Clinical Trials Logo
  1. Home
  2. Copd Exacerbation Acute
  3. NCT05764993

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

COPD Exacerbation Acute Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05764993
Study type Interventional
Source Rochester General Hospital
Contact Dawn Sheflin, RN
Phone 585-922-8314
Email Dawn.Sheflin@RochesterRegional.org
Status Recruiting
Phase Phase 2
Start date June 1, 2023
Completion date December 30, 2025
View Details
See also
  Status Clinical Trial Phase
Terminated NCT05418777 - Treatment of Pneumocystis in COPD (the TOPIC Study) Phase 1/Phase 2
Not yet recruiting NCT05649891 - Checklists Resuscitation Emergency Department N/A
Completed NCT03286855 - Effectiveness of Vibrating Mesh Versus Small Volume Nebuliser in Chronic Obstructive Pulmonary Disease (COPD) N/A
Recruiting NCT06021990 - Clopidogrel for the Prevention of Exacerbations in Severe COPD Phase 3
Completed NCT05218525 - Testing a Prediction Algorithm Into a Running Telehealth System for Patients With COPD N/A
Recruiting NCT06149494 - RCT of Vapendavir in Patients With COPD and Human Rhinovirus/Enterovirus Upper Respiratory Infection Phase 2
Recruiting NCT05734365 - COPD-ICU Multicentre Prospective Observational Register
Completed NCT03464695 - Automated Oxygen Delivery by O2matic to Patients Admitted With an Exacerbation in COPD N/A
Recruiting NCT04881409 - Nasal High-flow Compared to Non-invasive Ventilation in Treatment of Acute Acidotic Hypercapnic Exacerbation of Chronic Obstructive Pulmonary Disease N/A
Completed NCT05182294 - Tolerance and Acute Effects of a New HFNT Nasal Cannula N/A
Completed NCT04821869 - ProAir Digihaler in COPD Disease Management: A Real World Study
Recruiting NCT06274957 - The Effect of Airway and Chest Wall Oscillation on Respiratory Functions in COPD Patients in Acute Exacerbation N/A
Recruiting NCT05783544 - Impact of A. Lumbricoides on Pulmonary Aspergillosis Development N/A
Recruiting NCT06331416 - Multiparametric Home Telemonitoring of Patients With Chronic Obstructive Pulmonary Disease Exacerbation N/A
Not yet recruiting NCT05703919 - Standard vs Targeted Oxygen Therapy Prehospital for Chronic Obstructive Pulmonary Disease Phase 4
Not yet recruiting NCT06419036 - The Use of Medical Devices to Monitor Chronic Obstructive Pulmonary Disease Patients Study BREATH-TRACHER 1
Not yet recruiting NCT06419062 - The Use of Medical Devices to Monitor Chronic Obstructive Pulmonary Disease Patients Study BREATH-TRACHER 2
Completed NCT06040931 - Airway Inflammation, Small Airways Dysfunction, and Frequency of Exacerbations in COPD N/A
Active, not recruiting NCT04192175 - Identification of Patients Admitted With COPD Exacerbations and Predicting Readmission Risk Using Machine Learning
Recruiting NCT03680495 - Steroid Resistance During COPD Exacerbations With Respiratory Failure