Examining immune dysfunction in COPD patients and its treatment
Official title: Prevalence of Humoral Immune Deficiency in Patients With Frequent Exacerbations of COPD, and the Effect of Immunoglobulin Replacement on Future Exacerbations
Run by Rochester General Hospital · NCT05764993 · Data updated 2026-05-14
This study is no longer in our active list. It may have stopped recruiting or finished. The details below are as of 2026-05-14 and are kept for reference. Check ClinicalTrials.gov for its current status, or see similar studies below.
This study is testing if a new immune therapy can help people with COPD who have low antibody levels experience fewer flare-ups of their condition.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 82 Years |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | Rochester General Hospital Academic / other |
| Drugs / interventions | prednisone |
| Locations | 3 sites (Rochester, New York and 2 other locations) |
| Trial ID | NCT05764993 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 to 82 with a diagnosis of COPD and a history of frequent exacerbations despite standard therapy.
✕Probably not a fit
Patients without humoral dysfunction or those not meeting the inclusion criteria may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the prevalence of humoral immunodeficiency in patients with Chronic Obstructive Pulmonary Disease (COPD) by assessing immunoglobulin levels and vaccine responses. Patients identified with humoral dysfunction will be randomized to receive either Subcutaneous Immune Globulin Replacement Therapy (SCIgR) or standard care management. The aim is to determine if SCIgR can reduce the frequency of acute exacerbations of COPD. The study will involve evaluations at outpatient pulmonary clinics and will include a total of 40 patients.
Why it matters
Potential benefit: If successful, this study could lead to improved management and reduced exacerbations for COPD patients with humoral dysfunction.
How similar studies have gone: Other studies have shown promise in treating humoral dysfunction in similar patient populations, suggesting potential for success in this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Rochester Regional Health Ctr for Clinical Research - Alexander Park
Rochester, New York, United States Recruiting -
Rochester Regional Health - Ctr for Clinical Research - Linden Oaks
Rochester, New York, United States Recruiting -
Rochester Regional Health - Ctr for Clinical Research - Greece
Rochester, New York, United States Recruiting
Study contacts
- Principal investigator: Syed S Mustafa, MD — Rochester General Hospital
- Study coordinator: Dawn Sheflin, RN
- Email: Dawn.Sheflin@RochesterRegional.org
- Phone: 585-922-8314
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Rademikibart IV for Acute Asthma and COPD Exacerbation
This study tests a one-time IV dose of rademikibart to help people with acute asthma or COPD flare-ups who need urgent care.
-
Observational registry for COPD patients in ICU
This study is looking at patients with severe COPD who are in the ICU to see how they are treated and what happens to them, in hopes of improving care for future patients.
-
Titrated versus standard oxygen for prehospital treatment of COPD exacerbations
This trial tests whether giving oxygen adjusted to keep blood oxygen (SpO₂) at 88–92% instead of using 100% oxygen during prehospital treatment of adults 40 and older with suspected COPD exacerbations lowers 30-day death.
-
Hospitalized adults with acute or chronic respiratory conditions: outcomes and recovery
This study tests how adults hospitalized with acute respiratory problems or chronic lung disease recover after discharge, and what factors predict readmission, stay length, and mortality.
-
Evaluating how high doses of prednisolone affect patients with inflammatory conditions
This study is trying to see how different doses of prednisolone affect patients with inflammatory conditions by looking at their blood levels and how their bodies process the medication.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.