Abstract
BackgroundChronic obstructive pulmonary disease (COPD) is a chronic progressive inflammatory disease of the airways, associated with frailty, disability, co-morbidity, and mortality. Individuals with COPD experience increased risk and rates of acute exacerbation as their lung disease worsens. Current treatments to prevent acute exacerbation of COPD (AECOPD) are only modestly effective. New therapies are needed to improve the quality of life and clinical outcomes for individuals living with COPD and especially for those prone to frequent recurrent AECOPD. Recent research has suggested an association of gammaglobulin or immunoglobulin G levels with AECOPD and a favorable effect of an immunoglobulin treatment on the frequency of recurrent AECOPD, healthcare provider visits, treatments, and hospitalizations. However, control trials are required to confirm this apparent association and therapeutic effect. This study aims to assess if intravenous immunoglobulin (IVIG) therapy is feasible, safe, tolerable, and potentially effective in reducing the frequency of recurrent AECOPD.Methods/designAdult COPD patients at The Ottawa Hospital (TOH) will be recruited to partake in a randomized double-blind, parallel, two-arm, placebo control trial. Eligible patients will be administered either IVIG or normal saline following 1:1 randomization and every 4 weeks for 1 year. The primary outcome of feasibility will be determined by recruitment, patient adherence, safety and tolerance, success of the follow-up procedures, and outcome measurement. The safety and tolerability will be assessed through adverse events, adherence, and study withdrawals. Efficacy trends will be investigated by assessing incidence rates of AECOPD, improvement in quality of life, and healthcare services use and cost.DiscussionThe study results will inform larger studies designed to confirm a clinically significant therapeutic effect in identifiable populations which would be a major advance in the care of COPD patients.Trial registration numberClinicalTrial.gov, NCT03018652 and NCT02690038.
Highlights
Chronic obstructive pulmonary disease (COPD) is a chronic progressive inflammatory disease of the airways, associated with frailty, disability, co-morbidity, and mortality
The study results will inform larger studies designed to confirm a clinically significant therapeutic effect in identifiable populations which would be a major advance in the care of COPD patients
acute exacerbation of COPD (AECOPD) likely increases the progression of COPD, and it is likely that the inflammatory milieu created by AECOPD increases susceptibility to additional, recurrent AECOPD [4]
Summary
Chronic obstructive pulmonary disease (COPD) is a chronic progressive inflammatory disease of the airways, associated with frailty, disability, co-morbidity, and mortality. Individuals with COPD experience increased risk and rates of acute exacerbation as their lung disease worsens. Current treatments to prevent acute exacerbation of COPD (AECOPD) are only modestly effective. Chronic obstructive pulmonary disease (COPD) is a chronic respiratory disease characterized by a progressive decline in lung function, shortness of breath, exercise limitation, poor health status, and increased mortality. Patients with COPD experience episodic flares of their disease. These acute exacerbations of COPD (AECOPD) are characterized by increased cough, shortness of breath, sputum production, weakness, and worsening airflow obstruction [3]. AECOPD likely increases the progression of COPD, and it is likely that the inflammatory milieu created by AECOPD increases susceptibility to additional, recurrent AECOPD [4]
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