RECRUITING

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

Conditions

COPD Exacerbation Acute humoral dysfunction humoral immune function

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-06-01

Study Completion:2025-12-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05764993

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.

Ages Eligible for Study:18 Years to 82 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	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

Inclusion Criteria

Exclusion 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

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

Contacts and Locations

Study Contact

Dawn Sheflin, RN

CONTACT

585-922-8314

Dawn.Sheflin@RochesterRegional.org

Holly Blue, LPN

CONTACT

585-922-8314

Holly.Blue@RochesterRegional.org

Principal Investigator

Syed S Mustafa, MD

PRINCIPAL_INVESTIGATOR

Rochester General Hospital

Study Locations (Sites)

Rochester Regional Health Ctr for Clinical Research - Alexander Park

Rochester, New York, 14607

United States

Rochester Regional Health - Ctr for Clinical Research - Linden Oaks

Rochester, New York, 14625

United States

Rochester Regional Health - Ctr for Clinical Research - Greece

Rochester, New York, 14626

United States

Collaborators and Investigators

Sponsor: Rochester General Hospital

Syed S Mustafa, MD, PRINCIPAL_INVESTIGATOR, Rochester General Hospital

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 Registration Dates

Study Start Date2023-06-01

Study Completion Date2025-12-30

Study Record Updates

Study Start Date2023-06-01

Study Completion Date2025-12-30

Terms related to this study

Keywords Provided by Researchers

humoral dysfunction
humoral immune function

Additional Relevant MeSH Terms

COPD Exacerbation Acute