AsthmaPhase 3LOGOSNCT04609904
Study to Assess PT010 in Adult and Adolescent Participants With Inadequately Controlled Asthma (LOGOS)
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 317 sites in 16 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
- 2,187 participants
- Where
- 317 sitesin 16 countries
- Study dates
- 1 Mar 2021to 20 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 > and/or = 18 years of age: < 80%
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- 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 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.
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- 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
Trial locations and contacts
317 sites in 16 countries.
317 sites in 16 countries
United States88 sites
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Abingdon, Virginia, 24210
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Acworth, Georgia, 30101
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Albuquerque, New Mexico, 87102
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Amarillo, Texas, 79106
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Atlanta, Georgia, 30322
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Atlanta, Georgia, 30350
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Bakersfield, California, 93301
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Baltimore, Maryland, 21224
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Boca Raton, Florida, 33487
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Boise, Idaho, 83706
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Brooklyn, New York, 11236
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Burke, Virginia, 22015
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Carlsbad, California, 92008
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Cedar Park, Texas, 78613
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Chandler, Arizona, 85224
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Chicago, Illinois, 60621
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Clearwater, Florida, 33756
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Clearwater, Florida, 33765
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Colorado Springs, Colorado, 80907
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Colorado Springs, Colorado, 80910
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Columbus, Ohio, 43215
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Cutler Bay, Florida, 33189
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Dallas, Texas, 75254
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DeBary, Florida, 32713
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Denison, Texas, 75020
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Evansville, Indiana, 47715
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Fall River, Massachusetts, 02723
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Farmington Hills, Michigan, 48336
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Forney, Texas, 75126
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Greensboro, North Carolina, 27405
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Hialeah, Florida, 33016
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Hot Springs, Arkansas, 71913
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Houston, Texas, 77074
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Houston, Texas, 77099
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Huntersville, North Carolina, 28078
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Huntington Beach, California, 92647
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Jenkintown, Pennsylvania, 19046
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Knoxville, Tennessee, 37909
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Lakeland, Florida, 33813
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Lancaster, California, 93534
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Lewisville, Texas, 75067
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Long Beach, California, 90815
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Marrero, Louisiana, 70072
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McKinney, Texas, 75069
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Miami, Florida, 33135
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Milwaukee, Wisconsin, 53226
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Milwaukee, Wisconsin, 53228
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Mission Viejo, California, 92691
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Monroe, North Carolina, 28112
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Newark, Delaware, 19713
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Normal, Illinois, 61761
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North Hollywood, California, 91606
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North Las Vegas, Nevada, 89030
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North Richland Hills, Texas, 76180
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Northridge, California, 91324
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Ocean City, New Jersey, 07712
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Pearland, Texas, 77584
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Peoria, Illinois, 61636
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Philadelphia, Pennsylvania, 19107
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Plano, Texas, 75093
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Portland, Oregon, 97202
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Portsmouth, New Hampshire, 03801
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Rancho Cucamonga, California, 91730
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Rochester, Michigan, 48307
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Roy, Utah, 84067
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Sacramento, California, 95823
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San Antonio, Texas, 78258
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San Diego, California, 92123
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San Jose, California, 95117
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Snellville, Georgia, 30078
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Spartanburg, South Carolina, 29303
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St Louis, Missouri, 63141
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Sugar Land, Texas, 77478
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Tampa, Florida, 33615
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Tempe, Arizona, 85283
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The Bronx, New York, 10459
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The Bronx, New York, 10461
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The Bronx, New York, 10468
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Troy, Michigan, 48085
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Tucson, Arizona, 85741
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Ventura, California, 93003
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Victoria, Texas, 77901
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Walnut Creek, California, 94598
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Warrensburg, Missouri, 64093
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Wheat Ridge, Colorado, 80033
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White Marsh, Maryland, 21162
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Williamsburg, Virginia, 23188
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Zachary, Louisiana, 70791
China83 sites
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Baotou, 014010
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Beijing, 100020
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Changsha, 410005
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Changsha, 410008
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Changsha, 430033
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Changzhi, 46000
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Chengdu, 610072
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Chengdu, 611130
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Chizhou, 247099
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Chongqing, 400010
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Chongqing, 400038
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Dongguan, 523413
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Dongyang, 322100
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Fuzhou, 350025
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Guangzhou, 510062
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Guangzhou, 510100
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Guangzhou, 510120
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Guangzhou, 510180
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Guangzhou, 510280
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Guangzhou, 510630
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Haikou, 570208
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Haikou, 570311
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Hangzhou, 310005
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Hangzhou, 310009
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Hefei, 230000
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Hefei, 230011
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Hefei, 230061
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Huai'an, 223300
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Huizhou, 516001
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Jinan, 250014
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Jinhua, 321000
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Kunming, 650032
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Kunming, 650051
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Lanzhou, 730000
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Liuzhou, 545006
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Luoyang, 471003
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Nanchang, 330006
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Nanchong, 637000
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Nanjing, 210006
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Nanjing, 210008
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Nanjing, 210009
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Nanjing, 210029
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Nanning, 530021
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Qingdao, 266000
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Qingdao, 266042
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Shanghai, 200025
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Shanghai, 200032
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Shanghai, 200065
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Shanghai, 200080
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Shanghai, 200092
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Shanghai, 200240
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Shanghai, 201199
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Shaoxing, 312000
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Shengyang, 110004
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Shenyang, 110001
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Shenyang, 110015
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Shenyang, 110075
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Shenzhen, 518020
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Shenzhen, 518036
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Shenzhen, 518039
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Shijiazhuang, 50051
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Taiyuan, 030001
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Taiyuan, 030032
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Taizhou, 318020
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Ürümqi, 830054
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Weifang, 261000
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Wuhan, 430010
