Study to Assess PT010 in Adult and Adolescent Participants With Inadequately Controlled Asthma (LOGOS)
LOGOS
A Randomized, Double-Blind, Double Dummy, Parallel Group, Multicenter Variable Length Study to Assess the Efficacy and Safety of PT010 Relative to PT009 and Symbicort® in Adult and Adolescent Participants With Inadequately Controlled Asthma
3 other identifiers
interventional
2,187
16 countries
317
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 asthma
Started Mar 2021
Longer than P75 for phase_3 asthma
317 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 26, 2020
CompletedFirst Posted
Study publicly available on registry
October 30, 2020
CompletedStudy Start
First participant enrolled
March 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 20, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 20, 2025
CompletedApril 20, 2025
April 1, 2025
4.1 years
October 26, 2020
April 18, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Change from baseline in forced expiratory volume in 1 second (FEV1) area under the curve 0 to 3 hours (AUC0-3) 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
24 Weeks
Rate of severe asthma exacerbations
Primary end point(s) of Pooled Studies D5982C00007 and D5982C00008: Rate of severe asthma exacerbations
Up to 52 Weeks
Secondary Outcomes (11)
Change from baseline in morning pre-dose trough FEV1 at Week 24
24 Weeks
Percentage of responders in Asthma Control Questionnaire (ACQ)-7 (≥0.5 decrease equals response) at Week 24
24 Weeks
Percentage of responders in ACQ-5 (≥0.5 decrease equals response) at Week 24
24 Weeks
Percentage of responders in the Asthma Quality of Life Questionnaire for 12 years and older (AQLQ +12) (≥0.5 increase equals response) at Week 24
24 Weeks
Percentage of responders in the St. George's Respiratory Questionnaire (SGRQ) (≥4.0 unit decrease equals response) at Week 24
24 Weeks
- +6 more secondary outcomes
Study Arms (4)
Budesonide, glycopyrronium, and formoterol fumarate (BGF) MDI 320/28.8/9.6 μg
EXPERIMENTALBGF MDI 320/28.8/9.6 μg Budesonide, glycopyrronium, and formoterol fumarate (PT010) Metered Dose Inhaler (MDI)
BGF MDI 320/14.4/9.6 μg
EXPERIMENTALBGF MDI 320/14.4/9.6 μg Budesonide, glycopyrronium, and formoterol fumarate (PT010) Metered Dose Inhaler (MDI)
Budesonide and formoterol fumarate (BFF) MDI 320/9.6 μg
ACTIVE COMPARATORBFF MDI 320/9.6 μg (Experimental/Comparator) Budesonide and formoterol fumarate (PT009) Metered Dose Inhaler (MDI)
Symbicort®
ACTIVE COMPARATORBudesonide/ formoterol fumarate pressurized metered dose inhaler (pMDI) 320/9 μg
Interventions
Budesonide, glycopyrronium, and formoterol fumarate metered dose inhaler
Budesonide, glycopyrronium, and formoterol fumarate metered dose inhaler
Budesonide and formoterol fumarate metered dose inhaler
Budesonide/formoterol fumarate pressurized metered dose inhaler
Eligibility Criteria
You may qualify if:
- to 80 years of age, male and female, BMI \<40 kg/m2; females must be not of childbearing potential or using a form of highly effective birth control.
- Documented history of physician-diagnosed asthma \> and/or = 1 year prior to V1.
- Regularly using a stable daily ICS/LABA regimen (including a stable ICS dose) with medium-to-high ICS doses for at least 4 weeks prior to V1.
- ACQ-7 total score ≥1.5 at Visits 1, 3, and 5 (pre-randomization).
- FEV1 % (assessed as an average of the 60 and 30 minute pre-dose assessments) predicted normal at V1, 2, 3, 4, and 5 (pre-randomization)
- Participants \> and/or = 18 years of age: \< 80%
- Participants 12 to \<18 years of age: \< 90%
- FEV1 post-albuterol at V2 or V3 (if repeat needed). • Participants \> and/or = 18 years of age: Increase \> and/or = 12% and \> and/or = 200 mL.
