Back to resultsEfficacy of Serum Bovine Immunoglobulin in Improving Nutritional Status in Advanced COPD (SBI for COPD)
Primary Purpose
Advanced COPD (GOLD Stage 3 or 4) With Cachexia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Serum bovine immunoglobulin (SBI) medical food
Placebo (for serum bovine immunoglobulin)
Sponsored by
About this trial
This is an interventional treatment trial for Advanced COPD (GOLD Stage 3 or 4) With Cachexia focused on measuring GOLD, COPD, cachexia, BMI
Eligibility Criteria
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)
Sites / Locations
- Medical University of South Carolina
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Experimental
Arm Label
inactive powder substance
serum bovine immunoglobulin (SBI) medical food
serum bovine immunoglobulin (SBI) medicalfood
Arm Description
inactive powder substance by mouth twice a day for 6 months
SBI medical food 5 gr powder substance by mouth twice a day for 6 months
SBI medical food 10 gr powder substance by mouth twice a day for 6 months
Outcomes
Primary Outcome Measures
The subtracted differences in BMI, body fat measurement, and grip strength between participants receiving SBI or placebo at baseline and 6 months.
Secondary Outcome Measures
The subtracted differences between FEV1 and COPD Assessment Test scores in patients receiving SBI or placebo at baseline and 6 months.
Full Information
NCT ID
NCT02067377
First Posted
February 6, 2014
Last Updated
September 1, 2016
Sponsor
Medical University of South Carolina
Collaborators
Entera Health, Inc
1. Study Identification
Unique Protocol Identification Number
NCT02067377
Brief Title
Efficacy of Serum Bovine Immunoglobulin in Improving Nutritional Status in Advanced COPD
Acronym
SBI for COPD
Official Title
A Randomized, Double Blinded, Placebo-controlled Pilot Study of Serum Bovine Immunoglobulin (SBI) for Cachexia in Patients With Advanced COPD
Study Type
Interventional
2. Study Status
Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of South Carolina
Collaborators
Entera Health, Inc
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced COPD (GOLD Stage 3 or 4) With Cachexia
Keywords
GOLD, COPD, cachexia, BMI
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
inactive powder substance
Arm Type
Placebo Comparator
Arm Description
inactive powder substance by mouth twice a day for 6 months
Arm Title
serum bovine immunoglobulin (SBI) medical food
Arm Type
Experimental
Arm Description
SBI medical food 5 gr powder substance by mouth twice a day for 6 months
Arm Title
serum bovine immunoglobulin (SBI) medicalfood
Arm Type
Experimental
Arm Description
SBI medical food 10 gr powder substance by mouth twice a day for 6 months
Intervention Type
Dietary Supplement
Intervention Name(s)
Serum bovine immunoglobulin (SBI) medical food
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo (for serum bovine immunoglobulin)
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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 Pre-specified Outcome Measures:
Title
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
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luca Paoletti, MD
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Serum Bovine Immunoglobulin in Improving Nutritional Status in Advanced COPD
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