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

June 23, 2026 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

Completed

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 (Actual)

2274

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 Locations

Argentina
- - Buenos Aires, Argentina, C1121ABE
    - Research Site
  - CABA, Argentina, C1425BEN
    - Research Site
  - CABA, Argentina, 1056
    - Research Site
  - Ciudad de Buenos Aires, Argentina, 1425
    - Research Site
  - Ciudad de Buenos Aires, Argentina, C1280AEB
    - Research Site
  - Ciudad de Buenos Aires, Argentina, C1414AIF
    - Research Site
  - Córdoba, Argentina, X5003DCE
    - Research Site
  - Florida, Argentina, B1602DQD
    - Research Site
  - Mar del Plata, Argentina, 7600
    - Research Site
  - Mendoza, Argentina, M5500CCG
    - Research Site
  - Ranelagh, Argentina, 1886
    - Research Site
  - Rosario, Argentina, 2000
    - Research Site
  - Rosario, Argentina, S2000DEJ
    - Research Site
  - San Fernando, Argentina, B1646EBJ
    - Research Site
Belgium
- - Liège, Belgium, 4000
    - Research Site
  - Namur, Belgium, 5101
    - Research Site
Bulgaria
- - Dupnitsa, Bulgaria, 2600
    - Research Site
  - Dupnitsa, Bulgaria, 2602
    - Research Site
  - Haskovo, Bulgaria, 6305
    - Research Site
  - Kozloduy, Bulgaria, 3320
    - Research Site
  - Lovech, Bulgaria, 5500
    - Research Site
  - Pazardzhik, Bulgaria, 4400
    - Research Site
  - Petrich, Bulgaria, 2850
    - Research Site
  - Pleven, Bulgaria, 5800
    - Research Site
  - Rousse, Bulgaria, 7002
    - Research Site
  - Rousse, Bulgaria, 7000
    - Research Site
  - Sevlievo, Bulgaria, 5403
    - Research Site
  - Sliven, Bulgaria, 8800
    - Research Site
  - Smolyan, Bulgaria, 3700
    - Research Site
  - Sofia, Bulgaria, 1000
    - Research Site
  - Sofia, Bulgaria, 1431
    - Research Site
  - Sofia, Bulgaria, 1606
    - Research Site
  - Sofia, Bulgaria, 1421
    - Research Site
  - Stara Zagora, Bulgaria, 6003
    - Research Site
  - Stara Zagora, Bulgaria, 6000
    - Research Site
  - Varna, Bulgaria, 9000
    - Research Site
  - Veliko Tarnovo, Bulgaria, 5000
    - Research Site
  - Vidin, Bulgaria, 3700
    - Research Site
  - Vratsa, Bulgaria, 3000
    - Research Site
Canada
- Alberta
  - Edmonton, Alberta, Canada, T5A 4L8
    - Research Site
  - Sherwood Park, Alberta, Canada, T8H 2M7
    - Research Site
- British Columbia
  - Kelowna, British Columbia, Canada, V1Y 4N7
    - Research Site
  - Vancouver, British Columbia, Canada, V5Z 1M9
    - Research Site
  - Vancouver, British Columbia, Canada, V6Z 1Y6
    - Research Site
- Manitoba
  - Winnipeg, Manitoba, Canada, R2V 4W3
    - Research Site
  - Winnipeg, Manitoba, Canada, R3L 1Z5
    - Research Site
- Ontario
  - Ajax, Ontario, Canada, L1S 2J5
    - Research Site
  - Burlington, Ontario, Canada, L7N 3V2
    - Research Site
  - Hamilton, Ontario, Canada, L8S 1G5
    - Research Site
  - London, Ontario, Canada, N6A 1V2
    - Research Site
  - Newmarket, Ontario, Canada, L3Y 5G8
    - Research Site
  - Niagara Falls, Ontario, Canada, L2H 1H5
    - Research Site
  - Toronto, Ontario, Canada, M9V 4B4
    - Research Site
  - Toronto, Ontario, Canada, M5G 1E2
    - Research Site
- Quebec
  - Québec, Quebec, Canada, G1G 3Y8
    - Research Site
  - Québec, Quebec, Canada, G2J 0C4
    - Research Site
  - Québec, Quebec, Canada, G1V 4W2
    - Research Site
Chile
- - Chile, Chile, 7770484
    - Research Site
  - Curicó, Chile, 3341643
    - Research Site