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Wuhan, 430030
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Wuhu, 241000
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Xi'an, 710004
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Xi'an, 710077
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Xinxiang, 453002
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Xuzhou, 221000
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Xuzhou, 221009
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Yangzhou, 225001
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Yantai, 264000
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Yinchuan, 750001
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Yinchuan, 750004
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Yueyang, 414000
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Zhangzhou, 363099
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Zhanjiang, 524001
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Zhengzhou, 450000
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Zhuji, 311899
Germany25 sites
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Bamberg, 96049
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Berlin, 10119
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Berlin, 10367
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Berlin, 10717
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Berlin, 10787
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Berlin, 12159
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Berlin, 12203
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Berlin, 13187
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Darmstadt, 64283
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Frankfurt, 60596
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Frankfurt am Main, 60389
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Frankfurt am Main, 60596
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Fürstenwalde, 15517
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Geesthacht, 21502
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Hanover, 30449
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Hanover, D-30173
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Heidelberg, 69115
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Koblenz, 56068
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Landsberg, 86899
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Leipzig, 04103
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Leipzig, 04207
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Leipzig, 04299
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Mainz, 55128
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München-Pasing, 81241
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Witten, 58452
Russia15 sites
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Chelyabinsk, 454106
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Izhevsk, 426035
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Kazan', 420008
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Kemerovo, 650002
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Moscow, 115522
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Moscow, 125284
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Omsk, 644050
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Penza, 440067
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Perm, 614000
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Saint Petersburg, 194354
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Saint Petersburg, 195257
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Saratov, 410028
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Saratov, 410053
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Tomsk, 634050
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Ulyanovsk, 432009
South Africa14 sites
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Bloemfontein, 9301
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Cape Town, 7700
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Cape Town, 7764
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Durban, 4001
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Durban, 4091
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Durban, 4093
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Durban, 4450
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eMkhomazi, 4170
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Johannesburg, 2001
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Lenasia, 1821
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Lenasia Ext8, 1820
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Panorama, 7500
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Pretoria, 0186
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Tygervalley, 7530
Slovakia12 sites
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Bojnice, 972 01
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Kežmarok, 060 01
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Košice, 04022
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Levice, 934 01
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Levice, 93401
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Nové Zámky, 94001
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Poprad, 058 01
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Prešov, 081 81
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Ružomberok, 034 26
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Šurany, 94201
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Topoľčany, 95501
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Žilina, 010 01
Czechia11 sites
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Brandýs nad Labem, 250 01
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Jindřichův Hradec, 377 01
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Lovosice, 410 02
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Mladá Boleslav, 293 01
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Nový Bor, 473 01
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Prague, 148 00
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Prague, 190 00
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Rokycany, 337 22
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Strakonice, 38601
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Teplice, 415 01
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Varnsdorf, 407 47
Greece11 sites
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Alexandroupoli, 68100
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Athens, 11521
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Athens, 11527
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Athens, 12462
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Athens, 17562
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Corfu, 49100
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Exohi Thessaloniki, 57010
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Ioannina, 45500
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Pátrai, 26500
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Thessaloniki, 56429
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Thessaloniki, 57010
Israel11 sites
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Ashkelon, 7830604
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Beersheba, 84101
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Haifa, 31096
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Haifa, 34362
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Holon, 5837738
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Jerusalem, 9103102
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Jerusalem, 9112001
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Kfar Saba, 4428164
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Petah Tikva, 4920235
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Rehovot, 76100
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Tel Aviv, 6423906
Mexico11 sites
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Cuernavaca, 62290
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Durango, 43080
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Guadalajara, 44200
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Mazatlán, 82000
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Mérida, 97070
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Monterrey, 64620
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Monterrey, 64710
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Monterrey, 64718
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Veracruz, 91910
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Villahermosa, 86035
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Zapopan, 45138
Brazil8 sites
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Botucatu, 18618-970
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Porto Alegre, 9002-060
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Porto Alegre, 90430-001
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Porto Alegre, 90610-000
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Porto Alegre, 91350-200
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Santo André, 09080-110
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São Paulo, 05403-000
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Sorocaba, 18040-425
Portugal8 sites
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Amadora, 2720-276
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Braga, 4710
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Coimbra, 3040-316
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Figueira da Foz Municipality, 3094-001
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Guimarães, 4835-044
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Lisbon, 1649-035
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Lisbon, 1998-018
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Matosinhos Municipality, 4454-509
Turkey (Türkiye)7 sites
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Adana, 1260
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Ankara, 06
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Istanbul, 34098
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Istanbul, 34844
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Izmir, 35110
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Mersin, 33343
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Pamukkale, 20070
United Kingdom6 sites
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Blackpool, FY3 7EN
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Bradford, BD9 6RJ
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Corby, NN17 2UR
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Hull, HU16 5JQ
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Leicester, LE5 4LJ
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Rhyl, LL18 1DA
Colombia5 sites
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Barranquilla, 080020
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Bogotá, 110221
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Cartagena, 130013
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Medellín, 050621
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Rionegro, 054047
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 (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.
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 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 (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.
Measured: 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.
Measured: 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.
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 (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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
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 start1 Mar 2021
- Primary completion20 Mar 2025
- Study completion20 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
- 2,187 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Wise, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04609904
- Sponsor's protocol ID
- D5982C00008
- Other IDs
- 2023-505786-88, 2020-001521-31, 2023
- Acronym
- LOGOS
- Status last verified
- Jun 2026
- First submitted
- 26 Oct 2020
- Last updated
- 2 Jul 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