Tezepelumab COPD Exacerbation Study
COURSE
A Randomized, Double-blind, Placebo-controlled, Parallel Group, Multicenter Phase 2a Study to Explore the Efficacy and Safety of Tezepelumab in Patients With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) (COURSE)
2 other identifiers
interventional
337
10 countries
91
Brief Summary
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 2a Study to Explore the Efficacy and Safety of Tezepelumab in Adults with Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2019
Typical duration for phase_2
91 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
July 29, 2019
CompletedStudy Start
First participant enrolled
July 30, 2019
CompletedFirst Posted
Study publicly available on registry
July 31, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 10, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2024
CompletedResults Posted
Study results publicly available
February 18, 2025
CompletedFebruary 18, 2025
February 1, 2025
4.3 years
July 29, 2019
November 8, 2024
February 17, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate of Moderate or Severe COPD Exacerbations in Participants With Moderate to Very Severe COPD.
A COPD exacerbation was defined as a change in the participant's usual COPD symptoms that is beyond normal day-to-day variation, is acute in onset, lasts 2 or more days, and may warrant a change in regular medication and leads to any of the following: Use of systemic corticosteroids for at least 3 days, use of antibiotics for at least 3 days, an inpatient hospitalisation due to COPD, or results in death. Analysis was done using a negative binomial model with the response variable as the number of COPD exacerbations experienced during the follow-up for exacerbations. The model included covariates of treatment group, region, and number of exacerbations reported at randomisation as recorded in IWRS (2, \>=3). The logarithm of the time at risk (in years) for exacerbation in the study is used as an offset variable.
From randomisation up to Week 52
Secondary Outcomes (11)
Time to First Moderate/Severe COPD Exacerbation
From randomisation up to Week 52
Proportion of Participants COPD Exacerbation Free at Week 52
From randomisation up to Week 52
Comparison of Annual Severe COPD Exacerbation Rates Over 52 Weeks
From randomisation up to Week 52
Proportion of Participants With >=1 Severe COPD Exacerbations Over 52 Weeks
From randomisation up to Week 52
Time to First Severe COPD Exacerbation
From randomisation up to Week 52
- +6 more secondary outcomes
Study Arms (2)
Tezepelumab
ACTIVE COMPARATORTezepelumab, SC, Q4W
Matching Placebo
PLACEBO COMPARATORMatching placebo, SC, Q4W
Interventions
Eligibility Criteria
You may qualify if:
- History of moderate to very severe physician-diagnosed COPD for at least 12 months prior to enrolment with a post-bronchodilator FEV1/FVC\<0.70 and a post-bronchodilator FEV1 ≥20% and ≤80% of predicted normal value.
- History of at least 2 documented moderate to severe COPD exacerbations within 2 to 52 weeks prior to enrollment.
- CAT score of ≥15 at enrollment and on day of randomization.
- Documented treatment with triple therapy for COPD (medium or high dose ICS/LABA/LAMA) throughout the year prior to enrollment. The dose of ICS should be stable for 3 months prior to enrollment.
You may not qualify if:
- Clinically important pulmonary disease other than COPD, as judged by the Investigator (including current or historic asthma diagnosis).
- Any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious (including risk factors for pneumonia), endocrine, metabolic, hematological, psychiatric, or major physical impairment that is not stable.
- Major surgery within 8 weeks before enrollment.
- History of clinically significant infection requiring antibiotics or antiviral medication within 14 days before enrollment.
- Pregnant or breastfeeding.
