AsthmaPhase 3KALOSNCT04609878
Study to Assess PT010 in Adult and Adolescent Participants With Inadequately Controlled Asthma (KALOS)
A Phase 3 study testing BGF MDI 320/28.8/9.6 μg, BGF MDI 320/14.4/9.6 μg and BFF MDI 320/9.6 μg in people with Asthma, run by AstraZeneca at 360 sites in 21 countries.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 12 to 80 years
- Conditions the study is for
- Asthma
- What is being tested?
- BGF MDI 320/28.8/9.6 μg, BGF MDI 320/14.4/9.6 μg and BFF MDI 320/9.6 μg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,274 participants
- Where
- 360 sitesin 21 countries
- Study dates
- 15 Dec 2020to 21 Mar 2025
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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%
Show all 16Show fewer
- 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.
Who cannot join
- 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.
Show all 22Show fewer
- 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.
Trial locations and contacts
360 sites in 21 countries.
360 sites in 21 countries
United States107 sites
Research Site
Adairsville, Georgia, 30103
Research Site
Albuquerque, New Mexico, 87108
Research Site
Amarillo, Texas, 79106
Research Site
Anderson, South Carolina, 29621
Research Site
Atlanta, Georgia, 30344
Research Site
Austin, Texas, 78759
Research Site
Bangor, Maine, 04401
Research Site
Bellevue, Nebraska, 68123
Research Site
Boerne, Texas, 78006
Research Site
Boston, Massachusetts, 02115
Research Site
Brandon, Florida, 33511
Research Site
Brownsburg, Indiana, 46112
Research Site
Charlotte, North Carolina, 28277
Research Site
Chicago, Illinois, 60657
Research Site
Cincinnati, Ohio, 45229
Research Site
Cincinnati, Ohio, 45231
Research Site
Colchester, Vermont, 05446
Research Site
Colorado Springs, Colorado, 80923
Research Site
Columbus, Georgia, 31904
Research Site
Covina, California, 91723
Research Site
Crowley, Louisiana, 70526
Research Site
Cudahy, Wisconsin, 53110
Research Site
Cypress, Texas, 77429
Research Site
Dallas, Texas, 75231
Research Site
Denver, North Carolina, 28037
Research Site
DuBois, Pennsylvania, 15801
Research Site
East Providence, Rhode Island, 02914
Research Site
Edmond, Oklahoma, 73034
Research Site
El Paso, Texas, 79912
Research Site
Encinitas, California, 92024
Research Site
Fargo, North Dakota, 58104
Research Site
Franklin, Tennessee, 37067
Research Site
Fresno, California, 93701
Research Site
Gastonia, North Carolina, 28054
Research Site
Grants Pass, Oregon, 97527
Research Site
Greenville, South Carolina, 29607
Research Site
Hannibal, Missouri, 63401
Research Site
Harlingen, Texas, 78550
Research Site
Houston, Texas, 77021
Research Site
Houston, Texas, 77030
Research Site
Indianapolis, Indiana, 46202
Research Site
Kerrville, Texas, 78028
Research Site
Kingwood, West Virginia, 26537
Research Site
Lafayette, Louisiana, 70508
Research Site
Laguna Hills, California, 92653
Research Site
Lake Charles, Louisiana, 70601
Research Site
Lakewood, Colorado, 80228
Research Site
Lampasas, Texas, 76550
Research Site
Las Vegas, Nevada, 89106
Research Site
Lawrenceville, Georgia, 30046
Research Site
Lincoln, Nebraska, 68510
Research Site
Little Rock, Arkansas, 72209
Research Site
Long Beach, California, 90806
Research Site
Los Angeles, California, 90017
Research Site
Los Angeles, California, 90027
Research Site
Louisville, Kentucky, 40217
Research Site
Manassas, Virginia, 20110
Research Site
Maumee, Ohio, 43537
Research Site
