Advanced COPD (GOLD Stage 3 or 4) With Cachexia Clinical Trial
— SBI for COPDOfficial title:
A Randomized, Double Blinded, Placebo-controlled Pilot Study of Serum Bovine Immunoglobulin (SBI) for Cachexia in Patients With Advanced COPD
| NCT number | NCT02067377 |
| Other study ID # | 000027289 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | February 6, 2014 |
| Last updated | September 1, 2016 |
| Start date | December 2013 |
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.
| Status | Completed |
| Enrollment | 12 |
| Est. completion date | |
| Est. primary completion date | April 2016 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 30 Years to 80 Years |
| Eligibility |
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) |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Medical University of South Carolina | Charleston | South Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Medical University of South Carolina | Entera Health, Inc |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | The subtracted differences in swallowing-associated laryngeal Penetration Aspiration Scale (PAS) in patients receiving SBI or placebo at baseline and 6 months. | 6 months | No | |
| Other | The subtracted differences in mean serum TNF-alpha and IL-6 concentrations between participants receiving SBI or placebo at baseline and 6 months. | 6 months | No | |
| Primary | The subtracted differences in BMI, body fat measurement, and grip strength between participants receiving SBI or placebo at baseline and 6 months. | 6 months | No | |
| Secondary | The subtracted differences between FEV1 and COPD Assessment Test scores in patients receiving SBI or placebo at baseline and 6 months. | 6 months | No |