Feasibility and Safety of Immunoglobulin (Ig) Treatment in COPD Outpatients With Frequent Exacerbations: Pilot Study 1

Summary

Chronic obstructive pulmonary disease (COPD) is a progressive inflammatory disease of the airways, associated with poor health status, functional disability, significant morbidity, and increased risk of death. In Ontario, COPD is the leading cause of hospital admission and readmission, and costs the health system approximately 3 billion dollars annually. Individuals with COPD experience increased 'flare-up's' (acute exacerbations) as their disease worsens, characterized by periods of increased shortness of breath, cough, phlegm production, and weakness. Acute exacerbations of COPD (AECOPD) are most commonly caused by viral or bacterial infections, and often require patients to seek attention at the emergency room or hospital for treatment. Current treatments to prevent COPD exacerbations are only modestly effective. New therapies are needed to improve the quality of life and clinical outcomes for individuals living with COPD. Previous research at our center has shown a favourable effect of an antibody treatment (immunoglobulin) on the frequency of AECOPD, doctor visits, treatments, and hospitalizations for COPD patients. However, rigorous studies with more patients are required to confirm this effect. The investigators propose a clinical trial to evaluate immunoglobulin treatment in outpatients with frequent exacerbations. In this study the investigators will determine if immunoglobulin treatment is feasible, safe, tolerable, and potentially effective in reducing the frequency of acute exacerbations. If this study is feasible and potentially effective, it will inform larger studies to confirm the therapeutic effect of immunoglobulin treatment, and would be a major advance in care of COPD.

Timeline

Start

2018-03-11

Primary completion

2019-11-20

Completion

2019-11-20

Publications

• Cowan J, Mulpuru S, Abdallah SJ, Chopra A, Purssell A, McGuinty M, Alvarez GG, Giulivi A, Corrales-Medina V, MacFadden D, Boyle L, Hasimja D, Thavorn K, Mallick R, Aaron SD, Cameron DW. A Randomized Double-Blind Placebo-Control Feasibility Trial of Immunoglobulin Treatment for Prevention of Recurrent Acute Exacerbations of COPD. Int J Chron Obstruct Pulmon Dis. 2021 Dec 3;16:3275-3284. doi: 10.2147/COPD.S338849. eCollection 2021.
• Cowan J, Mulpuru S, Aaron S, Alvarez G, Giulivi A, Corrales-Medina V, Thiruganasambandamoorthy V, Thavorn K, Mallick R, Cameron DW. Study protocol: a randomized, double-blind, parallel, two-arm, placebo control trial investigating the feasibility and safety of immunoglobulin treatment in COPD patients for prevention of frequent recurrent exacerbations. Pilot Feasibility Stud. 2018 Aug 11;4:135. doi: 10.1186/s40814-018-0327-z. eCollection 2018.

Drugs

Indications