Summary

Eligibility
for people ages 40-80 (full criteria)
Location
at Sacramento, California and other locations
Dates
study started
estimated completion

Description

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)

Official Title

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)

Details

This is a Phase 2a, multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety and efficacy of tezepelumab in adults with moderate to very severe chronic obstructive pulmonary disease (COPD) receiving triple inhaled maintenance therapy, and having had 2 or more documented COPD exacerbations in the 12 months prior to Visit 1. Approximately, 282 subjects will be randomized globally. Subjects will be stratified by region and prior number of exacerbations (2 vs. 3 or more). Subjects will receive tezepelumab, or placebo, administered via subcutaneous injection at the study site, over a 52 week treatment period. The study also includes a post-treatment follow-up period of 12 weeks.

Keywords

Chronic Obstructive Pulmonary Disease (COPD) COPD Moderate COPD Severe COPD chronic obstructive pulmonary disease Pulmonary Disease, Chronic Obstructive Lung Diseases Lung Diseases, Obstructive Tezepelumab

Eligibility

You can join if…

Open to people ages 40-80

  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.

You CAN'T join if...

  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.
  6. The chest/lungs with pathology that precludes the patient's ability to complete the study
  7. The patient has active COVID 19 infection during screening period.

Locations

  • Research Site
    Sacramento California 95817 United States
  • Research Site
    Medford Oregon 97504 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AstraZeneca
Links
Sign up for this study
ID
NCT04039113
Phase
Phase 2
Study Type
Interventional
Last Updated