- The chest/lungs with pathology that precludes the patient's ability to complete the study
- The patient has active COVID 19 infection during screening period.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- Amgencollaborator
Study Sites (91)
Research Site
Dothan, Alabama, 36305, United States
Research Site
Huntington Beach, California, 92647, United States
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Newport Beach, California, 92663, United States
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Upland, California, 91786, United States
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Westminster, California, 92683, United States
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New Haven, Connecticut, 06510, United States
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Brandon, Florida, 33511, United States
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Orlando, Florida, 32819, United States
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Panama City, Florida, 32405, United States
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Tampa, Florida, 33607, United States
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Winter Park, Florida, 32789-4681, United States
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Buckley, Michigan, 49620, United States
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Albuquerque, New Mexico, 87108, United States
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Charlotte, North Carolina, 28277, United States
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Mooresville, North Carolina, 28117, United States
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New Bern, North Carolina, 28562, United States
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Columbus, Ohio, 43215, United States
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Edmond, Oklahoma, 73034, United States
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Medford, Oregon, 97504, United States
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Philadelphia, Pennsylvania, 19140, United States
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Pittsburgh, Pennsylvania, 15213, United States
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Mt. Pleasant, South Carolina, 29464, United States
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Rock Hill, South Carolina, 29732, United States
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Rapid City, South Dakota, 57702, United States
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McKinney, Texas, 75069, United States
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Abingdon, Virginia, 24210, United States
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Everett, Washington, 98208, United States
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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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Truro, Nova Scotia, B2N 1L2, Canada
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Burlington, Ontario, L7N 3V2, Canada
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Hamilton, Ontario, L8N 3Z5, Canada
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Montreal, Quebec, H1M 1B1, Canada
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Québec, Quebec, G1V 4G5, Canada
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Québec, Quebec, G3K 2P8, 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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Aalborg, 9000, Denmark
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Aarhus N, 8200, Denmark
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Hvidovre, 2650, Denmark
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København NV, 2400, Denmark
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Odense C, 5000, Denmark
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Roskilde, 4000, Denmark
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Vejle, 7100, Denmark
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Amiens, 80054, France
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Brest, 29609, France
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Grenoble, 38043, France
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Lyon, 69317, France
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Marseille, 13015, France
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Montpellier, 34090, France
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Nantes, 44093, France
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Berlin, 12203, Germany
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Frankfurt, 60596, Germany
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Großhansdorf, 20927, 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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Beersheba, 84101, 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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Eindhoven, 5623 EJ, Netherlands
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Heerlen, 6419 PC, Netherlands
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Rotterdam, 3045 PM, Netherlands
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Rotterdam, 3083 AN, Netherlands
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Zutphen, 7207 AE, Netherlands
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Daegu, 42415, South Korea
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Incheon, 21431, South Korea
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Jeonju, 54907, South Korea
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Seoul, 03312, South Korea
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Seoul, 03722, South Korea
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Seoul, 05030, South Korea
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Seoul, 05505, South Korea
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Seoul, 06591, South Korea
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Seoul, 06973, South Korea
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Uijeongbu-si, 11765, South Korea
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Alzira, 46410, Spain
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Barcelona, 08025, Spain
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Granada, 18014, Spain
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Málaga, 29010, Spain
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Mérida (Badajoz), 06800, Spain
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Bradford, BND9 6RJ, United Kingdom
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Chertsey, KT16 0PZ, United Kingdom
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Cottingham, HU16 5JQ, United Kingdom
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Glasgow, G12 0YN, United Kingdom
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London, SW10 9NH, United Kingdom
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Newcastle upon Tyne, NE1 4LP, United Kingdom
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Wakefield, WF1 4DG, United Kingdom
Related Publications (1)
Singh D, Brightling CE, Rabe KF, Han MK, Christenson SA, Drummond MB, Papi A, Pavord ID, Molfino NA, Almqvist G, Kotalik A, Hellqvist A, Golabek M, Sindhwani NS, Ponnarambil SS; COURSE study investigators. Efficacy and safety of tezepelumab versus placebo in adults with moderate to very severe chronic obstructive pulmonary disease (COURSE): a randomised, placebo-controlled, phase 2a trial. Lancet Respir Med. 2025 Jan;13(1):47-58. doi: 10.1016/S2213-2600(24)00324-2. Epub 2024 Dec 6.
PMID: 39653044DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Clinical Lead
- Organization
- AstraZeneca
Study Officials
- PRINCIPAL INVESTIGATOR
Dave Singh, MD
Division of Infection, Immunity & Resp Medicine, The University of Manchester, United Kingdom
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Double-blinded
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 29, 2019
First Posted
July 31, 2019
Study Start
July 30, 2019
Primary Completion
November 10, 2023
Study Completion
January 31, 2024
Last Updated
February 18, 2025
Results First Posted
February 18, 2025
Record last verified: 2025-02