NCT04039113CompletedPhase 2
Tezepelumab COPD Exacerbation Study
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)
Source: ClinicalTrials.gov · Last updated 18 Feb 2025
Brief summary (registry, in English)
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)
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 337 (actual)
- First submitted
- 29 Jul 2019
- Start date
- 30 Jul 2019
- Primary completion date
- 10 Nov 2023
- Lead sponsor
- AstraZeneca
- Diseases
- COPD
- NCT number
- NCT04039113
- EudraCT number
- 2019-001363-67
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 337
- From 30 Jul 2019 to the primary completion date, 10 Nov 2023
- 83 sites in 10 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Major surgery within 8 weeks before enrollment.
- History of clinically significant infection requiring antibiotics or antiviral medication within 14 days before enrollment.
Other illness
- 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.
- The patient has active COVID 19 infection during screening period.
Other
- Pregnant or breastfeeding.
- The chest/lungs with pathology that precludes the patient's ability to complete the study
Who the study is looking for
- 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.
Age in the registry: 40 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (83)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Research Site Coordinator of this site? Confirm its status | Burlington | Canada | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Calgary | Canada | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Hamilton | Canada | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Québec | Canada | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Saint-Charles-Borromée | Canada | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Sherwood Park | Canada | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Trois-Rivières | Canada | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Truro | Canada | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Vancouver | Canada | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Berlin | Germany | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Frankfurt | Germany | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Großhansdorf | Germany | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Lübeck | Germany | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Mainz | Germany | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Aalborg | Denmark | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Aarhus N | Denmark | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Hvidovre | Denmark | Unknown status |
| Research Site Coordinator of this site? Confirm its status | København NV | Denmark | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Odense C | Denmark | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Roskilde | Denmark | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Vejle | Denmark | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Alzira | Spain | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Granada | Spain | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Málaga | Spain | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Mérida (Badajoz) | Spain | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Amiens | France | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Brest | France | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Grenoble | France | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Lyon | France | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Marseille | France | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Montpellier | France | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Nantes | France | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Bradford | United Kingdom | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Chertsey | United Kingdom | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Cottingham | United Kingdom | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Glasgow | United Kingdom | Unknown status |
| Research Site Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Newcastle upon Tyne | United Kingdom | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Wakefield | United Kingdom | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Ashkelon | Israel | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Beersheba | Israel | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Haifa | Israel | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Jerusalem | Israel | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Kfar Saba | Israel | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Rehovot | Israel | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Daegu | South Korea | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Incheon | South Korea | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Jeonju | South Korea | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Uijeongbu-si | South Korea | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Eindhoven | Netherlands | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Heerlen | Netherlands | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Zutphen | Netherlands | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Abingdon | United States | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Albuquerque | United States | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Brandon | United States | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Buckley | United States | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Charlotte | United States | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Dothan | United States | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Edmond | United States | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Everett | United States | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Huntington Beach | United States | Unknown status |
| Research Site Coordinator of this site? Confirm its status | McKinney | United States | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Medford | United States | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Mooresville | United States | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Mt. Pleasant | United States | Unknown status |
| Research Site Coordinator of this site? Confirm its status | New Bern | United States | Unknown status |
| Research Site Coordinator of this site? Confirm its status | New Haven | United States | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Newport Beach | United States | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Orlando | United States | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Panama City | United States | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Rapid City | United States | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Rock Hill | United States | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Upland | United States | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Westminster | United States | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Winter Park | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.