Clinical trial NCT02067377: Efficacy of Serum Bovine Immunoglobulin in Improving Nutritional Status in Advanced 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
Overall status: COMPLETED
Phase: NA
Conditions: Advanced COPD (GOLD Stage 3 or 4) With Cachexia
Keywords: GOLD, COPD, cachexia, BMI
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: Entera Health, Inc
First posted: 2014-02-20
Enrollment: 12
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: The subtracted differences in BMI, body fat measurement, and grip strength between participants receiving SBI or placebo at baseline and 6 months.
timeFrame: 6 months
Secondary outcomes:
measure: The subtracted differences between FEV1 and COPD Assessment Test scores in patients receiving SBI or placebo at baseline and 6 months.
timeFrame: 6 months
Other outcomes:
measure: The subtracted differences in swallowing-associated laryngeal Penetration Aspiration Scale (PAS) in patients receiving SBI or placebo at baseline and 6 months.
timeFrame: 6 months
measure: The subtracted differences in mean serum TNF-alpha and IL-6 concentrations between participants receiving SBI or placebo at baseline and 6 months.
timeFrame: 6 months
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Luca Paoletti, MD
role: PRINCIPAL_INVESTIGATOR
References: