Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Ottawa Hospital Research Institute
With
CSL Behring
Grifols Biologicals, LLC
Age
40–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
Known severe hypersensitivity to immunoglobulin or its components (anaphylaxis)
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)
