What side effects are associated with this type of intervention?

Common treatments for COPD include bronchodilators, inhaled corticosteroids, phosphodiesterase inhibitors, and immunoglobulin replacement therapies. Bronchodilators like theophylline can cause side effects such as nausea, headache, and insomnia. Inhaled corticosteroids may lead to oral thrush, hoarseness, and an increased risk of pneumonia. Phosphodiesterase inhibitors like roflumilast can cause weight loss, diarrhea, and psychiatric symptoms. Subcutaneous Immune Globulin Replacement Therapy (SCIgR), which provides exogenous immunoglobulins, can cause local reactions at the injection site, headaches, and fatigue. These treatments aim to improve lung function, reduce exacerbations, and enhance the immune response.

What prior FDA approvals exist?

The FDA has approved various treatments for Chronic Obstructive Pulmonary Disease (COPD), primarily focusing on bronchodilators, inhaled corticosteroids, and combination therapies to manage symptoms and reduce exacerbations. While Subcutaneous Immune Globulin Replacement Therapy (SCIgR) is being studied for its potential to enhance the immune response and reduce infections in COPD patients, there are no specific FDA-approved immunoglobulin therapies for COPD as of now. Current treatments include long-acting muscarinic antagonists (LAMAs), long-acting beta-agonists (LABAs), and inhaled corticosteroids (ICS), often used in combination to improve lung function and quality of life.

What other types of research exist?

Promising novel alternatives to SCIgR for COPD patients include biologic therapies such as monoclonal antibodies targeting specific inflammatory pathways. For example, tezepelumab, an anti-TSLP antibody, has shown efficacy in reducing exacerbations in severe asthma and may have potential applications in COPD. Additionally, other biologics like dupilumab, which targets IL-4 and IL-13 pathways, could also be considered for their anti-inflammatory effects. These therapies are still under investigation for COPD but represent a promising direction for enhancing immune response and reducing infections.

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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

Awards & highlights

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and one year for reporting.

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

Do I qualify?Apply below to find out

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.

Find a Location

Who is running the clinical trial?

Rochester General HospitalLead Sponsor

13 Previous Clinical Trials

2,238 Total Patients Enrolled

TakedaIndustry Sponsor

1,227 Previous Clinical Trials

4,222,465 Total Patients Enrolled

Syed S Mustafa, MDPrincipal InvestigatorRochester General Hospital

Media Library

CUVITRU - Ig subcutaneous human 20% (Immunoglobulin Replacement Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05764993 — Phase 2

Chronic Obstructive Pulmonary Disease Research Study Groups: Group #1, Group #2

Chronic Obstructive Pulmonary Disease Clinical Trial 2023: CUVITRU - Ig subcutaneous human 20% Highlights & Side Effects. Trial Name: NCT05764993 — Phase 2

CUVITRU - Ig subcutaneous human 20% (Immunoglobulin Replacement Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05764993 — Phase 2

Chronic Obstructive Pulmonary Disease Patient Testimony for trial: Trial Name: NCT05764993 — Phase 2

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