Study to Evaluate Tezepelumab in Adults & Adolescents With Severe Uncontrolled Asthma
NAVIGATOR
A Multicentre, Randomized, Double-Blind, Placebo Controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of Tezepelumab in Adults and Adolescents With Severe Uncontrolled Asthma (NAVIGATOR)
1 other identifier
interventional
1,061
17 countries
284
Brief Summary
A Multicentre, Randomized, Double-Blind, Placebo Controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of Tezepelumab in Adults and Adolescents with Severe Uncontrolled Asthma
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 Nov 2017
Typical duration for phase_3 asthma
284 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
November 9, 2017
CompletedFirst Posted
Study publicly available on registry
November 20, 2017
CompletedStudy Start
First participant enrolled
November 23, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 8, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 12, 2020
CompletedResults Posted
Study results publicly available
November 26, 2021
CompletedNovember 26, 2021
October 1, 2021
2.8 years
November 9, 2017
September 7, 2021
October 29, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma
The annual exacerbation rate is based on unadjudicated exacerbations reported by the investigator in the eCRF. The analysis is based on the primary population (Full Analysis Set)
From randomisation to Study Week 52.
Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma in Subjects With Baseline Eosinophils < 300 Cells/uL
The annual exacerbation rate is based on unadjudicated exacerbations reported by the investigator in the eCRF. This analysis is based on subjects with baseline eosinophils \< 300 cells/uL
From randomisation to Study Week 52.
Secondary Outcomes (26)
Mean Change From Baseline at Week 52 in Pre-dose/Pre-bronchodilator (Pre-BD) Forced Expiratory Volume in 1 Second (FEV1) (L) (Key Secondary Endpoint)
From randomisation to Study Week 52
Mean Change From Baseline at Week 52 in Standardized Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ(S)+12) Total Score (Key Secondary Endpoint)
From randomisation to Study Week 52
Mean Change From Baseline at Week 52 in Asthma Control Questionnaire-6(ACQ-6) (Key Secondary Endpoint)
From randomisation to Study Week 52
Mean Change From Baseline at Week 52 in Asthma Symptom Diary (Key Secondary Endpoint)
From randomisation to Study Week 52
Time to First Asthma Exacerbation
From randomisation to Study Week 52
- +21 more secondary outcomes
Other Outcomes (3)
Annual Asthma Exacerbation Rate Associated With Hospitalisations
From randomisation to Study Week 52
Annual Asthma Exacerbation Rate Using Adjudicated Data
From randomisation to Study Week 52
Annual Asthma Exacerbation Rate Associated With Emergency Room (ER) Visit or Hospitalisation Using Adjudicated Data
From randomisation to Study Week 52
Study Arms (2)
Tezepelumab
EXPERIMENTALTezepelumab: Tezepelumab subcutaneous injection
Placebo
PLACEBO COMPARATORPlacebo: Placebo subcutaneous injection
Interventions
Tezepelumab subcutaneous injection
Eligibility Criteria
You may qualify if:
- Age. 12-80
- Documented physician-diagnosed asthma for at least 12 months
- Subjects who have received a physician-prescribed asthma controller medication with medium or high dose ICS for at least 12 months.
- Documented treatment with a total daily dose of either medium or high dose ICS (≥ 500 µg fluticasone propionate dry powder formulation equivalent total daily dose) for at least 3 months.
- At least one additional maintenance asthma controller medication is required according to standard practice of care and must be documented for at least 3 months.
- Morning pre-BD FEV1 \<80% predicted normal (\<90% for subjects 12-17 yrs)
- Evidence of asthma as documented by either: Documented historical reversibility of FEV1 ≥12% and ≥200 mL in the previous 12 months OR Post-BD (albuterol/salbutamol) reversibility of FEV1 ≥12% and ≥200 mL during screening.
- Documented history of at least 2 asthma exacerbation events within 12 months.
- ACQ-6 score ≥1.5 at screening and on day of randomization
You may not qualify if:
- Pulmonary disease other than asthma.
- History of cancer.
- History of a clinically significant infection.
- Current smokers or subjects with smoking history ≥10 pack-years and subjects using vaping products, including electronic cigarettes.
- History of chronic alcohol or drug abuse within 12 months.
- Hepatitis B, C or HIV.
- Pregnant or breastfeeding.
