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

NCT02067377 | Completed

• 1 other identifier: 000027289
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Advanced COPD (GOLD Stage 3 or 4) With Cachexia

Keywords

GOLD, COPD, cachexia, BMI

Outcome Measures

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.

  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.

  6 months

Other Outcomes (2)

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

  6 months

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

  6 months

Study Arms (3)

inactive powder substance

PLACEBO COMPARATOR

inactive powder substance by mouth twice a day for 6 months

Dietary Supplement: Placebo (for serum bovine immunoglobulin)

serum bovine immunoglobulin (SBI) medical food

EXPERIMENTAL

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

Dietary Supplement: Serum bovine immunoglobulin (SBI) medical food

serum bovine immunoglobulin (SBI) medicalfood

EXPERIMENTAL

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

Dietary Supplement: Serum bovine immunoglobulin (SBI) medical food

Interventions

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.

serum bovine immunoglobulin (SBI) medical food; serum bovine immunoglobulin (SBI) medicalfood

Placebo (for serum bovine immunoglobulin) DIETARY_SUPPLEMENT

inactive powder substance

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Medical University of South Carolina: lead
• Entera Health, Inc: collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Cachexia

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Weight Loss; Body Weight Changes; Body Weight; Signs and Symptoms; Thinness

Study Officials

• Luca Paoletti, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2014
• First Posted: February 20, 2014
• Study Start: December 1, 2013
• Primary Completion: April 1, 2016
• Last Updated: September 2, 2016

Record last verified: 2013-08

Locations

US (1)