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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02067377
Recruitment Status : Completed
First Posted : February 20, 2014
Last Update Posted : September 2, 2016
Sponsor:
Collaborator:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Advanced COPD (GOLD Stage 3 or 4) With Cachexia Dietary Supplement: Serum bovine immunoglobulin (SBI) medical food Dietary Supplement: Placebo (for serum bovine immunoglobulin)

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double Blinded, Placebo-controlled Pilot Study of Serum Bovine Immunoglobulin (SBI) for Cachexia in Patients With Advanced COPD
Study Start Date : December 2013
Primary Completion Date : April 2016
Arms and Interventions

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.


Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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 ]

Eligibility Criteria

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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02067377


Locations
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medical University of South Carolina
Entera Health, Inc
Investigators
Principal Investigator: Luca Paoletti, MD Medical University of South Carolina
More Information

Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT02067377     History of Changes
Other Study ID Numbers: 000027289
First Posted: February 20, 2014    Key Record Dates
Last Update Posted: September 2, 2016
Last Verified: August 2013

Keywords provided by Medical University of South Carolina:
GOLD, COPD, cachexia, BMI

Additional relevant MeSH terms:
Cachexia
Wasting Syndrome
Emaciation
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms
Metabolic Diseases
Nutrition Disorders
Immunoglobulins
Antibodies
Immunologic Factors
Physiological Effects of Drugs