Miami, Florida, 33175
Research Site
Mission Hills, California, 91345
Research Site
Missoula, Montana, 59808
Research Site
Morgantown, West Virginia, 26505
Research Site
Nederland, Texas, 77627
Research Site
New Hyde Park, New York, 11042
Research Site
New Windsor, New York, 12553
Research Site
New York, New York, 10016
Research Site
Newport Beach, California, 92663
Research Site
North Charleston, South Carolina, 29406
Research Site
Northridge, California, 91324
Research Site
Ogden, Utah, 84404
Research Site
Oklahoma City, Oklahoma, 73120
Research Site
Pearland, Texas, 77584
Research Site
Phoenix, Arizona, 85018
Research Site
Phoenix, Arizona, 85027
Research Site
Pittsburgh, Pennsylvania, 15236
Research Site
Pittsburgh, Pennsylvania, 15241
Research Site
Potomac, Maryland, 20854
Research Site
Raleigh, North Carolina, 27607
Research Site
Red Oak, Texas, 75154
Research Site
Rincon, Georgia, 31326
Research Site
River Forest, Illinois, 60305
Research Site
San Antonio, Texas, 78215
Research Site
San Antonio, Texas, 78229
Research Site
San Antonio, Texas, 78258
Research Site
San Diego, California, 92119
Research Site
Saraland, Alabama, 36571
Research Site
Savannah, Georgia, 31406
Research Site
Scottdale, Pennsylvania, 15683
Research Site
Smithfield, Pennsylvania, 15478
Research Site
Spring, Texas, 77386
Research Site
St Louis, Missouri, 63141
Research Site
Stockton, California, 95207
Research Site
Sun City West, Arizona, 85375
Research Site
Tampa, Florida, 33607
Research Site
The Bronx, New York, 10455
Research Site
Thousand Oaks, California, 91360
Research Site
Toledo, Ohio, 43617
Research Site
Tomball, Texas, 77375
Research Site
Toms River, New Jersey, 08755
Research Site
Tucson, Arizona, 85715
Research Site
Tucson, Arizona, 85745
Research Site
Tulsa, Oklahoma, 74133
Research Site
Tyrone, Georgia, 30290
Research Site
Upland, California, 91786
Research Site
Waldorf, Maryland, 20601
Research Site
West Valley City, Utah, 84120
Research Site
Westminster, California, 92683
Japan53 sites
Research Site
Chino-shi, 391-0011
Research Site
Chūōku, 103-0022
Research Site
Chūōku, 103-0027
Research Site
Chūōku, 104-0031
Research Site
Fukui-shi, 910-8526
Research Site
Fukuoka, 811-1394
Research Site
Fukuoka, 819-8555
Research Site
Habikino-shi, 583-8588
Research Site
Hamamatsu, 431-3192
Research Site
Higashiibaraki-gun, 311-3117
Research Site
Himeji-shi, 672-8064
Research Site
Hiroshima-shi, Naka-ku, 730-0853
Research Site
Hitachi-Naka, 312-0057
Research Site
Ikoma-shi, 630-0293
Research Site
Kishiwada-shi, 596-8501
Research Site
Kitakyushu, 802-0052
Research Site
Kiyose-shi, 204-8585
Research Site
Kokubunji-shi, 185-0014
Research Site
Kyoto, 601-8213
Research Site
Kyoto, 612-8555
Research Site
Meguro-ku, 153-0051
Research Site
Nagoya, 457-0866
Research Site
Nankoku-shi, 783-8509
Research Site
Obihiro, 080-0017
Research Site
Ōita, 870-8511
Research Site
Omuta-shi, 837-0911
Research Site
Osaka, 530-0001
Research Site
Osaka, 531-0073
Research Site
Osaka, 551-0032
Research Site
Saga, 849-0917
Research Site
Sakaide-shi, 762-8550
Research Site
Sapporo, 064-0804
Research Site
Setagaya-ku, 157-0072
Research Site
Setagaya-ku, 158-0097
Research Site
Shibuya-ku, 150-0013
Research Site
Shimotsuga-gun, 321-0293
Research Site
Shinagawa-ku, 140-0001
Research Site
Shinagawa-ku, 140-8522
Research Site
Shinjuku-ku, 160-0004
Research Site
Shinjuku-ku, 160-8582
Research Site
Takarazuka-shi, 665-0827
Research Site
Tanabe-shi, 646-8558
Research Site
Toon-shi, 791-0281