- History of anaphylaxis following any biologic therapy.
- Subject randomized in the current study or previous tezepelumab studies.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- Amgencollaborator
Study Sites (289)
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Dothan, Alabama, 36303, United States
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Foley, Alabama, 36535, United States
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Gilbert, Arizona, 85234, United States
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Tucson, Arizona, 85724, United States
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Bakersfield, California, 93301, United States
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Encinitas, California, 92024, United States
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Huntington Beach, California, 92647, United States
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Long Beach, California, 90808, United States
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Los Angeles, California, 90025, United States
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Mission Viejo, California, 92691, United States
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Newport Beach, California, 92663, United States
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Northridge, California, 91324, United States
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Palm Desert, California, 92260, United States
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Rolling Hills Estates, California, 90274, United States
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Walnut Creek, California, 94598, United States
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Westminster, California, 92683, United States
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Denver, Colorado, 80206, United States
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New Haven, Connecticut, 06520, United States
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Celebration, Florida, 34747, United States
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Kissimmee, Florida, 34741, United States
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Kissimmee, Florida, 34744, United States
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Orlando, Florida, 32803, United States
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Orlando, Florida, 32825, United States
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Panama City, Florida, 32405, United States
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Port Charlotte, Florida, 33952, United States
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Sarasota, Florida, 34239, United States
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Sebring, Florida, 33870, United States
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St. Petersburg, Florida, 33704, United States
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St. Petersburg, Florida, 33710, United States
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St. Petersburg, Florida, 33713, United States
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Tampa, Florida, 33607, United States
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Winter Park, Florida, 32789, United States
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Fayetteville, Georgia, 30214, United States
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Gainesville, Georgia, 30501, United States
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Savannah, Georgia, 31406, United States
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Stockbridge, Georgia, 30281, United States
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Boise, Idaho, 83706, United States
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Michigan City, Indiana, 46360, United States
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Fort Mitchell, Kentucky, 41017, United States
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Louisville, Kentucky, 40215, United States
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Lake Charles, Louisiana, 70601, United States
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Zachary, Louisiana, 70791, United States
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White Marsh, Maryland, 21162, United States
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Boston, Massachusetts, 02115, United States
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Fall River, Massachusetts, 02721, United States
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Ann Arbor, Michigan, 48109, United States
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Flint, Michigan, 48504, United States
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Novi, Michigan, 48375, United States
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Port Huron, Michigan, 48060, United States
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Troy, Michigan, 48085, United States
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St Louis, Missouri, 63108, United States
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St Louis, Missouri, 63141, United States
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Lincoln, Nebraska, 68505, United States
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Las Vegas, Nevada, 89106, United States
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Las Vegas, Nevada, 89119, United States
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Northfield, New Jersey, 08225, United States
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Toms River, New Jersey, 08755, United States
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Brooklyn, New York, 11235, United States
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New York, New York, 10016, United States
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New York, New York, 10022, United States
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New York, New York, 10029, United States
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New York, New York, 10032, United States
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The Bronx, New York, 10459, United States
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The Bronx, New York, 10465, United States
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Valhalla, New York, 10595, United States
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Charlotte, North Carolina, 28277, United States
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Gastonia, North Carolina, 28054, United States
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Winston-Salem, North Carolina, 27104, United States
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Cincinnati, Ohio, 45229, United States
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Cincinnati, Ohio, 45231, United States
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Mayfield Heights, Ohio, 44124, United States
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Toledo, Ohio, 43608, United States
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Edmond, Oklahoma, 73034, United States
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Oklahoma City, Oklahoma, 73120, United States
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Tulsa, Oklahoma, 74136, United States
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Medford, Oregon, 97504, United States
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Pittsburgh, Pennsylvania, 15243, United States
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Warwick, Rhode Island, 02886, United States
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Anderson, South Carolina, 29621, United States
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Columbia, South Carolina, 29204, United States
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Greenville, South Carolina, 29607, United States
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Allen, Texas, 75013, United States
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Amarillo, Texas, 79106, United States
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Boerne, Texas, 78006, United States
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Dallas, Texas, 75225, United States
