    • Research Site
• Germany
  • Bamberg, Germany, 96049
    • Research Site
  • Berlin, Germany, 10367
    • Research Site
  • Berlin, Germany, 10717
    • Research Site
  • Berlin, Germany, 10119
    • Research Site
  • Berlin, Germany, 10787
    • Research Site
  • Berlin, Germany, 12203
    • Research Site
  • Berlin, Germany, 13187
    • Research Site
  • Berlin, Germany, 12159
    • Research Site
  • Darmstadt, Germany, 64283
    • Research Site
  • Frankfurt, Germany, 60596
    • Research Site
  • Frankfurt am Main, Germany, 60596
    • Research Site
  • Frankfurt am Main, Germany, 60389
    • Research Site
  • Fürstenwalde, Germany, 15517
    • Research Site
  • Geesthacht, Germany, 21502
    • Research Site
  • Hanover, Germany, 30449
    • Research Site
  • Hanover, Germany, D-30173
    • Research Site
  • Heidelberg, Germany, 69115
    • Research Site
  • Koblenz, Germany, 56068
    • Research Site
  • Landsberg, Germany, 86899
    • Research Site
  • Leipzig, Germany, 04103
    • Research Site
  • Leipzig, Germany, 04207
    • Research Site
  • Leipzig, Germany, 04299
    • Research Site
  • Mainz, Germany, 55128
    • Research Site
  • München-Pasing, Germany, 81241
    • Research Site
  • Witten, Germany, 58452
    • Research Site
• Greece
  • Alexandroupoli, Greece, 68100
    • Research Site
  • Athens, Greece, 11527
    • Research Site
  • Athens, Greece, 12462
    • Research Site
  • Athens, Greece, 11521
    • Research Site
  • Athens, Greece, 17562
    • Research Site
  • Corfu, Greece, 49100
    • Research Site
  • Exohi Thessaloniki, Greece, 57010
    • Research Site
  • Ioannina, Greece, 45500
    • Research Site
  • Pátrai, Greece, 26500
    • Research Site
  • Thessaloniki, Greece, 57010
    • Research Site
  • Thessaloniki, Greece, 56429
    • Research Site
• Israel
  • Ashkelon, Israel, 7830604
    • Research Site
  • Beersheba, Israel, 84101
    • Research Site
  • Haifa, Israel, 34362
    • Research Site
  • Haifa, Israel, 31096
    • Research Site
  • Holon, Israel, 5837738
    • Research Site
  • Jerusalem, Israel, 9112001
    • Research Site
  • Jerusalem, Israel, 9103102
    • Research Site
  • Kfar Saba, Israel, 4428164
    • Research Site
  • Petah Tikva, Israel, 4920235
    • Research Site
  • Rehovot, Israel, 76100
    • Research Site
  • Tel Aviv, Israel, 6423906
    • Research Site
• Mexico
  • Cuernavaca, Mexico, 62290
    • Research Site
  • Durango, Mexico, 43080
    • Research Site
  • Guadalajara, Mexico, 44200
    • Research Site
  • Mazatlán, Mexico, 82000
    • Research Site
  • Monterrey, Mexico, 64710
    • Research Site
  • Monterrey, Mexico, 64620
    • Research Site
  • Monterrey, Mexico, 64718
    • Research Site
  • Mérida, Mexico, 97070
    • Research Site
  • Veracruz, Mexico, 91910
    • Research Site
  • Villahermosa, Mexico, 86035
    • Research Site
  • Zapopan, Mexico, 45138
    • Research Site
• Portugal
  • Amadora, Portugal, 2720-276
    • Research Site
  • Braga, Portugal, 4710
    • Research Site
  • Coimbra, Portugal, 3040-316
    • Research Site
  • Figueira da Foz Municipality, Portugal, 3094-001
    • Research Site
  • Guimarães, Portugal, 4835-044
    • Research Site
  • Lisbon, Portugal, 1649-035
    • Research Site
  • Lisbon, Portugal, 1998-018
    • Research Site
  • Matosinhos Municipality, Portugal, 4454-509
    • Research Site
• Puerto Rico
  • Ponce, Puerto Rico, 00717
    • Research Site
  • Ponce, Puerto Rico, 00780
    • Research Site
• Russia
  • Chelyabinsk, Russia, 454106
    • Research Site
  • Izhevsk, Russia, 426035
    • Research Site
  • Kazan', Russia, 420008
    • Research Site
  • Kemerovo, Russia, 650002
    • Research Site
  • Moscow, Russia, 125284
    • Research Site
  • Moscow, Russia, 115522
    • Research Site
  • Omsk, Russia, 644050
    • Research Site
  • Penza, Russia, 440067
    • Research Site
  • Perm, Russia, 614000
    • Research Site
  • Saint Petersburg, Russia, 194354
    • Research Site
  • Saint Petersburg, Russia, 195257
    • Research Site
  • Saratov, Russia, 410028
    • Research Site
  • Saratov, Russia, 410053
    • Research Site
  • Tomsk, Russia, 634050
    • Research Site
  • Ulyanovsk, Russia, 432009
    • Research Site
• Slovakia
  • Bojnice, Slovakia, 972 01
    • Research Site
  • Kežmarok, Slovakia, 060 01
    • Research Site
  • Košice, Slovakia, 04022
    • Research Site
  • Levice, Slovakia, 934 01
    • Research Site