Research Site
Toshima-ku, 170-0002
Research Site
Toshima-ku, 170-0003
Research Site
Toshima-ku, 171-0014
Research Site
Tsuchiura-shi, 300-8585
Research Site
Utsunomiya, 329-1193
Research Site
Yanagawa-shi, 832-0059
Research Site
Yokohama, 223-0059
Research Site
Yokohama, 231-8682
Research Site
Yokohama, 232-0024
Research Site
Yokohama, 240-8555
Poland24 sites
Research Site
Bialystok, 15-044
Research Site
Bialystok, 15-430
Research Site
Bydgoszcz, 85-079
Research Site
Częstochowa, 42-217
Research Site
Karczew, 05-480
Research Site
Katowice, 40-648
Research Site
Kielce, 25-734
Research Site
Krakow, 30-727
Research Site
Krakow, 31-011
Research Site
Krakow, 31-141
Research Site
Piaseczno, 05-500
Research Site
Poznan, 60-214
Research Site
Poznan, 60-693
Research Site
Poznan, 61-578
Research Site
Rzeszów, 35-051
Research Site
Rzeszów, 35-055
Research Site
Rzeszów, 35-205
Research Site
Sosnowiec, 41-200
Research Site
Sosnowiec, 41-208
Research Site
Strzelce Opolskie, 47-100
Research Site
Szczecin, 70-111
Research Site
Tarnów, 33-100
Research Site
Wroclaw, 53-301
Research Site
Wroclaw, 54-239
Bulgaria23 sites
Research Site
Dupnitsa, 2600
Research Site
Dupnitsa, 2602
Research Site
Haskovo, 6305
Research Site
Kozloduy, 3320
Research Site
Lovech, 5500
Research Site
Pazardzhik, 4400
Research Site
Petrich, 2850
Research Site
Pleven, 5800
Research Site
Rousse, 7000
Research Site
Rousse, 7002
Research Site
Sevlievo, 5403
Research Site
Sliven, 8800
Research Site
Smolyan, 3700
Research Site
Sofia, 1000
Research Site
Sofia, 1421
Research Site
Sofia, 1431
Research Site
Sofia, 1606
Research Site
Stara Zagora, 6000
Research Site
Stara Zagora, 6003
Research Site
Varna, 9000
Research Site
Veliko Tarnovo, 5000
Research Site
Vidin, 3700
Research Site
Vratsa, 3000
Canada18 sites
Research Site
Ajax, Ontario, L1S 2J5
Research Site
Burlington, Ontario, L7N 3V2
Research Site
Edmonton, Alberta, T5A 4L8
Research Site
Hamilton, Ontario, L8S 1G5
Research Site
Kelowna, British Columbia, V1Y 4N7
Research Site
London, Ontario, N6A 1V2
Research Site
Newmarket, Ontario, L3Y 5G8
Research Site
Niagara Falls, Ontario, L2H 1H5
Research Site
Québec, Quebec, G1G 3Y8
Research Site
Québec, Quebec, G1V 4W2
Research Site
Québec, Quebec, G2J 0C4
Research Site
Sherwood Park, Alberta, T8H 2M7
Research Site
Toronto, Ontario, M5G 1E2
Research Site
Toronto, Ontario, M9V 4B4
Research Site
Vancouver, British Columbia, V5Z 1M9
Research Site
Vancouver, British Columbia, V6Z 1Y6
Research Site
Winnipeg, Manitoba, R2V 4W3
Research Site
Winnipeg, Manitoba, R3L 1Z5
Argentina14 sites
Research Site
Buenos Aires, C1121ABE
Research Site
CABA, 1056
Research Site
CABA, C1425BEN
Research Site
Ciudad de Buenos Aires, 1425
Research Site
Ciudad de Buenos Aires, C1280AEB
Research Site
Ciudad de Buenos Aires, C1414AIF
Research Site
Córdoba, X5003DCE
Research Site
Florida, B1602DQD
Research Site
Mar del Plata, 7600
Research Site
Mendoza, M5500CCG
Research Site
Ranelagh, 1886
Research Site
Rosario, 2000
Research Site
Rosario, S2000DEJ
Research Site
San Fernando, B1646EBJ
India14 sites
Research Site
Ahmedabad, 382415
Research Site
Aligarh, 202002
Research Site
Belagavi, 590010
Research Site
Coimbatore, 641028
Research Site
Dehradun, 248001
Research Site
Gūrgaon, 122001
Research Site
Jaipur, 302039
Research Site
Mohali, 160062
Research Site
Nagpur, 440012
Research Site
New Delhi, 110029
Research Site
New Delhi, 110060
Research Site
New Delhi, 110075
Research Site
Thane, 401107
Research Site
Visakhapatnam, 530002
