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Immunoglobulin Replacement Therapy
SCIg Therapy for COPD
Phase 2
Recruiting
Led By Syed S Mustafa, MD
Research Sponsored by Rochester General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one year
Summary
This trial uses a treatment to help COPD patients with immune system problems by boosting the body's antibodies to fight infections. The therapy has been shown to be effective and safe, with benefits such as improved efficacy, tolerability, and patient satisfaction.
Who is the study for?
Adults aged 18-82 with COPD who've had at least two severe flare-ups in the past year or one requiring hospitalization, despite being on triple therapy for over 90 days. They must be medically stable, not currently smoking, and without certain other health issues like severe liver or kidney disease, blood clotting disorders, or a history of organ transplant.
What is being tested?
The trial is testing if Subcutaneous Immune Globulin Replacement Therapy (SCIgR) can reduce exacerbations in COPD patients with humoral immunodeficiency. It involves comparing SCIgR plus standard medical therapy against standard treatment alone to see which is more effective.
What are the potential side effects?
Possible side effects of SCIgR include injection site reactions such as redness and swelling, headache, fatigue, nausea, fever and chills. Rarely it may cause systemic allergic reactions or worsen pre-existing heart conditions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ one year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
AECOPD requiring treatment with systemic steroids over one year
Secondary study objectives
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.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Group #1Experimental Treatment2 Interventions
SCIgR with Cuvitru 125 mg/kg/week + standard of care management
Group II: Group #2Placebo Group1 Intervention
Standard of care management = 20 patients
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Chronic Obstructive Pulmonary Disease (COPD) include bronchodilators, corticosteroids, phosphodiesterase inhibitors, and immune-based therapies. Bronchodilators, such as long-acting beta agonists (LABAs) and long-acting muscarinic antagonists (LAMAs), work by relaxing the muscles around the airways, improving airflow and reducing symptoms like shortness of breath.
Corticosteroids reduce inflammation in the airways, decreasing the frequency and severity of exacerbations. Phosphodiesterase inhibitors, like roflumilast, help reduce inflammation and mucus production, particularly in patients with chronic bronchitis.
Immune-based therapies, such as Subcutaneous Immune Globulin Replacement Therapy (SCIgR), provide exogenous immunoglobulins to enhance the immune response and reduce infections, which is crucial for preventing exacerbations in patients with humoral immunodeficiency. These treatments are essential for managing COPD as they target different aspects of the disease, improving lung function, reducing symptoms, and preventing exacerbations, thereby enhancing the quality of life for patients.
Relationships between Airway Remodeling and Clinical Characteristics in COPD Patients.Comprehensive analysis of allergen-specific IgE in COPD: mite-specific IgE specifically related to the diagnosis of asthma-COPD overlap.Identification of proteomic signatures associated with COPD frequent exacerbators.
Relationships between Airway Remodeling and Clinical Characteristics in COPD Patients.Comprehensive analysis of allergen-specific IgE in COPD: mite-specific IgE specifically related to the diagnosis of asthma-COPD overlap.Identification of proteomic signatures associated with COPD frequent exacerbators.
Find a Location
Who is running the clinical trial?
Rochester General HospitalLead Sponsor
13 Previous Clinical Trials
2,238 Total Patients Enrolled
TakedaIndustry Sponsor
1,240 Previous Clinical Trials
4,149,431 Total Patients Enrolled
Syed S Mustafa, MDPrincipal InvestigatorRochester General Hospital
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have never had a pulmonary embolism or similar blood clot event.I have never had a blood clot.I am between 19 and 82 years old.Your heart is beating faster than 95 beats per minute.Your breathing rate is faster than 24 breaths per minute.I have smoked the equivalent of 10 or more pack years.Your health is stable according to medical standards.
Research Study Groups:
This trial has the following groups:- Group 1: Group #1
- Group 2: Group #2
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
COPD exacerbation Patient Testimony for trial: Trial Name: NCT05764993 — Phase 2