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Phase IIA

Tezepelumab COPD Exacerbation Study (COURSE)

  • Study HIC#:2000026323
  • Last Updated:07/15/2021

To evaluate the effect of tezepelumab as compared with placebo on COPD exacerbations in subjects with moderate to very severe COPD

  • Age40 years - 80 years
  • GenderBoth
  • Start Date01/08/2020
  • End Date02/14/2022

Trial Purpose and Description

To evaluate the effect of tezepelumab as compared with placebo on COPD exacerbations in subjects with moderate to very severe COPD

Eligibility Criteria

Inclusion Criteria:

  1. 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.
  2. History of at least 2 documented moderate to severe COPD exacerbations within 2 to 52 weeks prior to enrollment.
  3. CAT score of ≥15 at enrollment and on day of randomization.
  4. 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.
  5. Chest x-ray, CT scan or MRI scan of the chest/lungs must not show suspected lung pathology that prevents the patient's ability to complete the study.

Exclusion Criteria:

  1. Clinically important pulmonary disease other than COPD, as judged by the Investigator (including current or historic asthma diagnosis).
  2. 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.
  3. Major surgery within 8 weeks before enrollment.
  4. History of clinically significant infection requiring antibiotics or antiviral medication within 14 days before enrollment.
  5. Pregnant or breastfeeding.

Sub-Investigators

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