  - Quillota, Chile, 2260000
    - Research Site
  - Santiago, Chile, 7500698
    - Research Site
  - Santiago, Chile, 8207257
    - Research Site
  - Santiago, Chile, 7500571
    - Research Site
  - Talca, Chile, 3481349
    - Research Site
Hungary
- - Balassagyarmat, Hungary, 2660
    - Research Site
  - Budapest, Hungary, 1204
    - Research Site
  - Edelény, Hungary, 3780
    - Research Site
  - Encs, Hungary, 3860
    - Research Site
  - Gödöllő, Hungary, 2100
    - Research Site
  - Hajdúnánás, Hungary, 4080
    - Research Site
  - Komárom, Hungary, 2900
    - Research Site
  - Pécs, Hungary, 7635
    - Research Site
  - Szeged, Hungary, 6720
    - Research Site
  - Szeged, Hungary, 6722
    - Research Site
  - Szigetvár, Hungary, 7900
    - Research Site
India
- - Ahmedabad, India, 382415
    - Research Site
  - Aligarh, India, 202002
    - Research Site
  - Belagavi, India, 590010
    - Research Site
  - Coimbatore, India, 641028
    - Research Site
  - Dehradun, India, 248001
    - Research Site
  - Gurgaon, India, 122001
    - Research Site
  - Jaipur, India, 302039
    - Research Site
  - Mohali, India, 160062
    - Research Site
  - Nagpur, India, 440012
    - Research Site
  - New Delhi, India, 110060
    - Research Site
  - New Delhi, India, 110075
    - Research Site
  - New Delhi, India, 110029
    - Research Site
  - Thane, India, 401107
    - Research Site
  - Visakhapatnam, India, 530002
    - Research Site
Italy
- - Bari, Italy, 70124
    - Research Site
  - Casatenovo, Italy, 23880
    - Research Site
  - Cona, Italy, 44124
    - Research Site
  - Monserrato, Italy, 09042
    - Research Site
  - Naples, Italy, 80131
    - Research Site
  - Pisa, Italy, 56100
    - Research Site
  - Roma, Italy, 00168
    - Research Site
  - Roma, Italy, 00133
    - Research Site
Japan
- - Chino-shi, Japan, 391-0011
    - Research Site
  - Chūōku, Japan, 103-0027
    - Research Site
  - Chūōku, Japan, 104-0031
    - Research Site
  - Chūōku, Japan, 103-0022
    - Research Site
  - Fukui-shi, Japan, 910-8526
    - Research Site
  - Fukuoka, Japan, 819-8555
    - Research Site
  - Fukuoka, Japan, 811-1394
    - Research Site
  - Habikino-shi, Japan, 583-8588
    - Research Site
  - Hamamatsu, Japan, 431-3192
    - Research Site
  - Higashiibaraki-gun, Japan, 311-3117
    - Research Site
  - Himeji-shi, Japan, 672-8064
    - Research Site
  - Hiroshima-shi, Naka-ku, Japan, 730-0853
    - Research Site
  - Hitachi-Naka, Japan, 312-0057
    - Research Site
  - Ikoma-shi, Japan, 630-0293
    - Research Site
  - Kishiwada-shi, Japan, 596-8501
    - Research Site
  - Kitakyushu, Japan, 802-0052
    - Research Site
  - Kiyose-shi, Japan, 204-8585
    - Research Site
  - Kokubunji-shi, Japan, 185-0014
    - Research Site
  - Kyoto, Japan, 612-8555
    - Research Site
  - Kyoto, Japan, 601-8213
    - Research Site
  - Meguro-ku, Japan, 153-0051
    - Research Site
  - Nagoya, Japan, 457-0866
    - Research Site
  - Nankoku-shi, Japan, 783-8509
    - Research Site
  - Obihiro, Japan, 080-0017
    - Research Site
  - Omuta-shi, Japan, 837-0911
    - Research Site
  - Osaka, Japan, 530-0001
    - Research Site
  - Osaka, Japan, 531-0073
    - Research Site
  - Osaka, Japan, 551-0032
    - Research Site
  - Saga, Japan, 849-0917
    - Research Site
  - Sakaide-shi, Japan, 762-8550
    - Research Site
  - Sapporo, Japan, 064-0804
    - Research Site
  - Setagaya-ku, Japan, 157-0072
    - Research Site
  - Setagaya-ku, Japan, 158-0097
    - Research Site
  - Shibuya-ku, Japan, 150-0013
