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

Completed · Not applicable · Has a placebo group

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

In brief

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.

Key facts

Study ID

NCT02067377

Run by

Medical University of South Carolina

People needed

12

Starts

2013-12-01

Last updated by the study team

2016-09-02

Who can join

Age: 30 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Medical University of South Carolina — Charleston, South Carolina, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.