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Completed

NCT Number: NCT02067377

Efficacy of Serum Bovine Immunoglobulin in Improving Nutritional Status in 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.

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Key information

Conditions

Advanced COPD (GOLD Stage 3 or 4) With Cachexia Body Weight Body Weight Changes Cachexia Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases Signs and Symptoms Thinness Weight Loss

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Serum bovine immunoglobulin (SBI) medical food

Dietary Supplement

Serum bovine immunoglobulin (SBI) is an FDA regulated, orally administered prescription medical food intended for the nutritional management of patients who are unable to absorb necessary nutrients as a result of therapeutic or chronic medical problems.

Placebo (for serum bovine immunoglobulin)

Dietary Supplement

Primary outcomes

  1. The subtracted differences in BMI, body fat measurement, and grip strength between participants receiving SBI or placebo at baseline and 6 months.

    Time frame: 6 months

Secondary outcomes

  1. The subtracted differences between FEV1 and COPD Assessment Test scores in patients receiving SBI or placebo at baseline and 6 months.

    Time frame: 6 months

Other outcomes

  1. The subtracted differences in swallowing-associated laryngeal Penetration Aspiration Scale (PAS) in patients receiving SBI or placebo at baseline and 6 months.

    Time frame: 6 months

  2. The subtracted differences in mean serum TNF-alpha and IL-6 concentrations between participants receiving SBI or placebo at baseline and 6 months.

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Collaborators

  • Entera Health, Inc

Registry information

Official study title

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

Acronym: SBI for COPD

Important dates

Study start
2013
Primary completion
2016
First posted
Feb 20, 2014
Registry last updated
Sep 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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