Effects of Blocking TSLP on Airway Inflammation and the Epithelial Immune-response to Exacerbation Triggers in Patients With COPD
Trial Parameters
Brief Summary
A phase 2, multicentre, randomized, double-blind, placebo-controlled, parallel group study to evaluate the effect of tezepelumab on airway inflammation in patients with COPD.
Eligibility Criteria
Inclusion Criteria: * Written informed consent * A diagnosis of COPD (according to GOLD (GOLD 2021 Report)) * ≥ 10 packyears smoked (current or ex-smokers) * Age 40 years or older * Postbronchodilator FEV1 ≥ 30% predicted (and ≥ 1.0L) and \< 80% predicted * Maintenance treatment with LAMA+LABA±ICS (stable dose) for at least 3 months prior to V1 * ≥1 prednisolon and/or antibiotic treated exacerbation in the past 12 months * Subjects must demonstrate acceptable inhaler and spirometry techniques during screening (as evaluated and in the opinion of study site staff) * Subjects must demonstrate ≥ 70% compliance with daily inhalers during the screening/run-in * Females of childbearing potential who are sexually active with a nonsterilized male partner must use a highly effective method of contraception from the time informed consent is obtained and must agree to continue using such precautions through Week 20 of the study; cessation of contraception after this point should be discussed with