Efficacy of Serum Bovine Immunoglobulin in Improving Nutritional Status in Advanced COPD



Status:Recruiting
Conditions:Chronic Obstructive Pulmonary Disease
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:30 - 80
Updated:4/2/2016
Start Date:December 2013
Contact:Kalon Eways, BS
Email:eways@musc.edu
Phone:843-792-6696

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A Randomized, Double Blinded, Placebo-controlled Pilot Study of Serum Bovine Immunoglobulin (SBI) for Cachexia in Patients With Advanced COPD

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.


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)
We found this trial at
1
site
171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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Charleston, SC
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