Phase 2 Study of Tezepelumab Injections to Reduce Airway Inflammation in COPD Patients Using LABA and LAMA Treatments

What this Trial Is About

Researchers are evaluating the effect of tezepelumab on airway inflammation in patients with chronic obstructive pulmonary disease COPD who have experienced at least one exacerbation in the past year. This phase 2, multicenter, randomized, double-blind, placebo-controlled study focuses on patients already using maintenance treatments like LABA and LAMA, with or without ICS. The study aims to understand how blocking TSLP impacts inflammation and the immune response in the airways of people with COPD. Participants will be randomly assigned to receive either tezepelumab or a placebo through subcutaneous injections at the study site. The treatment period lasts 20 weeks, with five doses administered at four-week intervals. The study includes two groups one receiving tezepelumab 210 mg and the other receiving placebo injections, both under blinded conditions to ensure unbiased results. During the study, researchers will assess airway inflammation through tissue analysis focusing on specific immune cells such as eosinophils, neutrophils, mast cells, CD4 and CD8 cells, and macrophages. Participants will undergo evaluations including lung function tests and monitoring of inhaler use. Safety and treatment effects will be closely observed throughout the 20-week period. The study aims to provide detailed insights into how tezepelumab influences airway inflammation in COPD.

Effects of Blocking TSLP on Airway Inflammation and the Epithelial Immune-response to Exacerbation Triggers in Patients With COPD