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Dallas, Texas, 75230, United States
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Lampasas, Texas, 76550, United States
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McAllen, Texas, 78504, United States
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Plano, Texas, 75093, United States
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San Antonio, Texas, 78251, United States
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Manassas, Virginia, 20110, United States
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Richmond, Virginia, 23220, United States
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Richmond, Virginia, 23235, United States
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Cudahy, Wisconsin, 53110, United States
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Madison, Wisconsin, 53792, United States
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Buenos Aires, C1414AIF, Argentina
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CABA, C1056ABJ, Argentina
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CABA, C1425BEN, Argentina
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Ciudad de Buenos Aires, 1425, Argentina
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Córdoba, X5003DCE, Argentina
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Mendoza, 5500, Argentina
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Nueve de Julio, B6500EZL, Argentina
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Quilmes, B1878FNR, Argentina
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Campbelltown, 2560, Australia
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Kent Town, 5067, Australia
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Melbourne, 3004, Australia
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Nedlands, 6009, Australia
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New Lambton, 2310, Australia
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Spearwood, 6163, Australia
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Westmead, 2145, Australia
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Woolloongabba, 4102, Australia
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Klagenfurt, 9020, Austria
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Linz, 4020, Austria
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Salzburg, 5020, Austria
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Vienna, 1090, Austria
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Vienna, 1130, Austria
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Blumenau, 89030-101, Brazil
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Botucatu, 18618-970, Brazil
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Curitiba, 80060-900, Brazil
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Porto Alegre, 9002-060, Brazil
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Porto Alegre, 90035-074, Brazil
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Porto Alegre, 90610-000, Brazil
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Porto Alegre, 90619-900, Brazil
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Porto Alegre, 91350-200, Brazil
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Recife, 50070-550, Brazil
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Salvador, 41940-455, Brazil
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Santo André, 09080-110, Brazil
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São Bernardo do Campo, 09750-420, Brazil
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Sorocaba, 18040-425, Brazil
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Vitória, 29055-450, Brazil
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Calgary, Alberta, T2N 4Z6, Canada
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Sherwood Park, Alberta, T8L 0N2, Canada
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Vancouver, British Columbia, V5Z 1M9, Canada
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Ajax, Ontario, L1S 2J5, Canada
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Burlington, Ontario, L7N 3V2, Canada
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Mississauga, Ontario, L5A 3V4, Canada
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Ottawa, Ontario, K1G 6C6, Canada
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Windsor, Ontario, N8X 1T3, Canada
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Montreal, Quebec, H4J 1C5, Canada
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Québec, Quebec, G1G 3Y8, Canada
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Saint-Charles-Borromée, Quebec, J6E 2B4, Canada
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Trois-Rivières, Quebec, G8T 7A1, Canada
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Brest, 29609, France
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Grenoble, 38043, France
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Le Kremlin-Bicêtre, 94275, France
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Lille, 59037, France
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Lyon, 69317, France
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Marseille, 13015, France
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Montpellier, 34295, France
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Nantes, 44093, France
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Paris, 75015, France
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Paris, 75571, France
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Paris, 75877, France
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Pessac, 33604, France
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Strasbourg, 67091, France
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Toulouse, 31059, France
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Bamberg, 96049, Germany
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Berlin, 10367, Germany
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Berlin, 10717, Germany
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Frankfurt, 60596, Germany
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Frankfurt am Main, 60596, Germany
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Hamburg, 20354, Germany
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Hamburg, 22299, Germany
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Hanover, 30625, Germany
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Hanover, D-30173, Germany
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Landsberg, 86899, Germany
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Leipzig, 04103, Germany
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Leipzig, 04357, Germany
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Lübeck, 23552, Germany
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Mainz, 55131, Germany
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Ashkelon, 7830604, Israel
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Haifa, 34362, Israel
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Jerusalem, 91031, Israel
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Jerusalem, 91120, Israel
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Kfar Saba, 49281, Israel
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Rehovot, 7661041, Israel
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Bunkyō City, 113-8431, Japan
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Chūōku, 103-0022, Japan
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Chūōku, 103-0028, Japan
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Chūōku, 104-0031, Japan
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Edogawa-ku, 134-0083, Japan
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Fujieda-shi, 426-8677, Japan
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Fukuoka, 810-0001, Japan
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Fukuoka, 811-1394, Japan
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Fukuoka, 815-8588, Japan
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Habikino-shi, 583-8588, Japan
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Hamamatsu, 431-3192, Japan
