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

Sponsor

Rochester General Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05764993

Collaborator

Takeda (Industry)

Enrollment

Locations

Arms

Anticipated Duration (Months)

13.3

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
COPD Exacerbation Acute	Biological: CUVITRU - Ig subcutaneous human 20% Other: Standard Medical Therapy	Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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 patientsnon-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

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Apr 1, 2023

Anticipated Primary Completion Date :

Feb 28, 2025

Anticipated Study Completion Date :

Dec 30, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group #1 SCIgR with Cuvitru 125 mg/kg/week + standard of care management	Biological: CUVITRU - Ig subcutaneous human 20% Subcutaneous Immunoglobin Replacement Therapy, SCigR Other Names: Immune Globulin Subcutaneous (Human), 20% Solution Other: Standard Medical Therapy Standard Medical Therapy
Placebo Comparator: Group #2 Standard of care management = 20 patients	Other: Standard Medical Therapy Standard Medical Therapy

Arm

Intervention/Treatment

Experimental: Group #1

SCIgR with Cuvitru 125 mg/kg/week + standard of care management

Biological: CUVITRU - Ig subcutaneous human 20%

Subcutaneous Immunoglobin Replacement Therapy, SCigR

Other Names:

Immune Globulin Subcutaneous (Human), 20% Solution

Other: Standard Medical Therapy

Standard Medical Therapy

Placebo Comparator: Group #2

Standard of care management = 20 patients

Other: Standard Medical Therapy

Standard Medical Therapy

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients > 18 years old.
≥ 10 pack years of tobacco use
Established diagnosis of COPD with PFTs showing FEV1/FVC < 70% or FEV1/VC ratio below the 5th percentile of the predicted value.[14]
Adherence with triple therapy [Inhaled Corticosteroid (ICS), Long-acting beta2-adrenergic agonist (LABA), Long-acting muscarinic antagonist (LAMA)]
≥ 2 steroid-requiring exacerbations (defined by increased respiratory symptoms of increased cough, dyspnea, sputum, sputum purulence, wheeze, chest tightness) requiring treatment with systemic steroids within the past 12 months OR one exacerbation requiring inpatient hospitalization
Medically stable
Expected life expectancy > 1 year
Ability to sign informed consent

Exclusion Criteria:

Known history of humoral dysfunction/immunodeficiency
Additional immunosuppressive states as per the investigator
Ongoing or recent therapy with immunoglobulin replacement therapy within the past 6 months
Chronic oral steroid use of prednisone 20 mg daily (or equivalent)
Alpha-1 antitrypsin deficiency

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rochester Regional Health Ctr for Clinical Research - Alexander Park	Rochester	New York	United States	14607
2	Rochester Regional Health - Ctr for Clinical Research - Linden Oaks	Rochester	New York	United States	14625
3	Rochester Regional Health - Ctr for Clinical Research - Greece	Rochester	New York	United States	14626