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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

Full criteria on ClinicalTrials.gov

Sites (83)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
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BurlingtonCanadaUnknown status
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CalgaryCanadaUnknown status
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HamiltonCanadaUnknown status
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MontrealCanadaUnknown status
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QuébecCanadaUnknown status
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Saint-Charles-BorroméeCanadaUnknown status
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Sherwood ParkCanadaUnknown status
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Trois-RivièresCanadaUnknown status
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TruroCanadaUnknown status
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VancouverCanadaUnknown status
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BerlinGermanyUnknown status
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FrankfurtGermanyUnknown status
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GroßhansdorfGermanyUnknown status
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LübeckGermanyUnknown status
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MainzGermanyUnknown status
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AalborgDenmarkUnknown status
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Aarhus NDenmarkUnknown status
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HvidovreDenmarkUnknown status
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København NVDenmarkUnknown status
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Odense CDenmarkUnknown status
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RoskildeDenmarkUnknown status
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VejleDenmarkUnknown status
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AlziraSpainUnknown status
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BarcelonaSpainUnknown status
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GranadaSpainUnknown status
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MálagaSpainUnknown status
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Mérida (Badajoz)SpainUnknown status
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AmiensFranceUnknown status
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BrestFranceUnknown status
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GrenobleFranceUnknown status
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LyonFranceUnknown status
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MarseilleFranceUnknown status
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MontpellierFranceUnknown status
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NantesFranceUnknown status
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BradfordUnited KingdomUnknown status
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ChertseyUnited KingdomUnknown status
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CottinghamUnited KingdomUnknown status
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GlasgowUnited KingdomUnknown status
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LondonUnited KingdomUnknown status
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Newcastle upon TyneUnited KingdomUnknown status
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WakefieldUnited KingdomUnknown status
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AshkelonIsraelUnknown status
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BeershebaIsraelUnknown status
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HaifaIsraelUnknown status
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JerusalemIsraelUnknown status
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Kfar SabaIsraelUnknown status
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RehovotIsraelUnknown status
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DaeguSouth KoreaUnknown status
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IncheonSouth KoreaUnknown status
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JeonjuSouth KoreaUnknown status
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SeoulSouth KoreaUnknown status
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Uijeongbu-siSouth KoreaUnknown status
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EindhovenNetherlandsUnknown status
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HeerlenNetherlandsUnknown status
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RotterdamNetherlandsUnknown status
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ZutphenNetherlandsUnknown status
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AbingdonUnited StatesUnknown status
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AlbuquerqueUnited StatesUnknown status
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BrandonUnited StatesUnknown status
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BuckleyUnited StatesUnknown status
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CharlotteUnited StatesUnknown status
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ColumbusUnited StatesUnknown status
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DothanUnited StatesUnknown status
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EdmondUnited StatesUnknown status
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EverettUnited StatesUnknown status
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Huntington BeachUnited StatesUnknown status
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McKinneyUnited StatesUnknown status
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MedfordUnited StatesUnknown status
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MooresvilleUnited StatesUnknown status
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Mt. PleasantUnited StatesUnknown status
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New BernUnited StatesUnknown status
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New HavenUnited StatesUnknown status
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Newport BeachUnited StatesUnknown status
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OrlandoUnited StatesUnknown status
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Panama CityUnited StatesUnknown status
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PhiladelphiaUnited StatesUnknown status
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PittsburghUnited StatesUnknown status
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Rapid CityUnited StatesUnknown status
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Rock HillUnited StatesUnknown status
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TampaUnited StatesUnknown status
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UplandUnited StatesUnknown status
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WestminsterUnited StatesUnknown status
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Winter ParkUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.