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Higashiibaraki-gun, 311-3193, Japan
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Himeji-shi, 672-8064, Japan
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Hitachi-shi, 317-0077, Japan
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Itabashi-ku, 173-0003, Japan
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Itabashi-ku, 173-8610, Japan
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Kagoshima, 890-0073, Japan
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Kagoshima, 890-8520, Japan
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Kanazawa, 920-8530, Japan
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Kanazawa, 920-8641, Japan
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Kasuga-shi, 816-0813, Japan
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Kishiwada-shi, 596-8501, Japan
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Kitakyushu, 802-0052, Japan
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Koga-shi, 811-3195, Japan
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Matsusaka-shi, 515-8544, Japan
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Meguro-ku, 152-0021, Japan
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Meguro-ku, 152-8621, Japan
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Minatoku, 105-0003, Japan
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Minatoku, 105-0004, Japan
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Minatoku, 108-0014, Japan
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Mizunami-shi, 509-6134, Japan
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Nagaoka-shi, 940-2085, Japan
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Niigata, 951-8520, Japan
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Ogaki-shi, 503-8502, Japan
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Ohota-ku, 145-0063, Japan
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Omuta-shi, 837-0911, Japan
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Sagamihara-shi, 228-0815, Japan
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Sapporo, 001-0901, Japan
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Sapporo, 064-0804, Japan
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Setagaya-ku, 157-0072, Japan
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Shibuya-ku, 150-0013, Japan
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Shinagawa-ku, 140-8522, Japan
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Shinagawa-ku, 142-8666, Japan
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Shinjuku-ku, 162-8655, Japan
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Shinjuku-ku, 162-8666, Japan
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Sumida-ku, 130-0015, Japan
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Takamatsu, 761-8073, Japan
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Toshima-ku, 170-0003, Japan
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Toshima-ku, 171-0014, Japan
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Ube, 755-8505, Japan
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Yokkaichi-shi, 510-8567, Japan
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Yokohama, 223-0059, Japan
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Yokohama, 236-0004, Japan
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Yokohama, 236-0024, Japan
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Yoshida-gun, 910-1193, Japan
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Izhevsk, 426035, Russia
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Moscow, 115093, Russia
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Moscow, 115522, Russia
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Saint Petersburg, 193231, Russia
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Jeddah, 21423, Saudi Arabia
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Jeddah, 22252, Saudi Arabia
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Bellville, 7530, South Africa
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Boksburg North, 1460, South Africa
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Cape Town, 7570, 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, 4092, South Africa
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Durban, 4450, South Africa
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eMkhomazi, 4170, South Africa
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Johannesburg, 1724, South Africa
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Johannesburg, 1829, South Africa
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Johannesburg, 2113, South Africa
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Lenasia Ext8, 1820, South Africa
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Middelburg, 1055, South Africa
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Mowbray, 7700, South Africa
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Parow, 7505, South Africa
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Pretoria, 0157, South Africa
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Witbank, 1035, South Africa
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Bucheon-si, 14584, South Korea
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Cheongju-si, 28644, South Korea
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Daegu, 41404, South Korea
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Daegu, 42415, South Korea
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Jeju City, 690-767, South Korea
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Jeonju, 54907, South Korea
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Seongnam-si, 13620, South Korea
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Seoul, 02447, South Korea
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Seoul, 03080, South Korea
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Seoul, 03312, South Korea
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Seoul, 03722, South Korea
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Seoul, 05505, South Korea
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Seoul, 06351, South Korea
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Seoul, 06591, South Korea
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Seoul, 07985, South Korea
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Seoul, 08308, South Korea
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Seoul, 150-713, South Korea
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Suwon, 16499, South Korea
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Hsinchu, 300, Taiwan
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Kaohsiung City, 80756, Taiwan
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Kaohsiung City, 82445, Taiwan
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Kaohsiung Hsien, TAIWAN, Taiwan
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Taichung, 40443, Taiwan
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Tainan, 70403, Taiwan
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Taipei, 220216, Taiwan
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Taipei, 235, Taiwan
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Yilan, 260, Taiwan
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Ivano-Frankivsk, 76018, Ukraine
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Kharkiv Region, 61075, Ukraine
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London, SW3 6NP, United Kingdom
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Hanoi, 100000, Vietnam
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Hanoi, 10000, Vietnam
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Hà Nội, 100000, Vietnam
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Ho Chi Minh City, 70000, Vietnam
Related Publications (15)
Feleszko W, Caminati M, Gern JE, Johnston SL, Marchese C, Clarke D, Ambrose CS, Lindsley AW. Effect of tezepelumab on asthma exacerbations co-occurring with infection-attributed acute respiratory illnesses. Ann Allergy Asthma Immunol. 2026 Jan;136(1):61-65.e1. doi: 10.1016/j.anai.2025.09.015. Epub 2025 Oct 8.
