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

Phase 2

Recruiting

• Conditions: COPD Exacerbation Acute
• Interventions: Biological: CUVITRU - Ig subcutaneous human 20%; Other: Standard Medical Therapy

• Registration Number: NCT05764993
• Lead Sponsor: Rochester General Hospital

Brief 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

Study Timeline

• Study First Submitted: 2022-11-29
• Study First Submitted QC: 2023-02-28
• Study First Posted: 2023-03-13
• Status Verified: 2023-06
• Study Start: 2023-06-01
• Last Update Submitted: 2023-06-13
• Last Update Posted: 2023-06-15
• Primary Completion: 2025-02-28
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group #1	Standard Medical Therapy	SCIgR with Cuvitru 125 mg/kg/week + standard of care management
Group #1	CUVITRU - Ig subcutaneous human 20%	SCIgR with Cuvitru 125 mg/kg/week + standard of care management
Group #2	Standard Medical Therapy	Standard of care management = 20 patients

Primary Outcome Measures

Name	Time	Method
AECOPD requiring treatment with systemic steroids over one year	one year	AECOPD is defined by increased respiratory symptoms (e.g., cough, dyspnea, sputum, sputum purulence, wheeze, chest tightness) requiring treatment with systemic steroids.

Secondary Outcome Measures

Name	Time	Method
COPD with pre-defined humoral dysfunction treated with subcutaneous SCIgR will have decreased AECOPD events as compared to COPD with pre-defined humoral dysfunction treated with the standard of care (SOC) management.	one year	AECOPD events will be determined by evaluating the rate of re-hospitalization in both treatment groups (ie with subcutaneous SCIgR + SOC versus SOC). The treatment group with subcutaneous SCIgR + SOC will have decreased AECOPD events as evidenced by the lower rehospitalization rate in comparison to the SOC treatment group's rehospitalization rate.

Trial Locations

Locations (3)

Rochester Regional Health Ctr for Clinical Research - Alexander Park; 🇺🇸 Rochester, New York, United States

Rochester Regional Health - Ctr for Clinical Research - Linden Oaks; 🇺🇸 Rochester, New York, United States

Rochester Regional Health - Ctr for Clinical Research - Greece; 🇺🇸 Rochester, New York, United States