- Participants 12 to \<18 years of age: Increase =12% either in the 12 months prior to Visit 1 or at Visit 2, or at Visit 3.
- Note: Even if there is documented history of reversibility, all participants must be assessed for reversibility at Visit 2 (and Visit 3, if reversibility is not demonstrated at Visit 2) to provide reversibility baseline data for characterization.
- Willing and, in the opinion of the Investigator, able to adjust current asthma therapy, as required by the protocol.
- Demonstrate acceptable MDI/pMDI administration technique.
- Received no asthma medication other than run-in BFF MDI BID and albuterol as needed during screening (except for allowed medications as defined in Table 9 and systemic corticosteroid or ICS for the treatment of an asthma exacerbation).
- eDiary 14-day compliance ≥70% during screening (defined as completing the daily eDiary for any 10 mornings and any 10 evenings and answering "Yes" to taking 2 puffs of run-in BFF MDI for any 10 mornings and 10 evenings in the last 14 days prior to randomization).
- No respiratory infection in the 4 weeks prior to randomization, or asthma exacerbation treated with systemic corticosteroid and/or additional ICS treatment in the 4 weeks prior to randomization.
You may not qualify if:
- \. Completed treatment for respiratory infection or asthma exacerbation with systemic corticosteroids within 4 weeks of V1.
- a. Participants where, in the opinion of the Investigator, treatment with biological therapy for asthma would be appropriate.
- b. Any marketed or investigational biologics within 3 months or 5 halflives of V1, whichever is longer and must not be used during study duration.
- \. 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).
- \. Current evidence of COPD.
- a. Oral and IV corticosteroid use (any dose) within 4 weeks of V1.
- b. 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.
- c. Depot corticosteroid use for any reason within 3 months of V1.
- \. Use of LAMA, either alone or as part of an inhaled combination therapy, in the 12 weeks prior to Visit 1.
- \. Use of oral beta2-agonist within 3 months of V1.
- \. 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.
- \. 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.
- \. 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).
- \. Hospitalization for asthma within 2 months of Visit 1.
- \. Known history of drug or alcohol abuse within 12 months of Visit 1.
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (317)
Research Site
Chandler, Arizona, 85224, United States
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Tempe, Arizona, 85283, United States
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Tucson, Arizona, 85741, United States
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Hot Springs, Arkansas, 71913, United States
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Bakersfield, California, 93301, United States
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Carlsbad, California, 92008, United States
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Huntington Beach, California, 92647, United States
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Lancaster, California, 93534, United States
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Long Beach, California, 90815, United States
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Mission Viejo, California, 92691, United States
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North Hollywood, California, 91606, United States
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Northridge, California, 91324, United States
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Rancho Cucamonga, California, 91730, United States
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Sacramento, California, 95823, United States
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San Diego, California, 92123, United States
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San Jose, California, 95117, United States
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Ventura, California, 93003, United States
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Walnut Creek, California, 94598, United States
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Colorado Springs, Colorado, 80907, United States
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Colorado Springs, Colorado, 80910, United States
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Wheat Ridge, Colorado, 80033, United States
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Newark, Delaware, 19713, United States
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Boca Raton, Florida, 33487, United States
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Clearwater, Florida, 33756, United States
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Clearwater, Florida, 33765, United States
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Cutler Bay, Florida, 33189, United States
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DeBary, Florida, 32713, United States
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Hialeah, Florida, 33016, United States
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Lakeland, Florida, 33813, United States
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Miami, Florida, 33135, United States
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Tampa, Florida, 33615, United States
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Acworth, Georgia, 30101, United States
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Atlanta, Georgia, 30322, United States
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Atlanta, Georgia, 30350, United States
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Snellville, Georgia, 30078, United States
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Boise, Idaho, 83706, United States
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Chicago, Illinois, 60621, United States
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Normal, Illinois, 61761, United States
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Peoria, Illinois, 61636, United States
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Evansville, Indiana, 47715, United States
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Marrero, Louisiana, 70072, United States
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Zachary, Louisiana, 70791, United States
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Baltimore, Maryland, 21224, United States
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White Marsh, Maryland, 21162, United States
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Fall River, Massachusetts, 02723, United States
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Farmington Hills, Michigan, 48336, United States
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Rochester, Michigan, 48307, United States
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Troy, Michigan, 48085, United States
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St Louis, Missouri, 63141, United States
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Warrensburg, Missouri, 64093, United States
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North Las Vegas, Nevada, 89030, United States
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Portsmouth, New Hampshire, 03801, United States
