Evaluating the safety and efficacy of a new biologic targeted therapy versus placebo, as add-on to standard treatment, in adults with chronic obstructive pulmonary disease (COPD) with symptoms and a history of exacerbations

Overview

Chronic obstructive pulmonary disease (COPD) is a progressive, irreversible chronic respiratory disease characterized by persistent airway inflammation, chronic symptoms, and reduced quality of life. Even with optimized inhaled therapy, many patients continue to experience moderate or severe exacerbations, increasing the risk of hospitalization and death. This study aims to evaluate the efficacy of a targeted biologic therapy that inhibits interleukin-33 (IL-33), with the expectation of better controlling exacerbations, improving symptoms and lung function, and thereby enhancing treatment outcomes and prolonging survival in COPD patients.

Inclusion Criteria

Men and women aged ≥40 years
Diagnosis of COPD for at least 1 year, on stable background dual or triple therapy (ICS/LABA/LAMA)
History of ≥2 moderate COPD exacerbations or ≥1 severe exacerbation in the last 12 months, with at least one treated with systemic corticosteroids
Smoking history ≥10 pack-years

Exclusion Criteria

Other significant pulmonary diseases besides COPD such as active tuberculosis, pulmonary fibrosis, severe bronchiectasis, cystic fibrosis, or α1-antitrypsin deficiency
History of, or current, asthma or asthma–COPD overlap syndrome
HIV infection or hepatitis B or C (except cured hepatitis C)
Any other unstable disorder that would interfere with study adherence or participant safety

PI

Assoc. Prof, MD Nguyễn Văn Đĩnh – Clinical Allergy–Immunology Center, Vinmec Times City Internation Hospital

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