PMID: 41072729DERIVEDYang X, Wang L, Huang K, Tang W, Berame EJ, Park HS, Hunter G, Jiang W, Wu CC, Min CW, Domek-Zielinska K, Lal H, Molfino NA, Ponnarambil SS, Zhong N. Efficacy and Safety of Tezepelumab in Adults With Severe, Uncontrolled Asthma in Asia: Results From the Phase 3 DIRECTION Study. J Allergy Clin Immunol Pract. 2025 Nov;13(11):3011-3020.e9. doi: 10.1016/j.jaip.2025.07.046. Epub 2025 Aug 7.
PMID: 40782846DERIVEDPavord ID, Brightling CE, Korn S, Martin NL, Ponnarambil SS, Molfino NA, Parnes JR, Ambrose CS. Tezepelumab can Restore Normal Lung Function in Patients with Severe, Uncontrolled Asthma: Pooled Results from the PATHWAY and NAVIGATOR Studies. Pulm Ther. 2025 Jun;11(2):315-325. doi: 10.1007/s41030-025-00294-2. Epub 2025 Apr 26.
PMID: 40285963DERIVEDJacobs JS, Han JK, Lee JK, Laidlaw TM, Martin NL, Caveney S, Ambrose CS, Martin N, Spahn JD, Hoyte FCL. Effect of Tezepelumab on Sino-Nasal Outcome Test (SNOT)-22 Domain and Symptom-Specific Scores in Patients with Severe, Uncontrolled Asthma and a History of Chronic Rhinosinusitis with Nasal Polyps. Adv Ther. 2025 Jan;42(1):510-522. doi: 10.1007/s12325-024-03006-5. Epub 2024 Nov 8.
PMID: 39514041DERIVEDWechsler ME, Brusselle G, Virchow JC, Bourdin A, Kostikas K, Llanos JP, Roseti SL, Ambrose CS, Hunter G, Jackson DJ, Castro M, Lugogo N, Pavord ID, Martin N, Brightling CE. Clinical response and on-treatment clinical remission with tezepelumab in a broad population of patients with severe, uncontrolled asthma: results over 2 years from the NAVIGATOR and DESTINATION studies. Eur Respir J. 2024 Dec 5;64(6):2400316. doi: 10.1183/13993003.00316-2024. Print 2024 Dec.
PMID: 39326921DERIVEDCarr TF, Moore WC, Kraft M, Brusselle G, Castro M, Chupp GL, Wechsler ME, Hunter G, Lindsley AW, Llanos JP, Burke LK, Chandarana S, Ambrose CS. Efficacy of Tezepelumab in Patients with Severe, Uncontrolled Asthma Across Multiple Clinically Relevant Subgroups in the NAVIGATOR Study. Adv Ther. 2024 Jul;41(7):2978-2990. doi: 10.1007/s12325-024-02889-8. Epub 2024 May 27.
PMID: 38802635DERIVEDCorren J, Menzies-Gow A, Bimmel J, McGuinness A, Almqvist G, Bowen K, Griffiths JM, Ponnarambil S, Bourdin A, Israel E, Colice G, Brightling CE, Wechsler ME; PATHWAY and NAVIGATOR study investigators. Tezepelumab for the treatment of severe asthma: a plain language summary of the PATHWAY and NAVIGATOR studies. Immunotherapy. 2023 Nov;15(16):1327-1340. doi: 10.2217/imt-2023-0109. Epub 2023 Sep 29.
PMID: 37772607DERIVEDMenzies-Gow A, Ambrose CS, Colice G, Hunter G, Cook B, Molfino NA, Llanos JP, Israel E. Effect of Tezepelumab on Lung Function in Patients With Severe, Uncontrolled Asthma in the Phase 3 NAVIGATOR Study. Adv Ther. 2023 Nov;40(11):4957-4971. doi: 10.1007/s12325-023-02659-y. Epub 2023 Sep 19.