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Ocean City, New Jersey, 07712, United States
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Albuquerque, New Mexico, 87102, United States
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Brooklyn, New York, 11236, United States
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The Bronx, New York, 10459, United States
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The Bronx, New York, 10461, United States
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The Bronx, New York, 10468, United States
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Greensboro, North Carolina, 27405, United States
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Huntersville, North Carolina, 28078, United States
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Monroe, North Carolina, 28112, United States
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Columbus, Ohio, 43215, United States
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Portland, Oregon, 97202, United States
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Jenkintown, Pennsylvania, 19046, United States
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Philadelphia, Pennsylvania, 19107, United States
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Spartanburg, South Carolina, 29303, United States
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Knoxville, Tennessee, 37909, United States
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Amarillo, Texas, 79106, United States
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Cedar Park, Texas, 78613, United States
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Dallas, Texas, 75254, United States
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Denison, Texas, 75020, United States
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Forney, Texas, 75126, United States
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Houston, Texas, 77074, United States
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Houston, Texas, 77099, United States
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Lewisville, Texas, 75067, United States
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McKinney, Texas, 75069, United States
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North Richland Hills, Texas, 76180, United States
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Pearland, Texas, 77584, United States
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Plano, Texas, 75093, United States
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San Antonio, Texas, 78258, United States
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Sugar Land, Texas, 77478, United States
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Victoria, Texas, 77901, United States
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Roy, Utah, 84067, United States
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Abingdon, Virginia, 24210, United States
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Burke, Virginia, 22015, United States
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Williamsburg, Virginia, 23188, United States
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Milwaukee, Wisconsin, 53226, United States
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Milwaukee, Wisconsin, 53228, United States
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Botucatu, 18618-970, Brazil
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Porto Alegre, 9002-060, Brazil
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Porto Alegre, 90430-001, Brazil
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Porto Alegre, 90610-000, Brazil
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Porto Alegre, 91350-200, Brazil
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Santo André, 09080-110, Brazil
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São Paulo, 05403-000, Brazil
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Sorocaba, 18040-425, Brazil
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Baotou, 014010, China
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Beijing, 100020, China
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Changsha, 410005, China
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Changsha, 410008, China
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Changsha, 430033, China
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Changzhi, 46000, China
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Chengdu, 610072, China
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Chengdu, 611130, China
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Chizhou, 247099, China
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Chongqing, 400010, China
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Chongqing, 400038, China
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Dongguan, 523413, China
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Dongyang, 322100, China
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Fuzhou, 350025, China
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Guangzhou, 510062, China
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Guangzhou, 510100, China
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Guangzhou, 510120, China
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Guangzhou, 510180, China
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Guangzhou, 510280, China
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Guangzhou, 510630, China
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Haikou, 570208, China
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Haikou, 570311, China
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Hangzhou, 310005, China
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Hangzhou, 310009, China
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Hefei, 230000, China
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Hefei, 230011, China
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Hefei, 230061, China
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Huai'an, 223300, China
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Huizhou, 516001, China
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Jinan, 250014, China
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Jinhua, 321000, China
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Kunming, 650032, China
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Kunming, 650051, China
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Lanzhou, 730000, China
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Liuchow, 545006, China
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Luoyang, 471003, China
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Nanchang, 330006, China
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Nanchong, 637000, China
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Nanjing, 210006, China
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Nanjing, 210008, China
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Nanjing, 210009, China
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Nanjing, 210029, China
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Nanning, 530021, China
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Qingdao, 266000, China
