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

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ClinicalTrials.gov Identifier: NCT02067377
Recruitment Status : Completed
First Posted : February 20, 2014
Last Update Posted : September 2, 2016
Sponsor:
Collaborator:
Entera Health, Inc
Information provided by (Responsible Party):
Medical University of South Carolina

Tracking Information
First Submitted Date  ICMJE February 6, 2014
First Posted Date  ICMJE February 20, 2014
Last Update Posted Date September 2, 2016
Study Start Date  ICMJE December 2013
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 18, 2014)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 18, 2014)
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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: February 18, 2014)
  • 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 ]
  • 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 ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Efficacy of Serum Bovine Immunoglobulin in Improving Nutritional Status in Advanced COPD
Official Title  ICMJE A Randomized, Double Blinded, Placebo-controlled Pilot Study of Serum Bovine Immunoglobulin (SBI) for Cachexia in Patients With Advanced COPD
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Advanced COPD (GOLD Stage 3 or 4) With Cachexia
Intervention  ICMJE
  • 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.
  • Dietary Supplement: Placebo (for serum bovine immunoglobulin)
Study Arms  ICMJE
  • Placebo Comparator: inactive powder substance
    inactive powder substance by mouth twice a day for 6 months
    Intervention: 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
    Intervention: Dietary Supplement: Serum bovine immunoglobulin (SBI) medical food
  • Experimental: serum bovine immunoglobulin (SBI) medicalfood
    SBI medical food 10 gr powder substance by mouth twice a day for 6 months
    Intervention: Dietary Supplement: Serum bovine immunoglobulin (SBI) medical food
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 1, 2016)
12
Original Estimated Enrollment  ICMJE
 (submitted: February 18, 2014)
24
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02067377
Other Study ID Numbers  ICMJE 000027289
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Medical University of South Carolina
Study Sponsor  ICMJE Medical University of South Carolina
Collaborators  ICMJE Entera Health, Inc
Investigators  ICMJE
Principal Investigator: Luca Paoletti, MD Medical University of South Carolina
PRS Account Medical University of South Carolina
Verification Date August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP