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

NCT05764993 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2023-06-15

No results posted yet for this study

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.

Conditions

  • COPD Exacerbation Acute

Interventions

BIOLOGICAL

CUVITRU - Ig subcutaneous human 20%

Subcutaneous Immunoglobin Replacement Therapy, SCigR

OTHER

Standard Medical Therapy

Standard Medical Therapy

Sponsors & Collaborators

  • Takeda

    collaborator INDUSTRY

  • Rochester General Hospital

    lead OTHER

Principal Investigators

  • Syed S Mustafa, MD · Rochester General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
82 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-01
Primary Completion
2025-02-28
Completion
2025-12-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05764993 on ClinicalTrials.gov