Effects of Blocking TSLP on Airway Inflammation and the Epithelial Immune-response to Exacerbation Triggers in Patients With COPD A Randomized Double-blind, Placebo-controlled Trial of Tezepelumab UPSTREAM-COPD
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.
• 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 a responsible physician. Periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception. Females of childbearing potential are defined as those who are not surgically sterile (ie, bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy) or postmenopausal (defined as 12 months with no menses without an alternative medical cause).