Ig PRx in AECOPD: Pilot Study

This is an interventional other trial for Chronic Obstructive Pulmonary Disease focused on measuring AECOPD, COPD Read More

Inclusion Criteria:

• Hospitalized adult patient with AECOPD (clinically dominant AECOPD in the case of multiple co-morbidities eg. absence of overt lobar pneumonia or acute congestive heart failure or alternate diagnosis such as acute coronary syndrome or pulmonary embolism)
• Diagnosis of severe COPD (post bronchodilator FEV1 <50%, FEV1/FVC ratio <0.7) made by standard spirometry within previous 12 months or within three days of admission if previous PFT data is not available
• Age >40 years
• >10 pack year smoking history
• At least one COPD exacerbation in the previous 12 months before enrollment, defined by having had documented inpatient or outpatient treatment by physician with antibiotics and/or prednisone for physician diagnosed COPD exacerbation
• Expected to live > 12 months

Exclusion Criteria:

• Known severe hypersensitivity to immunoglobulin or its components (anaphylaxis)
• Underlying malignancy (including chronic lymphocytic leukemia)
• History of hematopoietic stem cell transplant or solid organ transplant
• Current treatment with a biological therapy for other conditions
• Concomitant significant immunodeficiency or on immunosuppressive treatment other than for COPD
• Alpha-1 antitrypsin deficiency
• Significant proteinuria (dipstick proteinuria ≥ 3+ or known urinary protein loss ≥ 2 g/day or nephrotic syndrome) and/or has acute renal failure and/or severe renal impairment (creatinine more than 2.5 times the upper limit of normal and/or on dialysis)
• IgA deficiency (IgA <0.1 g/L)
• Immunoglobulin therapy in the last 12 months or on current Ig therapy or have a clinical indication for Ig replacement therapy (www.nacblood.ca/resources/guidelines/IVIG.html)
• Obesity (BMI ≥35 kg/m²)
• Pregnancy