A Phase III, Multicentre, Randomised, Double-blind, Chronic-dosing, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy and Safety of Two Dose Regimens of Tozorakimab in Participants with Symptomatic Chronic Obstructive Pulmonary Disease (COPD) with a History of COPD Exacerbations (OBERON)
A Phase 3 study to evaluate the effectiveness and safety of a study drug, MEDI3506, in participants diagnosed with COPD and have a history of exacerbations.
This study will last for 60 weeks and require 16 in-person visits to the Hershey Medical Center. During those visits, various assessments will be performed including: collecting medical history and medication use, assessing smoking status, physical examinations, collecting height, weight and supplemental oxygen status, a chest CT or x-ray (if one from the past 6 months is not available), spirometry, evaluating COPD exacerbations, checking electronic questionnaire compliance, completing questionnaires (also at home between study visits), ECGs, vital signs, blood work and urine testing, collecting optional samples if you wish to take part, and administering the study drug.
Diagnosed with COPD for at least one year
Currently being treated with inhaled maintenance therapy
Active vaping of any products in the past 6 months
History of alcohol or drug abuse within the past year
History of known immunodeficiency
Receiving long-term oxygen at greater than 4 Liters per minute