PMID: 37723356DERIVEDPavord ID, Hoyte FCL, Lindsley AW, Ambrose CS, Spahn JD, Roseti SL, Cook B, Griffiths JM, Hellqvist A, Martin N, Llanos JP, Martin N, Colice G, Corren J. Tezepelumab reduces exacerbations across all seasons in patients with severe, uncontrolled asthma (NAVIGATOR). Ann Allergy Asthma Immunol. 2023 Nov;131(5):587-597.e3. doi: 10.1016/j.anai.2023.08.015. Epub 2023 Aug 23.
PMID: 37619779DERIVEDMenzies-Gow A, Bourdin A, Chupp G, Israel E, Hellqvist A, Hunter G, Roseti SL, Ambrose CS, Llanos JP, Cook B, Corren J, Colice G. Effect of tezepelumab on healthcare utilization in patients with severe, uncontrolled asthma: The NAVIGATOR study. Ann Allergy Asthma Immunol. 2023 Sep;131(3):343-348.e2. doi: 10.1016/j.anai.2023.05.028. Epub 2023 May 30.
PMID: 37263380DERIVEDCorren J, Menzies-Gow A, Chupp G, Israel E, Korn S, Cook B, Ambrose CS, Hellqvist A, Roseti SL, Molfino NA, Llanos JP, Martin N, Bowen K, Griffiths JM, Parnes JR, Colice G. Efficacy of Tezepelumab in Severe, Uncontrolled Asthma: Pooled Analysis of the PATHWAY and NAVIGATOR Clinical Trials. Am J Respir Crit Care Med. 2023 Jul 1;208(1):13-24. doi: 10.1164/rccm.202210-2005OC.
PMID: 37015033DERIVEDMenzies-Gow A, Wechsler ME, Brightling CE, Korn S, Corren J, Israel E, Chupp G, Bednarczyk A, Ponnarambil S, Caveney S, Almqvist G, Golabek M, Simonsson L, Lawson K, Bowen K, Colice G; DESTINATION study investigators. Long-term safety and efficacy of tezepelumab in people with severe, uncontrolled asthma (DESTINATION): a randomised, placebo-controlled extension study. Lancet Respir Med. 2023 May;11(5):425-438. doi: 10.1016/S2213-2600(22)00492-1. Epub 2023 Jan 23.
PMID: 36702146DERIVEDYin Z, Zhou Y, Turnquist HR, Liu Q. Neuro-epithelial-ILC2 crosstalk in barrier tissues. Trends Immunol. 2022 Nov;43(11):901-916. doi: 10.1016/j.it.2022.09.006. Epub 2022 Oct 14.
PMID: 36253275DERIVEDMenzies-Gow A, Corren J, Bourdin A, Chupp G, Israel E, Wechsler ME, Brightling CE, Griffiths JM, Hellqvist A, Bowen K, Kaur P, Almqvist G, Ponnarambil S, Colice G. Tezepelumab in Adults and Adolescents with Severe, Uncontrolled Asthma. N Engl J Med. 2021 May 13;384(19):1800-1809. doi: 10.1056/NEJMoa2034975.
PMID: 33979488DERIVEDMenzies-Gow A, Colice G, Griffiths JM, Almqvist G, Ponnarambil S, Kaur P, Ruberto G, Bowen K, Hellqvist A, Mo M, Garcia Gil E. NAVIGATOR: a phase 3 multicentre, randomized, double-blind, placebo-controlled, parallel-group trial to evaluate the efficacy and safety of tezepelumab in adults and adolescents with severe, uncontrolled asthma. Respir Res. 2020 Oct 13;21(1):266. doi: 10.1186/s12931-020-01526-6.
PMID: 33050934DERIVED
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MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Clinical Head
- Organization
- AstraZeneca
Study Officials
- PRINCIPAL INVESTIGATOR
Andrew Menzies-Gow, MD
Royal Brompton Hospital, United Kingdom
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Masking Details
- Double-Blind
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 9, 2017
First Posted
November 20, 2017
Study Start
November 23, 2017
Primary Completion
September 8, 2020
Study Completion
November 12, 2020
Last Updated
November 26, 2021
Results First Posted
November 26, 2021
Record last verified: 2021-10
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 Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.