    - Research Site
  - Shimotsuga-gun, Japan, 321-0293
    - Research Site
  - Shinagawa-ku, Japan, 140-8522
    - Research Site
  - Shinagawa-ku, Japan, 140-0001
    - Research Site
  - Shinjuku-ku, Japan, 160-8582
    - Research Site
  - Shinjuku-ku, Japan, 160-0004
    - Research Site
  - Takarazuka-shi, Japan, 665-0827
    - Research Site
  - Tanabe-shi, Japan, 646-8558
    - Research Site
  - Toon-shi, Japan, 791-0281
    - Research Site
  - Toshima-ku, Japan, 170-0003
    - Research Site
  - Toshima-ku, Japan, 171-0014
    - Research Site
  - Toshima-ku, Japan, 170-0002
    - Research Site
  - Tsuchiura-shi, Japan, 300-8585
    - Research Site
  - Utsunomiya, Japan, 329-1193
    - Research Site
  - Yanagawa-shi, Japan, 832-0059
    - Research Site
  - Yokohama, Japan, 232-0024
    - Research Site
  - Yokohama, Japan, 240-8555
    - Research Site
  - Yokohama, Japan, 223-0059
    - Research Site
  - Yokohama, Japan, 231-8682
    - Research Site
  - Ōita, Japan, 870-8511
    - Research Site
New Zealand
- - Auckland, New Zealand, 0626
    - Research Site
  - Grafton, New Zealand, 1010
    - Research Site
  - Nawton, New Zealand, 3200
    - Research Site
  - Nelson, New Zealand, 7011
    - Research Site
  - Rotorua, New Zealand, 3040
    - Research Site
  - Wellington, New Zealand, 6021
    - Research Site
Peru
- - Lima, Peru, LIMA 31
    - Research Site
  - Lima, Peru, 15046
    - Research Site
  - Lima, Peru, 15036
    - Research Site
  - Lima, Peru, 15088
    - Research Site
  - Lima, Peru, LIMA 21
    - Research Site
  - Lima, Peru, 15131
    - Research Site
  - Piura, Peru, 20001
    - Research Site
Philippines
- - Baguio City, Philippines, 2600
    - Research Site
  - Davao City, Philippines, PH-8000
    - Research Site
  - Iloilo City, Philippines, 5000
    - Research Site
  - Las Piñas, Philippines, 1742
    - Research Site
  - Lipa City, Philippines, 4217
    - Research Site
  - Los Baños, Philippines, 4030
    - Research Site
  - Manila, Philippines, 1000
    - Research Site
  - Manila, Philippines, 1014
    - Research Site
  - Marilao, Philippines, 3019
    - Research Site
  - Quezon City, Philippines
    - Research Site
  - Quezon City, Philippines, 1101
    - Research Site
Poland
- - Bialystok, Poland, 15-044
    - Research Site
  - Bialystok, Poland, 15-430
    - Research Site
  - Bydgoszcz, Poland, 85-079
    - Research Site
  - Częstochowa, Poland, 42-217
    - Research Site
  - Karczew, Poland, 05-480
    - Research Site
  - Katowice, Poland, 40-648
    - Research Site
  - Kielce, Poland, 25-734
    - Research Site
  - Krakow, Poland, 31-011
    - Research Site
  - Krakow, Poland, 30-727
    - Research Site
  - Krakow, Poland, 31-141
    - Research Site
  - Piaseczno, Poland, 05-500
    - Research Site
  - Poznan, Poland, 60-693
    - Research Site
  - Poznan, Poland, 61-578
    - Research Site
  - Poznan, Poland, 60-214
    - Research Site
  - Rzeszów, Poland, 35-051
    - Research Site
  - Rzeszów, Poland, 35-205
    - Research Site
  - Rzeszów, Poland, 35-055
    - Research Site
  - Sosnowiec, Poland, 41-200
    - Research Site
  - Sosnowiec, Poland, 41-208
    - Research Site
  - Strzelce Opolskie, Poland, 47-100
    - Research Site
  - Szczecin, Poland, 70-111
    - Research Site
  - Tarnów, Poland, 33-100
    - Research Site
  - Wroclaw, Poland, 54-239
    - Research Site
  - Wroclaw, Poland, 53-301
    - Research Site
Puerto Rico
- - Caguas, Puerto Rico, 00726
    - Research Site
  - Guaynabo, Puerto Rico, 00968
