NCT05764993

Prevalence of Humoral Dysfunction in Pts With Frequent Exacerbations of COPD, and the Effect of SCIgR for Prevention

Prevalence of Humoral Immune Deficiency in Patients With Frequent Exacerbations of COPD, and the Effect of Immunoglobulin Replacement on Future Exacerbations

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Rochester General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 82 Years
• Healthy volunteers: Not accepted

Summary

To examine the prevalence of humoral immunodeficiency in patients with Chronic Obstructive Pulmonary disease (COPD) by evaluating both immunoglobulin levels and vaccine responses. Patients with COPD and humoral dysfunction will be offered treatment with Subcutaneous Immune Globulin Replacement Therapy (SCIgR) in an attempt to decrease future AECOPD.

Detailed description

This will be a non-blinded, randomized study. Patients with COPD will be referred for evaluation by outpatient pulmonary clinics at Rochester Regional health. Following informed consent all patients will be evaluated by checking serum IgG, IgM, and IgA, as well as baseline and post-vaccine IgG to peptides antigens (diphtheria and tetanus) with Td as well as polysaccharide antigens (streptococcus pneumoniae) with pneumococcus polyvalent vaccine-23 (PPV23). Patients with COPD and pre-defined humoral dysfunction (please see below) will be randomized in 1:1 ratio to one of two groups until approximately 20 patients per group are accrued for a total of 40 patients Group #1: SCIgR with Cuvitru 125 mg/kg/week + standard of care management = 20 patients Group #2: Standard of care management = 20 patients

Conditions

• COPD Exacerbation Acute

Interventions

Type	Name	Description
BIOLOGICAL	CUVITRU - Ig subcutaneous human 20%	Subcutaneous Immunoglobin Replacement Therapy, SCigR
OTHER	Standard Medical Therapy	Standard Medical Therapy

Timeline

• Start date: 2023-06-01
• Primary completion: 2025-02-28
• Completion: 2025-12-30
• First posted: 2023-03-13
• Last updated: 2023-06-15

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study