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Qingdao, 266042, China
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Shanghai, 200025, China
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Shanghai, 200032, China
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Shanghai, 200065, China
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Shanghai, 200080, China
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Shanghai, 200092, China
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Shanghai, 200240, China
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Shanghai, 201199, China
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Shaoxing, 312000, China
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Shengyang, 110004, China
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Shenyang, 110001, China
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Shenyang, 110015, China
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Shenyang, 110075, China
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Shenzhen, 518020, China
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Shenzhen, 518036, China
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Shenzhen, 518039, China
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Shijiazhuang, 50051, China
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Taiyuan, 030001, China
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Taiyuan, 030032, China
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Taizhou, 318020, China
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Ürümqi, 830054, China
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Weifang, 261000, China
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Wuhan, 430010, China
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Wuhan, 430030, China
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Wuhu, 241000, China
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Xi'an, 710004, China
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Xi'an, 710077, China
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Xinxiang, 453002, China
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Xuzhou, 221000, China
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Xuzhou, 221009, China
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Yangzhou, 225001, China
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Yantai, 264000, China
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Yinchuan, 750001, China
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Yinchuan, 750004, China
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Yueyang, 414000, China
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Zhangzhou, 363099, China
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Zhanjiang, 524001, China
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Zhengzhou, 450000, China
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Zhuji, 311899, China
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Barranquilla, 080020, Colombia
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Bogotá, 110221, Colombia
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Cartagena, 130013, Colombia
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Medellín, 050621, Colombia
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Rionegro, 054047, Colombia
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Brandýs nad Labem, 250 01, Czechia
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Jindřichův Hradec, 377 01, Czechia
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Lovosice, 410 02, Czechia
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Mladá Boleslav, 293 01, Czechia
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Nový Bor, 473 01, Czechia
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Prague, 148 00, Czechia
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Prague, 190 00, Czechia
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Rokycany, 337 22, Czechia
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Strakonice, 38601, Czechia
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Teplice, 415 01, Czechia
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Varnsdorf, 407 47, Czechia
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Bamberg, 96049, Germany
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Berlin, 10119, Germany
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Berlin, 10367, Germany
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Berlin, 10717, Germany
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Berlin, 10787, Germany
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Berlin, 12159, Germany
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Berlin, 12203, Germany
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Berlin, 13187, Germany
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Darmstadt, 64283, Germany
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Frankfurt, 60596, Germany
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Frankfurt am Main, 60389, Germany
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Frankfurt am Main, 60596, Germany
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Fürstenwalde, 15517, Germany
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Geesthacht, 21502, Germany
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Hanover, 30449, Germany
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Hanover, D-30173, Germany
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Heidelberg, 69115, Germany
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Koblenz, 56068, Germany
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Landsberg, 86899, Germany
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Leipzig, 04103, Germany
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Leipzig, 04207, Germany
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Leipzig, 04299, Germany
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Mainz, 55128, Germany
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München-Pasing, 81241, Germany
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Witten, 58452, Germany
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Alexandroupoli, 68100, Greece
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Athens, 11521, Greece
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Athens, 11527, Greece
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Athens, 12462, Greece
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Athens, 17562, Greece
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Corfu, 49100, Greece
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Exohi Thessaloniki, 57010, Greece
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Ioannina, 45500, Greece
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Pátrai, 26500, Greece
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Thessaloniki, 56429, Greece
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Thessaloniki, 57010, Greece
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Ashkelon, 7830604, Israel
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Beersheba, 84101, Israel
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Haifa, 31096, Israel
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Haifa, 34362, Israel
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Holon, 5837738, Israel