    - Research Site
  - San Juan, Puerto Rico, 00918
    - Research Site
Romania
- - Brasov, Romania, 500283
    - Research Site
  - Brasov, Romania, 500051
    - Research Site
  - Brasov, Romania, 500366
    - Research Site
  - Bucharest, Romania, 050159
    - Research Site
  - Timișoara, Romania, 300002
    - Research Site
South Korea
- - Cheongju-si, South Korea, 28644
    - Research Site
  - Gangwon-do, South Korea, 26426
    - Research Site
  - Jeonju, South Korea, 54907
    - Research Site
  - Seoul, South Korea, 03722
    - Research Site
  - Seoul, South Korea, 05505
    - Research Site
  - Seoul, South Korea, 06591
    - Research Site
  - Seoul, South Korea, 03312
    - Research Site
  - Suwon, South Korea, 16499
    - Research Site
  - Uijeongbu-si, South Korea, 11765
    - Research Site
  - Ulsan, South Korea, 44033
    - Research Site
Spain
- - Barcelona, Spain, 08017
    - Research Site
  - Benalmádena, Spain, 29631
    - Research Site
  - Coslada, Spain, 28822
    - Research Site
  - L'Hospitalet de Llobregat, Spain, 08907
    - Research Site
  - Madrid, Spain, 28031
    - Research Site
  - Madrid, Spain, 28007
    - Research Site
  - Marbella (Málaga), Spain, 29603
    - Research Site
  - Málaga, Spain, 29010
    - Research Site
  - Pozuelo de Alarcón, Spain, 28223
    - Research Site
  - Santander, Spain, 39008
    - Research Site
  - Valencia, Spain, 46026
    - Research Site
  - Zaragoza, Spain, 50009
    - Research Site
  - Zaragoza, Spain, 50015
    - Research Site
Taiwan
- - Changhua, Taiwan, 50006
    - Research Site
  - Kaohsiung City, Taiwan, 80756
    - Research Site
  - Kaohsiung City, Taiwan, 833
    - Research Site
  - New Taipei City, Taiwan, 23561
    - Research Site
  - Taichung, Taiwan, 40705
    - Research Site
  - Taichung, Taiwan, 40447
    - Research Site
  - Tainan, Taiwan, 704
    - Research Site
  - Taipei, Taiwan, 10449
    - Research Site
  - Taipei, Taiwan, 110
    - Research Site
  - Taoyuan, Taiwan
    - Research Site
Thailand
- - Bang Kra So, Thailand, 11000
    - Research Site
  - Bangkok, Thailand, 10330
    - Research Site
  - Bangkok, Thailand, 10400
    - Research Site
  - Bangkok, Thailand, 10700
    - Research Site
  - Chanthaburi, Thailand, 22000
    - Research Site
  - Hat Yai, Thailand, 90110
    - Research Site
  - Khon Kaen, Thailand, 40002
    - Research Site
  - Muang, Thailand, 55000
    - Research Site
  - Mueang, Thailand, 20000
    - Research Site
United States
- Alabama
  - Saraland, Alabama, United States, 36571
    - Research Site
- Arizona
  - Phoenix, Arizona, United States, 85018
    - Research Site
  - Phoenix, Arizona, United States, 85027
    - Research Site
  - Sun City West, Arizona, United States, 85375
    - Research Site
  - Tucson, Arizona, United States, 85715
    - Research Site
  - Tucson, Arizona, United States, 85745
    - Research Site
- Arkansas
  - Little Rock, Arkansas, United States, 72209
    - Research Site
- California
  - Covina, California, United States, 91723
    - Research Site
  - Encinitas, California, United States, 92024
    - Research Site
  - Fresno, California, United States, 93701
    - Research Site
  - Laguna Hills, California, United States, 92653
    - Research Site
  - Long Beach, California, United States, 90806
    - Research Site
  - Los Angeles, California, United States, 90027
    - Research Site
  - Los Angeles, California, United States, 90017
    - Research Site
  - Mission Hills, California, United States, 91345
    - Research Site
  - Newport Beach, California, United States, 92663
    - Research Site
  - Northridge, California, United States, 91324
    - Research Site
  - San Diego, California, United States, 92119
    - Research Site
  - Stockton, California, United States, 95207
    - Research Site
  - Thousand Oaks, California, United States, 91360
    - Research Site
  - Upland, California, United States, 91786
    - Research Site
  - Westminster, California, United States, 92683
    - Research Site
- Colorado
  - Colorado Springs, Colorado, United States, 80923
    - Research Site
  - Lakewood, Colorado, United States, 80228
    - Research Site
- Florida
  - Brandon, Florida, United States, 33511
    - Research Site
  - Miami, Florida, United States, 33175
    - Research Site
  - Tampa, Florida, United States, 33607
    - Research Site
- Georgia
  - Adairsville, Georgia, United States, 30103
    - Research Site
  - Atlanta, Georgia, United States, 30344
    - Research Site
  - Columbus, Georgia, United States, 31904
    - Research Site
  - Lawrenceville, Georgia, United States, 30046
    - Research Site
  - Rincon, Georgia, United States, 31326
    - Research Site
  - Savannah, Georgia, United States, 31406
    - Research Site
  - Tyrone, Georgia, United States, 30290
    - Research Site
- Illinois
  - Chicago, Illinois, United States, 60657
    - Research Site
  - River Forest, Illinois, United States, 60305
    - Research Site
- Indiana
  - Brownsburg, Indiana, United States, 46112
    - Research Site
  - Indianapolis, Indiana, United States, 46202
    - Research Site
- Kentucky
  - Louisville, Kentucky, United States, 40217
    - Research Site
- Louisiana
  - Crowley, Louisiana, United States, 70526
    - Research Site
  - Lafayette, Louisiana, United States, 70508
    - Research Site
  - Lake Charles, Louisiana, United States, 70601
    - Research Site
- Maine
  - Bangor, Maine, United States, 04401
    - Research Site
- Maryland
  - Potomac, Maryland, United States, 20854
    - Research Site
  - Waldorf, Maryland, United States, 20601
    - Research Site
- Massachusetts
  - Boston, Massachusetts, United States, 02115
    - Research Site
- Missouri
  - Hannibal, Missouri, United States, 63401
    - Research Site
  - St Louis, Missouri, United States, 63141
    - Research Site
- Montana
  - Missoula, Montana, United States, 59808
    - Research Site
- Nebraska
  - Bellevue, Nebraska, United States, 68123
    - Research Site
  - Lincoln, Nebraska, United States, 68510
    - Research Site
- Nevada
  - Las Vegas, Nevada, United States, 89106
    - Research Site
- New Jersey
  - Toms River, New Jersey, United States, 08755
    - Research Site
- New Mexico
  - Albuquerque, New Mexico, United States, 87108
    - Research Site
- New York
  - New Hyde Park, New York, United States, 11042
    - Research Site
  - New Windsor, New York, United States, 12553
    - Research Site
  - New York, New York, United States, 10016
    - Research Site
  - The Bronx, New York, United States, 10455
    - Research Site
- North Carolina
  - Charlotte, North Carolina, United States, 28277
    - Research Site
  - Denver, North Carolina, United States, 28037
    - Research Site
  - Gastonia, North Carolina, United States, 28054
    - Research Site
  - Raleigh, North Carolina, United States, 27607
    - Research Site
- North Dakota
  - Fargo, North Dakota, United States, 58104
    - Research Site
- Ohio
  - Cincinnati, Ohio, United States, 45231
    - Research Site
  - Cincinnati, Ohio, United States, 45229
    - Research Site