Spain13 sites
Research Site
Barcelona, 08017
Research Site
Benalmádena, 29631
Research Site
Coslada, 28822
Research Site
L'Hospitalet de Llobregat, 08907
Research Site
Madrid, 28007
Research Site
Madrid, 28031
Research Site
Málaga, 29010
Research Site
Marbella (Málaga), 29603
Research Site
Pozuelo de Alarcón, 28223
Research Site
Santander, 39008
Research Site
Valencia, 46026
Research Site
Zaragoza, 50009
Research Site
Zaragoza, 50015
Hungary11 sites
Research Site
Balassagyarmat, 2660
Research Site
Budapest, 1204
Research Site
Edelény, 3780
Research Site
Encs, 3860
Research Site
Gödöllő, 2100
Research Site
Hajdúnánás, 4080
Research Site
Komárom, 2900
Research Site
Pécs, 7635
Research Site
Szeged, 6720
Research Site
Szeged, 6722
Research Site
Szigetvár, 7900
Philippines11 sites
Research Site
Baguio City, 2600
Research Site
Davao City, PH-8000
Research Site
Iloilo City, 5000
Research Site
Las Piñas, 1742
Research Site
Lipa City, 4217
Research Site
Los Baños, 4030
Research Site
Manila, 1000
Research Site
Manila, 1014
Research Site
Marilao, 3019
Research Site
Quezon City, 1101
Research Site
Quezon City
South Korea10 sites
Research Site
Cheongju-si, 28644
Research Site
Gangwon-do, 26426
Research Site
Jeonju, 54907
Research Site
Seoul, 03312
Research Site
Seoul, 03722
Research Site
Seoul, 05505
Research Site
Seoul, 06591
Research Site
Suwon, 16499
Research Site
Uijeongbu-si, 11765
Research Site
Ulsan, 44033
Taiwan10 sites
Research Site
Changhua, 50006
Research Site
Kaohsiung City, 80756
Research Site
Kaohsiung City, 833
Research Site
New Taipei City, 23561
Research Site
Taichung, 40447
Research Site
Taichung, 40705
Research Site
Tainan, 704
Research Site
Taipei, 10449
Research Site
Taipei, 110
Research Site
Taoyuan
Thailand9 sites
Research Site
Bang Kra So, 11000
Research Site
Bangkok, 10330
Research Site
Bangkok, 10400
Research Site
Bangkok, 10700
Research Site
Chanthaburi, 22000
Research Site
Hat Yai, 90110
Research Site
Khon Kaen, 40002
Research Site
Muang, 55000
Research Site
Mueang, 20000
Italy8 sites
Research Site
Bari, 70124
Research Site
Casatenovo, 23880
Research Site
Cona, 44124
Research Site
Monserrato, 09042
Research Site
Naples, 80131
Research Site
Pisa, 56100
Research Site
Roma, 00133
Research Site
Roma, 00168
Chile7 sites
Research Site
Chile, 7770484
Research Site
Curicó, 3341643
Research Site
Quillota, 2260000
Research Site
Santiago, 7500571
Research Site
Santiago, 7500698
Research Site
Santiago, 8207257
Research Site
Talca, 3481349
Peru7 sites
Research Site
Lima, 15036
Research Site
Lima, 15046
Research Site
Lima, 15088
Research Site
Lima, 15131
Research Site
Lima, LIMA 21
Research Site
Lima, LIMA 31
Research Site
Piura, 20001
New Zealand6 sites
Research Site
Auckland, 0626
Research Site
Grafton, 1010
Research Site
Nawton, 3200
Research Site
Nelson, 7011
Research Site
Rotorua, 3040
Research Site
Wellington, 6021
Romania5 sites
Research Site
Brasov, 500051
Research Site
Brasov, 500283
Research Site
Brasov, 500366
Research Site
Bucharest, 050159
Research Site
Timișoara, 300002
Vietnam5 sites
Research Site
Hà Nội, 100000
Research Site
Hanoi, 100000
Research Site
Ho Chi Minh City, 700000
Research Site
Ho Chi Minh City, 70000
Research Site
Hochiminh, 700000
Puerto Rico3 sites
Research Site
Caguas, 00726
Research Site
Guaynabo, 00968
Research Site
San Juan, 00918
About this study
Official title: 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
Read the 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.
- Conditions
- Asthma
- Being tested
- BGF MDI 320/28.8/9.6 μg, BGF MDI 320/14.4/9.6 μg, BFF MDI 320/9.6 μg, BFF pMDI 320/9 μg
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BGF MDI 320/28.8/9.6 μgDrug
Also called BGF
Budesonide, glycopyrronium, and formoterol fumarate metered dose inhaler
BGF MDI 320/14.4/9.6 μgDrug
Also called BGF
Budesonide, glycopyrronium, and formoterol fumarate metered dose inhaler
BFF MDI 320/9.6 μgDrug
Also called BFF
Budesonide and formoterol fumarate metered dose inhaler
BFF pMDI 320/9 μgDrug
Also called Symbicort®
Budesonide/formoterol fumarate pressurized metered dose inhaler
| Study group | Role | What they receive |
|---|---|---|
| Budesonide, glycopyrronium, and formoterol fumarate (BGF) MDI 320/28.8/9.6 μg | Experimental | BGF MDI 320/28.8/9.6 μg Budesonide, glycopyrronium, and formoterol fumarate (PT010) Metered Dose Inhaler (MDI) Receives: Drug: BGF MDI 320/28.8/9.6 μg |
| BGF MDI 320/14.4/9.6 μg | Experimental | BGF MDI 320/14.4/9.6 μg Budesonide, glycopyrronium, and formoterol fumarate (PT010) Metered Dose Inhaler (MDI) Receives: Drug: BGF MDI 320/14.4/9.6 μg |
| Budesonide and formoterol fumarate (BFF) MDI 320/9.6 μg | Active comparator | BFF MDI 320/9.6 μg (Experimental/Comparator) Budesonide and formoterol fumarate (PT009) Metered Dose Inhaler (MDI) Receives: Drug: BFF MDI 320/9.6 μg |
| Symbicort® | Active comparator | Budesonide/ formoterol fumarate pressurized metered dose inhaler (pMDI) 320/9 μg Receives: Drug: BFF pMDI 320/9 μg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 24
Pooled (KALOS/LOGOS): Rate of Severe Asthma Exacerbations
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.
Measured: Up to 52 weeks
Secondary outcomes (14)
Change From Baseline in Morning Pre-dose Trough FEV1 (L) at 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.
Measured: 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 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.
Measured: Day 1
Percentage of Responders in ACQ-7 (≥0.5 Decrease Equals Response) at 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.
Measured: Week 24
Percentage of Responders in the 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.
Measured: 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.
Measured: Week 24
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.
Measured: Week 24
Pooled (KALOS/LOGOS): 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 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.
Measured: 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
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.
Measured: Up to 52 weeks
Pooled (KALOS/LOGOS): Time to First Severe Asthma Exacerbation
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.
Measured: Up to 52 weeks
Pooled (KALOS/LOGOS): Rate of Moderate or Severe Asthma Exacerbations
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.
Measured: Up to 52 weeks
Pooled (KALOS/LOGOS): 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 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.
Measured: Up to 52 weeks
Pooled (KALOS/LOGOS): Percentage of Responders in ACQ-7 (≥0.5 Decrease Equals Response) at 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.
Measured: Week 24
Pooled (KALOS/LOGOS): Percentage of Responders in ACQ-5 (≥0.5 Decrease Equals Response) at 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.
Measured: Week 24
Pooled (KALOS/LOGOS): Percentage of Responders in AQLQ(s)+12 (≥0.5 Increase Equals Response) at 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.
Measured: Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2020
- Study start15 Dec 2020
- Primary completion21 Mar 2025
- Study completion21 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2,274 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04609878
- Sponsor's protocol ID
- D5982C00007
- Other IDs
- 2023-505787-11, 2020-001520-34, 2023
- Acronym
- KALOS
- Status last verified
- Jun 2026
- First submitted
- 26 Oct 2020
- Last updated
- 30 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Publications
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.
PubMed 41692019Oba 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.
PubMed 36472162