Ig PRx in AECOPD: Pilot Study

Launched by OTTAWA HOSPITAL RESEARCH INSTITUTE · Feb 18, 2016

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Eligibility criteria

• 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