  - Maumee, Ohio, United States, 43537
    - Research Site
  - Toledo, Ohio, United States, 43617
    - Research Site
- Oklahoma
  - Edmond, Oklahoma, United States, 73034
    - Research Site
  - Oklahoma City, Oklahoma, United States, 73120
    - Research Site
  - Tulsa, Oklahoma, United States, 74133
    - Research Site
- Oregon
  - Grants Pass, Oregon, United States, 97527
    - Research Site
- Pennsylvania
  - DuBois, Pennsylvania, United States, 15801
    - Research Site
  - Pittsburgh, Pennsylvania, United States, 15241
    - Research Site
  - Pittsburgh, Pennsylvania, United States, 15236
    - Research Site
  - Scottdale, Pennsylvania, United States, 15683
    - Research Site
  - Smithfield, Pennsylvania, United States, 15478
    - Research Site
- Rhode Island
  - East Providence, Rhode Island, United States, 02914
    - Research Site
- South Carolina
  - Anderson, South Carolina, United States, 29621
    - Research Site
  - Greenville, South Carolina, United States, 29607
    - Research Site
  - North Charleston, South Carolina, United States, 29406
    - Research Site
- Tennessee
  - Franklin, Tennessee, United States, 37067
    - Research Site
- Texas
  - Amarillo, Texas, United States, 79106
    - Research Site
  - Austin, Texas, United States, 78759
    - Research Site
  - Boerne, Texas, United States, 78006
    - Research Site
  - Cypress, Texas, United States, 77429
    - Research Site
  - Dallas, Texas, United States, 75231
    - Research Site
  - El Paso, Texas, United States, 79912
    - Research Site
  - Harlingen, Texas, United States, 78550
    - Research Site
  - Houston, Texas, United States, 77030
    - Research Site
  - Houston, Texas, United States, 77021
    - Research Site
  - Kerrville, Texas, United States, 78028
    - Research Site
  - Lampasas, Texas, United States, 76550
    - Research Site
  - Nederland, Texas, United States, 77627
    - Research Site
  - Pearland, Texas, United States, 77584
    - Research Site
  - Red Oak, Texas, United States, 75154
    - Research Site
  - San Antonio, Texas, United States, 78229
    - Research Site
  - San Antonio, Texas, United States, 78215
    - Research Site
  - San Antonio, Texas, United States, 78258
    - Research Site
  - Spring, Texas, United States, 77386
    - Research Site
  - Tomball, Texas, United States, 77375
    - Research Site
- Utah
  - Ogden, Utah, United States, 84404
    - Research Site
  - West Valley City, Utah, United States, 84120
    - Research Site
- Vermont
  - Colchester, Vermont, United States, 05446
    - Research Site
- Virginia
  - Manassas, Virginia, United States, 20110
    - Research Site
- West Virginia
  - Kingwood, West Virginia, United States, 26537
    - Research Site
  - Morgantown, West Virginia, United States, 26505
    - Research Site
- Wisconsin
  - Cudahy, Wisconsin, United States, 53110
    - Research Site
Vietnam
- - Hanoi, Vietnam, 100000
    - Research Site
  - Ho Chi Minh City, Vietnam, 700000
    - Research Site
  - Ho Chi Minh City, Vietnam, 70000
    - Research Site
  - Hochiminh, Vietnam, 700000
    - Research Site
  - Hà Nội, Vietnam, 100000
    - 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 ≥ 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 half-lives 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 Chronic Obstructive Pulmonary Disease (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 Long-Acting Muscarinic Antagonist (LAMA), either alone or as part of an inhaled combination therapy, in the 12 weeks prior to V1.