  • Levice, Slovakia, 93401
    • Research Site
  • Nové Zámky, Slovakia, 94001
    • Research Site
  • Poprad, Slovakia, 058 01
    • Research Site
  • Prešov, Slovakia, 081 81
    • Research Site
  • Ružomberok, Slovakia, 034 26
    • Research Site
  • Topoľčany, Slovakia, 95501
    • Research Site
  • Šurany, Slovakia, 94201
    • Research Site
  • Žilina, Slovakia, 010 01
    • Research Site
• South Africa
  • Bloemfontein, South Africa, 9301
    • Research Site
  • Cape Town, South Africa, 7700
    • Research Site
  • Cape Town, South Africa, 7764
    • Research Site
  • Durban, South Africa, 4001
    • Research Site
  • Durban, South Africa, 4091
    • Research Site
  • Durban, South Africa, 4450
    • Research Site
  • Durban, South Africa, 4093
    • Research Site
  • Johannesburg, South Africa, 2001
    • Research Site
  • Lenasia, South Africa, 1821
    • Research Site
  • Lenasia Ext8, South Africa, 1820
    • Research Site
  • Panorama, South Africa, 7500
    • Research Site
  • Pretoria, South Africa, 0186
    • Research Site
  • Tygervalley, South Africa, 7530
    • Research Site
  • eMkhomazi, South Africa, 4170
    • Research Site
• Turkey (Türkiye)
  • Adana, Turkey (Türkiye), 1260
    • Research Site
  • Ankara, Turkey (Türkiye), 06
    • Research Site
  • Istanbul, Turkey (Türkiye), 34098
    • Research Site
  • Istanbul, Turkey (Türkiye), 34844
    • Research Site
  • Izmir, Turkey (Türkiye), 35110
    • Research Site
  • Mersin, Turkey (Türkiye), 33343
    • Research Site
  • Pamukkale, Turkey (Türkiye), 20070
    • Research Site
• United Kingdom
  • Blackpool, United Kingdom, FY3 7EN
    • Research Site
  • Bradford, United Kingdom, BD9 6RJ
    • Research Site
  • Corby, United Kingdom, NN17 2UR
    • Research Site
  • Hull, United Kingdom, HU16 5JQ
    • Research Site
  • Leicester, United Kingdom, LE5 4LJ
    • Research Site
  • Rhyl, United Kingdom, LL18 1DA
    • Research Site
• United States
  • Arizona
    • Chandler, Arizona, United States, 85224
      • Research Site
    • Tempe, Arizona, United States, 85283
      • Research Site
    • Tucson, Arizona, United States, 85741
      • Research Site
  • Arkansas
    • Hot Springs, Arkansas, United States, 71913
      • Research Site
  • California
    • Bakersfield, California, United States, 93301
      • Research Site
    • Carlsbad, California, United States, 92008
      • Research Site
    • Huntington Beach, California, United States, 92647
      • Research Site
    • Lancaster, California, United States, 93534
      • Research Site
    • Long Beach, California, United States, 90815
      • Research Site
    • Mission Viejo, California, United States, 92691
      • Research Site
    • North Hollywood, California, United States, 91606
      • Research Site
    • Northridge, California, United States, 91324
      • Research Site
    • Rancho Cucamonga, California, United States, 91730
      • Research Site
    • Sacramento, California, United States, 95823
      • Research Site
    • San Diego, California, United States, 92123
      • Research Site
    • San Jose, California, United States, 95117
      • Research Site
    • Ventura, California, United States, 93003
      • Research Site
    • Walnut Creek, California, United States, 94598
      • Research Site
  • Colorado
    • Colorado Springs, Colorado, United States, 80907
      • Research Site
    • Colorado Springs, Colorado, United States, 80910
      • Research Site
    • Wheat Ridge, Colorado, United States, 80033
      • Research Site
  • Delaware
    • Newark, Delaware, United States, 19713
      • Research Site
  • Florida
    • Boca Raton, Florida, United States, 33487
      • Research Site
    • Clearwater, Florida, United States, 33765
      • Research Site
    • Clearwater, Florida, United States, 33756
      • Research Site
    • Cutler Bay, Florida, United States, 33189
      • Research Site
    • DeBary, Florida, United States, 32713
      • Research Site
    • Hialeah, Florida, United States, 33016
      • Research Site
    • Lakeland, Florida, United States, 33813
      • Research Site
    • Miami, Florida, United States, 33135
      • Research Site
    • Tampa, Florida, United States, 33615
      • Research Site
  • Georgia
    • Acworth, Georgia, United States, 30101
      • Research Site
    • Atlanta, Georgia, United States, 30322
      • Research Site
    • Atlanta, Georgia, United States, 30350
