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

June 13, 2023 updated by: S. Shahzad Mustafa, Rochester General Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • New York
      • Rochester, New York, United States, 14607
        • Recruiting
        • Rochester Regional Health Ctr for Clinical Research - Alexander Park
        • Contact:
        • Contact:
        • Principal Investigator:
          • Syed S Mustafa, MD
        • Sub-Investigator:
          • Allison Ramsey, MD
        • Sub-Investigator:
          • Anne M Holly, PA
        • Sub-Investigator:
          • Sara Keller, PA
      • Rochester, New York, United States, 14625
        • Recruiting
        • Rochester Regional Health - Ctr for Clinical Research - Linden Oaks
        • Contact:
        • Contact:
        • Principal Investigator:
          • Syed S Mustafa, MD
        • Sub-Investigator:
          • Allison Ramsey, MD
        • Sub-Investigator:
          • Anne M Holly, PA
        • Sub-Investigator:
          • Sara Keller, PA
      • Rochester, New York, United States, 14626
        • Recruiting
        • Rochester Regional Health - Ctr for Clinical Research - Greece
        • Contact:
        • Contact:
        • Principal Investigator:
          • Syed S Mustafa, MD
        • Sub-Investigator:
          • Allison Ramsey, MD
        • Sub-Investigator:
          • Anne M Holly, PA
        • Sub-Investigator:
          • Sara Keller, PA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion criteria:

  1. Patients > 18 years and ≤ 82 years old.

  2. Patient that meet three (3) or more of the five (5) following criteria.

    1. Dyspnea ≥ 5 on a visual analog scale
    2. Respiratory rate ≥ 24 breaths per minute
    3. Heart rate ≥ 95 beats per minute
    4. Resting SaO2 < 92% breathing ambient air of the patient's usual oxygen prescription and/or change in saturation > 3% from baseline
    5. CRP ≥ 10 mg/L
  3. Established diagnosis of COPD with PFTs showing FEV1/FVC < 70% or FEV1/VC ratio below the 5th percentile of the predicted value.[14]
  4. Subjects must have adherence with triple therapy [Inhaled Corticosteroid (ICS), Long-acting beta2-adrenergic agonist (LABA), Long-acting muscarinic antagonist (LAMA)] for greater than 90 Days prior to consideration of participation in this study.
  5. With triple therapy onboard, the subject must have ≥ 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
  6. Medically stable with no acute hospitalizations for non-COPD related events within the last 3 months
  7. Expected life expectancy > 1 year
  8. Stable Cardiovascular Disease, with no planned intervention
  9. No history of pulmonary embolism or embolic event
  10. Hepatic function < Class B Child-Pugh criteria
  11. Renal insufficiency with eGFR > 60 mL/min/1.73m2
  12. No history of DVT or thrombotic events
  13. No history of prior organ transplant
  14. Female subjects of childbearing potential will need to have a negative pregnancy test performed within 14 days prior to study procedure (if applicable) and be adherent to an accepted method of contraception.
  15. Male subject will need to adhere to barrier contraception during the course of the trial and for 1 month after completion of the final injection of Cuvitru.
  16. Ability to sign informed consent

Exclusion criteria:

  1. Known history of humoral dysfunction/immunodeficiency
  2. Known hereditary/genetic/congenital defects, and autoimmune disease including hereditary spherocytosis, hereditary elliptocytosis, paroxysmal nocturnal hemoglobinuria, and sickle cell disease
  3. Ongoing or recent therapy with immunoglobulin replacement therapy within the past 6 months
  4. Chronic oral steroid use of prednisone treatment of ≥20 mg daily (or equivalent) will be excluded to ensure subject is medically stable.
  5. Alpha-1 antitrypsin deficiency
  6. Obesity with a BMI > 40
  7. Unstable hypertension systolic blood pressure (SBP) >160 mmHg upon repeated measure
  8. Diabetes mellitus Type I
  9. Known history of acquired or inherited thrombophilia disorders
  10. Known risk factors of hemolysis, including G6PD deficiency, mitral valve replacement, aortic valve replacement.
  11. Known prolonged periods of immobilization
  12. Known severe hypovolemia noted by SBP ≤ 85 and/or heart rate (HR) >130
  13. Known hypercoagulable conditions
  14. Use of estrogens
  15. Indwelling central vascular catheters
  16. Currently actively smoking

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 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.
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rochester General Hospital

Collaborators

Takeda

Investigators

  • Principal Investigator: Syed S Mustafa, MD, Rochester General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2023

Primary Completion (Estimated)

February 28, 2025

Study Completion (Estimated)

December 30, 2025

Study Registration Dates

First Submitted

November 29, 2022

First Submitted That Met QC Criteria

February 28, 2023

First Posted (Actual)

March 13, 2023

Study Record Updates

Last Update Posted (Actual)

June 15, 2023

Last Update Submitted That Met QC Criteria

June 13, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IISR Protocol

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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