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 FEV1 AUC0-3 (L) at Week 24 Time Frame: 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 (KALOS/LOGOS): Rate of Severe Asthma Exacerbations Time Frame: Up to 52 weeks	Rate of severe asthma exacerbations was assessed in a pre-specified pooled analysis across replicate studies D5982C00007 and D5982C00008 (NCT04609904). An asthma exacerbation was severe if it resulted in at least 1 of the following: a course of systemic corticosteroids for 3 days to treat symptoms of asthma worsening, an ER/urgent care visit that required treatment with systemic corticosteroids, an inpatient hospitalization, or death related to asthma. Consecutive exacerbations with start/stop days ≤7 days apart were considered the same event of the highest severity. 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
Change From Baseline in Morning Pre-dose Trough FEV1 (L) at Week 24 Time Frame: Week 24	Change from baseline in morning pre-dose trough forced expiratory volume in 1 second (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 Time Frame: Day 1	Onset of action on Day 1: Absolute change in FEV1 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 Time Frame: Week 24	Percentage of responders in the 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 the ACQ-5 (≥0.5 Decrease Equals Response) at Week 24 Time Frame: 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 Time Frame: 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
Percentage of Responders in SGRQ (≥4.0 Decrease Equals Response) at Week 24 Time Frame: 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
Pooled (KALOS/LOGOS): Rate of Severe Asthma Exacerbations for Participants With Percent Predicted FEV1 ≤55% at Baseline Time Frame: Up to 52 weeks	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 D5982C00007 and D5982C00008 (NCT04609904). An asthma exacerbation was severe if it resulted in at least 1 of the following: a course of systemic corticosteroids for 3 days to treat symptoms of asthma worsening, an ER/urgent care visit that required treatment with systemic corticosteroids, an inpatient hospitalization , or death related to asthma. Consecutive exacerbations with start/stop days ≤7 days apart were considered the same event of the highest severity. 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 (KALOS/LOGOS): 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	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 D5982C00007 and D5982C00008 (NCT04609904). An asthma exacerbation was considered severe if it resulted in at least 1 of the following: a course of systemic corticosteroids for 3 days to treat symptoms of asthma worsening, an ER/urgent care visit that required treatment with systemic corticosteroids, an inpatient hospitalization, or death related to asthma. Consecutive exacerbations with start/stop days ≤7 days apart were considered the same event of the highest severity. 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 (KALOS/LOGOS): Time to First Severe Asthma Exacerbation Time Frame: Up to 52 weeks	Time to first severe asthma exacerbation was assessed in a pre-specified pooled analysis across replicate studies D5982C00007 and D5982C00008 (NCT04609904). 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 (KALOS/LOGOS): Rate of Moderate or Severe Asthma Exacerbations Time Frame: Up to 52 weeks	Rate of moderate or severe asthma exacerbations was assessed in a pre-specified pooled analysis across replicate studies D5982C00007 and D5982C00008 (NCT04609904). An asthma exacerbation was severe if it resulted in at least 1 of the following: a course of systemic corticosteroids for 3 days to treat symptoms of asthma worsening, an ER/urgent care visit that required systemic corticosteroids, an inpatient hospitalization, or death related to asthma. A moderate asthma exacerbation was a worsening of symptoms that resulted in an additional ICS for 3 days. Consecutive exacerbations with start/stop days ≤7 days apart were considered the same event of the highest severity. 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 (KALOS/LOGOS): Time to First Moderate or Severe Asthma Exacerbation Time Frame: Up to 52 weeks	Time to first moderate/severe asthma exacerbation was assessed in a pre-specified pooled analysis across replicate studies D5982C00007 and D5982C00008 (NCT04609904). 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 or 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 (KALOS/LOGOS): Percentage of Responders in ACQ-7 (≥0.5 Decrease Equals Response) at Week 24 Time Frame: Week 24	Pooled 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 D5982C00007 and D5982C00008 (NCT04609904). 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 (KALOS/LOGOS): Percentage of Responders in ACQ-5 (≥0.5 Decrease Equals Response) at Week 24 Time Frame: Week 24	Pooled 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 D5982C00007 and D5982C00008 (NCT04609904). 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 (KALOS/LOGOS): Percentage of Responders in AQLQ(s)+12 (≥0.5 Increase Equals Response) at Week 24 Time Frame: Week 24	Pooled 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 D5982C00007 and D5982C00008 (NCT04609904). 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

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

Sponsor

AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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)

December 15, 2020

Primary Completion (Actual)

March 21, 2025

Study Completion (Actual)

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)

June 30, 2026

Last Update Submitted That Met QC Criteria

June 23, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

D5982C00007
2020-001520-34 (EudraCT Number)
2023-505787-11 (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

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 Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

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

Publications and helpful links

General Publications

Helpful Links

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Actual)

Study Completion (Actual)

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

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