      • Research Site
    • Snellville, Georgia, United States, 30078
      • Research Site
  • Idaho
    • Boise, Idaho, United States, 83706
      • Research Site
  • Illinois
    • Chicago, Illinois, United States, 60621
      • Research Site
    • Normal, Illinois, United States, 61761
      • Research Site
    • Peoria, Illinois, United States, 61636
      • Research Site
  • Indiana
    • Evansville, Indiana, United States, 47715
      • Research Site
  • Louisiana
    • Marrero, Louisiana, United States, 70072
      • Research Site
    • Zachary, Louisiana, United States, 70791
      • Research Site
  • Maryland
    • Baltimore, Maryland, United States, 21224
      • Research Site
    • White Marsh, Maryland, United States, 21162
      • Research Site
  • Massachusetts
    • Fall River, Massachusetts, United States, 02723
      • Research Site
  • Michigan
    • Farmington Hills, Michigan, United States, 48336
      • Research Site
    • Rochester, Michigan, United States, 48307
      • Research Site
    • Troy, Michigan, United States, 48085
      • Research Site
  • Missouri
    • St Louis, Missouri, United States, 63141
      • Research Site
    • Warrensburg, Missouri, United States, 64093
      • Research Site
  • Nevada
    • North Las Vegas, Nevada, United States, 89030
      • Research Site
  • New Hampshire
    • Portsmouth, New Hampshire, United States, 03801
      • Research Site
  • New Jersey
    • Ocean City, New Jersey, United States, 07712
      • Research Site
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • Research Site
  • New York
    • Brooklyn, New York, United States, 11236
      • Research Site
    • The Bronx, New York, United States, 10461
      • Research Site
    • The Bronx, New York, United States, 10459
      • Research Site
    • The Bronx, New York, United States, 10468
      • Research Site
  • North Carolina
    • Greensboro, North Carolina, United States, 27405
      • Research Site
    • Huntersville, North Carolina, United States, 28078
      • Research Site
    • Monroe, North Carolina, United States, 28112
      • Research Site
  • Ohio
    • Columbus, Ohio, United States, 43215
      • Research Site
  • Oregon
    • Portland, Oregon, United States, 97202
      • Research Site
  • Pennsylvania
    • Jenkintown, Pennsylvania, United States, 19046
      • Research Site
    • Philadelphia, Pennsylvania, United States, 19107
      • Research Site
  • South Carolina
    • Spartanburg, South Carolina, United States, 29303
      • Research Site
  • Tennessee
    • Knoxville, Tennessee, United States, 37909
      • Research Site
  • Texas
    • Amarillo, Texas, United States, 79106
      • Research Site
    • Cedar Park, Texas, United States, 78613
      • Research Site
    • Dallas, Texas, United States, 75254
      • Research Site
    • Denison, Texas, United States, 75020
      • Research Site
    • Forney, Texas, United States, 75126
      • Research Site
    • Houston, Texas, United States, 77074
      • Research Site
    • Houston, Texas, United States, 77099
      • Research Site
    • Lewisville, Texas, United States, 75067
      • Research Site
    • McKinney, Texas, United States, 75069
      • Research Site
    • North Richland Hills, Texas, United States, 76180
      • Research Site
    • Pearland, Texas, United States, 77584
      • Research Site
    • Plano, Texas, United States, 75093
      • Research Site
    • San Antonio, Texas, United States, 78258
      • Research Site
    • Sugar Land, Texas, United States, 77478
      • Research Site
    • Victoria, Texas, United States, 77901
      • Research Site
  • Utah
    • Roy, Utah, United States, 84067
      • Research Site
  • Virginia
    • Abingdon, Virginia, United States, 24210
      • Research Site
    • Burke, Virginia, United States, 22015
      • Research Site
    • Williamsburg, Virginia, United States, 23188
      • Research Site
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Research Site
    • Milwaukee, Wisconsin, United States, 53228
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 80 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 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.
2. Documented history of physician-diagnosed asthma > and/or = 1 year prior to V1.
3. 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.
4. ACQ-7 total score ≥1.5 at Visits 1, 3, and 5 (pre-randomization).

