Feasibility and Safety of Immunoglobulin (Ig) Treatment in COPD Outpatients With Frequent Exacerbations: Pilot Study 1
Status:
Completed
Trial end date:
2019-11-20
Target enrollment:
Participant gender:
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.