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Jerusalem, 9103102, Israel
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Jerusalem, 9112001, Israel
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Kfar Saba, 4428164, Israel
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Petah Tikva, 4920235, Israel
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Rehovot, 76100, Israel
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Tel Aviv, 6423906, Israel
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Cuernavaca, 62290, Mexico
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Durango, 43080, Mexico
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Guadalajara, 44200, Mexico
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Mazatlán, 82000, Mexico
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Mérida, 97070, Mexico
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Monterrey, 64620, Mexico
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Monterrey, 64710, Mexico
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Monterrey, 64718, Mexico
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Veracruz, 91910, Mexico
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Villahermosa, 86035, Mexico
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Zapopan, 45138, Mexico
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Amadora, 2720-276, Portugal
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Braga, 4710, Portugal
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Coimbra, 3040-316, Portugal
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Figueira da Foz Municipality, 3094-001, Portugal
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Guimarães, 4835-044, Portugal
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Lisbon, 1649-035, Portugal
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Lisbon, 1998-018, Portugal
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Matosinhos Municipality, 4454-509, Portugal
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Ponce, 00717, Puerto Rico
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Ponce, 00780, Puerto Rico
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Chelyabinsk, 454106, Russia
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Izhevsk, 426035, Russia
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Kazan', 420008, Russia
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Kemerovo, 650002, Russia
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Moscow, 115522, Russia
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Moscow, 125284, Russia
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Omsk, 644050, Russia
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Penza, 440067, Russia
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Perm, 614000, Russia
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Saint Petersburg, 194354, Russia
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Saint Petersburg, 195257, Russia
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Saratov, 410028, Russia
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Saratov, 410053, Russia
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Tomsk, 634050, Russia
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Ulyanovsk, 432009, Russia
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Bojnice, 972 01, Slovakia
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Kežmarok, 060 01, Slovakia
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Košice, 04022, Slovakia
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Levice, 934 01, Slovakia
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Levice, 93401, Slovakia
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Nové Zámky, 94001, Slovakia
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Poprad, 058 01, Slovakia
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Prešov, 081 81, Slovakia
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Ružomberok, 034 26, Slovakia
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Šurany, 94201, Slovakia
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Topoľčany, 95501, Slovakia
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Žilina, 010 01, Slovakia
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Bloemfontein, 9301, South Africa
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Cape Town, 7700, South Africa
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Cape Town, 7764, South Africa
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Durban, 4001, South Africa
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Durban, 4091, South Africa
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Durban, 4093, South Africa
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Durban, 4450, South Africa
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eMkhomazi, 4170, South Africa
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Johannesburg, 2001, South Africa
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Lenasia, 1821, South Africa
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Lenasia Ext8, 1820, South Africa
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Panorama, 7500, South Africa
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Pretoria, 0186, South Africa
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Tygervalley, 7530, South Africa
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Adana, 1260, Turkey (Türkiye)
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Ankara, 06, Turkey (Türkiye)
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Istanbul, 34098, Turkey (Türkiye)
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Istanbul, 34844, Turkey (Türkiye)
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Izmir, 35110, Turkey (Türkiye)
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Mersin, 33343, Turkey (Türkiye)
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Pamukkale, 20070, Turkey (Türkiye)
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Blackpool, FY3 7EN, United Kingdom
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Bradford, BD9 6RJ, United Kingdom
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Corby, NN17 2UR, United Kingdom
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Hull, HU16 5JQ, United Kingdom
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Leicester, LE5 4LJ, United Kingdom
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Rhyl, LL18 1DA, United Kingdom
Related Publications (1)
Oba Y, Anwer S, Maduke T, Patel T, Dias S. Effectiveness and tolerability of dual and triple combination inhaler therapies compared with each other and varying doses of inhaled corticosteroids in adolescents and adults with asthma: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2022 Dec 6;12(12):CD013799. doi: 10.1002/14651858.CD013799.pub2.
PMID: 36472162DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robert Wise, MD
Johns Hopkins University
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 26, 2020
First Posted
October 30, 2020
Study Start
March 1, 2021
Primary Completion
March 20, 2025
Study Completion
March 20, 2025
Last Updated
April 20, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- 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
- 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
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