5. 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%

6. 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.
7. Willing and, in the opinion of the Investigator, able to adjust current asthma therapy, as required by the protocol.
8. Demonstrate acceptable MDI/pMDI administration technique.
9. 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).
10. 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).
11. 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

How is the study designed?

Design Details

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

Number of Arms

4

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 FEV1 AUC0-3 (L) at Week 24	Change from baseline in forced expiratory volume in 1 second (FEV1) area under the curve 0 to 3 hours (AUC0-3) at Week 24. Treatment policy was implemented to handle all intercurrent events (ICEs) with the exception of initiation of new asthma therapy or use of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of study intervention, for which the composite strategy was implemented.	Week 24
Pooled (LOGOS/KALOS): Rate of Severe Asthma Exacerbations	Rate of severe asthma exacerbations was assessed in a pre-specified pooled analysis across replicate studies D5982C00008 and D5982C00007 (NCT04609878). An asthma exacerbation was severe if it resulted in at least 1 of the following: systemic corticosteroids for 3 days, an ER/urgent care visit requiring systemic corticosteroids, a hospitalization, or death related to asthma. Consecutive exacerbations with start/stop days ≤7 days apart were considered the same event. Treatment policy was implemented to handle all ICEs with the exception of initiation of new asthma therapy or use of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of study intervention, for which the composite strategy was implemented.	Up to 52 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Responders in SGRQ (≥4.0 Decrease Equals Response) at Week 24	Percentage of responders in the St. George's Respiratory Questionnaire (SGRQ) (≥4.0 decrease equals response) at Week 24. Treatment policy was implemented to handle all ICEs with the exception of initiation of new asthma therapy or use of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of study intervention, for which the composite strategy was implemented.	Week 24
Change From Baseline in Morning Pre-dose Trough FEV1 (L) at Week 24	Change from baseline in morning pre-dose trough FEV1 at Week 24. Treatment policy was implemented to handle all ICEs with the exception of initiation of new asthma therapy or use of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of study intervention, for which the composite strategy was implemented.	Week 24
Onset of Action on Day 1: Absolute Change in FEV1 (L) at 5 Minutes on Day 1	Onset of action on Day 1: Absolute change in FEV1 (L) at 5 minutes on Day 1. Treatment policy was implemented to handle all ICEs with the exception of initiation of new asthma therapy or use of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of study intervention, for which the composite strategy was implemented.	Day 1
Percentage of Responders in ACQ-7 (≥0.5 Decrease Equals Response) at Week 24	Percentage of responders in Asthma Control Questionnaire (ACQ)-7 (≥0.5 decrease equals response) at Week 24. Treatment policy was implemented to handle all ICEs with the exception of initiation of new asthma therapy or use of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of study intervention, for which the composite strategy was implemented.	Week 24
Percentage of Responders in ACQ-5 (≥0.5 Decrease Equals Response) at Week 24	Percentage of responders in ACQ-5 (≥0.5 decrease equals response) at Week 24. Treatment policy was implemented to handle all ICEs with the exception of initiation of new asthma therapy or use of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of study intervention, for which the composite strategy was implemented.	Week 24
Percentage of Responders in AQLQ(s) +12 (≥0.5 Increase Equals Response) at Week 24	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. Treatment policy was implemented to handle all ICEs with the exception of initiation of new asthma therapy or use of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of study intervention, for which the composite strategy was implemented.	Week 24
Pooled (LOGOS/KALOS): Rate of Severe Asthma Exacerbations for Participants With Percent Predicted FEV1 ≤55% at Baseline	Rate of severe asthma exacerbations for participants with percent predicted FEV1 ≤55% at baseline was assessed in a pre-specified pooled analysis across replicate studies D5982C00008 and D5982C00007 (NCT04609878). An asthma exacerbation was severe if it resulted in at least 1 of the following: systemic corticosteroids for 3 days, an ER/urgent care visit requiring systemic corticosteroids, a hospitalization, or death related to asthma. Consecutive exacerbations with start/stop days ≤7 days apart were considered the same event. Treatment policy was implemented to handle all ICEs with the exception of initiation of new asthma therapy or use of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of study intervention, for which the composite strategy was implemented.	Up to 52 Weeks
