NCT02690038

Ig PRx in AECOPD: Pilot Study

Feasibility and Safety of Immunoglobulin (Ig) Prophylactic Treatment in COPD Patients With Frequent Exacerbations: A Pilot Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Ottawa Hospital Research Institute · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Chronic Obstructive Pulmonary Disease

Interventions

Type	Name	Description
DRUG	Intravenous immunoglobulin (IVIG)	Baseline Ig \< 7g/L group - Intravenous immunoglobulin (IVIG) 0.8 g/kg will be given within 12 hours after randomization. Baseline Ig \> or = 7 g/L group - Intravenous immunoglobulin (IVIG) 0.5 g/kg will be given within 12 hours after randomization
DRUG	Normal Saline	Baseline Ig \< 7g/L group - Normal Saline (0.9% NaCl) 8 mL/kg will be given within 12 hours after randomization. Baseline Ig \> or = 7 g/L group - Normal Saline (0.9% NaCl) 5 mL/kg will be given within 12 hours after randomization

Timeline

• Start date: 2016-09-01
• Primary completion: 2019-11-20
• Completion: 2019-11-20
• First posted: 2016-02-24
• Last updated: 2019-11-27

Locations

1 site across 1 country: Canada