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

September 1, 2016 updated by: Medical University of South Carolina

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: inactive powder substance
inactive powder substance by mouth twice a day for 6 months
Dietary supplement: Placebo (for serum bovine immunoglobulin)
Experimental: serum bovine immunoglobulin (SBI) medical food
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) 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.
Experimental: serum bovine immunoglobulin (SBI) medicalfood
SBI medical food 10 gr powder substance by mouth twice a day for 6 months
Dietary supplement: Serum bovine immunoglobulin (SBI) medical food
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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
6 months

Other Outcome Measures

Outcome Measure
Time Frame
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
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.
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of South Carolina

Collaborators

Entera Health, Inc

Investigators

  • Principal Investigator: Luca Paoletti, MD, Medical University of South Carolina

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

February 6, 2014

First Submitted That Met QC Criteria

February 18, 2014

First Posted (Estimate)

February 20, 2014

Study Record Updates

Last Update Posted (Estimate)

September 2, 2016

Last Update Submitted That Met QC Criteria

September 1, 2016

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 000027289

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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