Pooled (LOGOS/KALOS): Rate of Severe Asthma Exacerbations for Participants With ≥1 Severe Exacerbation in the 12 Months Prior to Visit 1	Rate of severe asthma exacerbations for participants with ≥1 severe exacerbation in the 12 months prior to Visit 1 was assessed in a pre-specified pooled analysis across replicate studies D5982C00008 and D5982C00007 (NCT04609878). An asthma exacerbation was severe if it resulted in at least 1 of the following: systemic corticosteroids for 3 days, an ER/urgent care visit requiring systemic corticosteroids, a hospitalization, or death related to asthma. Consecutive exacerbations with start/stop days ≤7 days apart were considered the same event. Treatment policy was implemented to handle all ICEs with the exception of initiation of new asthma therapy or use of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of study intervention, for which the composite strategy was implemented.	Up to 52 Weeks
Pooled (LOGOS/KALOS): Time to First Severe Asthma Exacerbation	Time to first severe asthma exacerbation was assessed in a pre-specified pooled analysis across replicate studies D5982C00008 and D5982C00007 (NCT04609878). Time to first severe asthma exacerbation was the time from the first dose of study medication to the time of onset of the first severe asthma exacerbation. Treatment policy was implemented to handle all ICEs with the exception of initiation of new asthma therapy or use of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of study intervention, for which the composite strategy was implemented.	Up to 52 weeks
Pooled (LOGOS/KALOS): Rate of Moderate or Severe Asthma Exacerbations	Rate of moderate/severe exacerbations was assessed in a pre-specified pooled analysis across replicate studies D5982C00008 and D5982C00007 (NCT04609878). An exacerbation was severe if it resulted in at least 1 of the following: systemic corticosteroids for 3 days, an ER/urgent care visit requiring systemic corticosteroids, an inpatient hospitalization, or death related to asthma. A moderate exacerbation was a worsening of symptoms that resulted in additional ICS for 3 days. Consecutive exacerbations with start/stop days ≤7 days apart were considered the same event. Treatment policy was implemented to handle all ICEs with the exception of initiation of new asthma therapy or use of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of study intervention, for which the composite strategy was implemented.	Up to 52 Weeks
Pooled (LOGOS/KALOS): Time to First Moderate or Severe Asthma Exacerbation	Time to first moderate/severe asthma exacerbation was assessed in a pre-specified pooled analysis across replicate studies D5982C00008 and D5982C00007 (NCT04609878). Time to first moderate or severe asthma exacerbation was the time from the first dose of study medication to the time of onset of the first moderate/severe asthma exacerbation. Treatment policy was implemented to handle all ICEs with the exception of initiation of new asthma therapy or use of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of study intervention, for which the composite strategy was implemented.	Up to 52 weeks
Pooled (LOGOS/KALOS): Percentage of Responders in ACQ-7 (≥0.5 Decrease Equals Response) at Week 24	Percentage of responders in ACQ-7 (≥0.5 decrease equals response) at Week 24 was assessed in a pre-specified pooled analysis across replicate studies D5982C00008 and D5982C00007 (NCT04609878). Treatment policy was implemented to handle all ICEs with the exception of initiation of new asthma therapy or use of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of study intervention, for which the composite strategy was implemented.	Week 24
Pooled (LOGOS/KALOS): Percentage of Responders in ACQ-5 (≥0.5 Decrease Equals Response) at Week 24	Percentage of responders in ACQ-5 (≥0.5 decrease equals response) at Week 24 was assessed in a pre-specified pooled analysis across replicate studies D5982C00008 and D5982C00007 (NCT04609878). Treatment policy was implemented to handle all ICEs with the exception of initiation of new asthma therapy or use of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of study intervention, for which the composite strategy was implemented.	Week 24
Pooled (LOGOS/KALOS): Percentage of Responders in AQLQ(s) +12 (≥0.5 Increase Equals Response) at Week 24	Percentage of responders in AQLQ(s) +12 (≥0.5 increase equals response) at Week 24 was assessed in a pre- specified pooled analysis across replicate studies D5982C00008 and D5982C00007 (NCT04609878). Treatment policy was implemented to handle all ICEs with the exception of initiation of new asthma therapy or use of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of study intervention, for which the composite strategy was implemented.	Week 24

