Tezepelumab COPD Exacerbation study
Research type
Research Study
Full 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)
IRAS ID
264808
Contact name
Dinesh Saralaya
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2019-001363-67
Duration of Study in the UK
2 years, 6 months, 6 days
Research summary
Research Summary
AstraZeneca is doing this research to find out if the experimental medication called tezepelumab will work and be safe as a medicine to treat moderate to very severe COPD. To do this, tezepelumab will be compared with placebo. The research study is planned to go on for 64 weeks and include around 282 patients globally.\n\nThe enrolment/run-in period will be approximately 6 weeks to allow adequate time for all the eligibility criteria to be evaluated. Subjects who meet the eligibility criteria will be randomized and have a 50% chance of receiving either tezepelumab or placebo. After randomization, subjects will be treated at monthly intervals for 48 weeks. The end-of-treatment (EOT) visit at week 52 will occur at 4 weeks after last treatment is administered. Two follow-up visits will then occur at Weeks 58 and 64. \n\nRandomized patients will undergo tests such as physical exams, vital signs, ECG, safety blood/urine samples and collection of exploratory blood/urine samples. They will also be asked to complete questionnaires, and undergo lung function and inflammation tests. Other tests which will be performed as a sub study for a subset of patients will include the collection of nasal lining cell, nasal lining fluid, and sputum samples.\n\nThe study is anticipated to continue until May 2022.\n
Summary of Results
https://www.trialsummaries.com/Study/StudyDetails?id=11089&tenant=MT_MED_9011
REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
19/YH/0230
Date of REC Opinion
5 Sep 2019
REC opinion
Further Information Favourable Opinion