Ig PRx in AECOPD: Pilot Study

Ottawa Hospital Research Institute

Status and phase: Completed; Phase 2

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Drug: Normal Saline; Drug: Intravenous immunoglobulin (IVIG)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02690038

20150925 / 20160077-01H

Details and patient eligibility

About

This study will look at immunoglobulin (Ig) treatment in hospitalized chronic obstructive lung disease (COPD) patients with frequent exacerbations.

This is a Phase II, pilot randomized double blind control study, meaning this study will help assess if this research can be expanded to evaluate Ig treatment in patients with COPD. Ig treatment is a sterile solution of human immunoglobulin proteins given intravenously (in the vein). Immunoglobulins are part of the immune system and help the body fight infections. Participants will be assigned to either receiving the Ig treatment or normal saline as a control product every 4 weeks for 12 months.

Participants will continue on current standard therapy as determined by their treating physician.

Enrollment: 48 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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48 participants in 2 patient groups

Intervention Arm 1: Treatment

Experimental group

Description:

Baseline Ig \< 7g/L group - Intravenous immunoglobulin (IVIG) 0.8 g/kg will be given within 12 hours after randomization during hospital admission and then every 4 weeks for 44 weeks (total 48 weeks). Baseline Ig \> or = 7 g/L group - Intravenous immunoglobulin (IVIG) 0.5 g/kg will be given within 12 hours after randomization during hospital admission and then every 4 weeks for 44 weeks (total 48 weeks).

Treatment:

Drug: Intravenous immunoglobulin (IVIG)

Intervention Arm 2: Control

Active Comparator group

Description:

Baseline Ig \< 7g/L group - Normal Saline (0.9% NaCl) 8 mL/kg will be given within 12 hours after randomization during hospital admission and then every 4 weeks for 44 weeks (total 48 weeks). Baseline Ig \> or = 7 g/L group - Normal Saline (0.9% NaCl) 5 mL/kg will be given within 12 hours after randomization during hospital admission and then every 4 weeks for 44 weeks (total 48 weeks).

Treatment:

Drug: Normal Saline