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Principal Investigator: Robert Wise, MD, Johns Hopkins University

Publications and helpful links

General Publications

• Oba Y, Anwer S, Maduke T, Patel T, Dias S. Effectiveness and tolerability of dual and triple combination inhaler therapies compared with each other and varying doses of inhaled corticosteroids in adolescents and adults with asthma: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2022 Dec 6;12(12):CD013799. doi: 10.1002/14651858.CD013799.pub2.
• Papi A, Wise RA, Jackson DJ, Lugogo N, Chen R, Trasieva T, Obasi C, Movitz C, Helman J, Salter P, Springer K, Bondoc M, Shah M, Knappenberger K, Bowen K, Pandya H, Megally A, Patel M; KALOS and LOGOS study investigators. Budesonide-glycopyrronium-formoterol fumarate dihydrate in uncontrolled asthma (KALOS and LOGOS): twin multicentre, double-blind, double-dummy, parallel-group, randomised, phase 3 trials. Lancet Respir Med. 2026 Apr;14(4):350-362. doi: 10.1016/S2213-2600(25)00457-6. Epub 2026 Feb 12.

Helpful Links

• D5982C00008_CSP_Redacted
• D5982C00008_D5982C00007_SAP_Redacted
• D5982C00008_CSR Synopsis_Redacted

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Actual): March 20, 2025
• Study Completion (Actual): March 20, 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): July 2, 2026
• Last Update Submitted That Met QC Criteria: June 8, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Asthma; Organic Chemicals; Pharmaceutical Preparations; Polycyclic Compounds; Amines; Pregnanes; Steroids; Fused-Ring Compounds; Alcohols; Amino Alcohols; Ethanolamines; Pregnenediones; Pregnenes; Drug Combinations; Formoterol Fumarate; Budesonide; Budesonide, Formoterol Fumarate Drug Combination
• Other Study ID Numbers: D5982C00008; 2020-001521-31 (EudraCT Number); 2023-505786-88 (Registry Identifier: CTIS)

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: No