Efficacy of Serum Bovine Immunoglobulin in Improving Nutritional Status in Advanced COPD (SBI for COPD)

Medical University of South Carolina (MUSC)

Status: Completed

Conditions: Advanced COPD (GOLD Stage 3 or 4) With Cachexia

Treatments: Dietary Supplement: Serum bovine immunoglobulin (SBI) medical food; Dietary Supplement: Placebo (for serum bovine immunoglobulin)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02067377

000027289

Details and patient eligibility

About

This study will evaluate the use of a medical food, oral serum-derived bovine immunoglobulin/protein isolate (SBI), in helping patients with advanced COPD with cachexia (a wasting syndrome) improve their nutritional status and gain weight. The medical food is in powder form and is mixed with a liquid such as water or orange juice and consumed by swallowing. The primary hypothesis is that SBI protein isolate (SBI) will improve the nutritional status of cachexic patients with advanced stages of COPD.

Enrollment: 12 patients

Sex: All

Ages: 30 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age between age 30 and 80 at Baseline Visit
• Diagnosed with 2012 spirometric COPD GOLD Stage 3 (FEV1/FVC ratio <0.70, FEV1 30-49% of normal) or GOLD Stage 4 (FEV1/FVC <0.70, FEV1 <30% of normal or FEV1<50% of normal with chronic respiratory failure present)
• Able to tolerate and willing to undergo study procedures
• Body Mass Index below 21
• Signed Informed Consent

Exclusion criteria

• History of comorbid condition severe enough to significantly impact 6 months outcomes
• Current substance abuse, including tobacco, alcohol and illicit drugs
• Diagnosis of unstable cardiovascular disease including myocardial infarction in the past 6 weeks, uncontrolled congestive heart failure, or uncontrolled arrhythmia
• Dementia or other cognitive dysfunction which in the opinion of the investigator would prevent the participant from consenting to the study or completing study procedures
• Active pulmonary infection with tuberculosis
• Non-COPD obstructive lung disease (various bronchiolitides, sarcoidosis, LAM, histiocytosis X) or parenchymal lung disease, pulmonary vascular disease, pleural disease, severe kyphoscoliosis, neuromuscular weakness, or other cardiovascular and pulmonary disease, that limit the interpretability of the pulmonary function measures
• Prior significant difficulties with pulmonary function testing
• Hypersensitivity to or intolerance of albuterol sulfate or ipratropium bromide or propellants or excipients of the inhalers, or to beef
• History of lung or other organ transplant
• Currently taking >20mg of prednisone or equivalent systemic corticosteroid
• Currently taking any immunosuppressive agent
• History of lung cancer or any cancer that spread to multiple locations in the body
• Known HIV/AIDS infection
• History of or current exposure to chemotherapy or radiation treatments that, in the opinion of the investigator, limits the interpretability of the pulmonary function measures.
• Current or planned pregnancy within the study course.
• Currently institutionalized (e.g., prisons, long-term care facilities)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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12 participants in 3 patient groups, including a placebo group

inactive powder substance

Placebo Comparator group

Description:

inactive powder substance by mouth twice a day for 6 months

Treatment:

Dietary Supplement: Placebo (for serum bovine immunoglobulin)

serum bovine immunoglobulin (SBI) medical food

Experimental group

Description:

SBI medical food 5 gr powder substance by mouth twice a day for 6 months

Treatment:

Dietary Supplement: Serum bovine immunoglobulin (SBI) medical food

serum bovine immunoglobulin (SBI) medicalfood

Experimental group

Description:

SBI medical food 10 gr powder substance by mouth twice a day for 6 months

Treatment:

Dietary Supplement: Serum bovine immunoglobulin (SBI) medical food