Advanced COPD (GOLD Stage 3 or 4) With CachexiaSBI for COPDNCT02067377
Efficacy of Serum Bovine Immunoglobulin in Improving Nutritional Status in Advanced COPD
A study testing Serum bovine immunoglobulin (SBI) medical food in people with Advanced COPD (GOLD Stage 3 or 4) With Cachexia, run by Medical University of South Carolina at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Advanced COPD (GOLD Stage 3 or 4) With Cachexia
- What is being tested?
- Serum bovine immunoglobulin (SBI) medical food
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2013to Apr 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: A Randomized, Double Blinded, Placebo-controlled Pilot Study of Serum Bovine Immunoglobulin (SBI) for Cachexia in Patients With Advanced COPD
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.
- Being tested
- Serum bovine immunoglobulin (SBI) medical food, Placebo (for serum bovine immunoglobulin)
- Keywords
- GOLD, COPD, cachexia, BMI
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Cachexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serum bovine immunoglobulin (SBI) medical foodDietary supplement
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.
Placebo (for serum bovine immunoglobulin)Dietary supplement
| Study group | Role | What they receive |
|---|---|---|
| inactive powder substance | Placebo comparator | inactive powder substance by mouth twice a day for 6 months Receives: Dietary Supplement: Placebo (for serum bovine immunoglobulin) |
| serum bovine immunoglobulin (SBI) medical food | Experimental | SBI medical food 5 gr powder substance by mouth twice a day for 6 months Receives: Dietary Supplement: Serum bovine immunoglobulin (SBI) medical food |
| serum bovine immunoglobulin (SBI) medicalfood | Experimental | SBI medical food 10 gr powder substance by mouth twice a day for 6 months Receives: Dietary Supplement: Serum bovine immunoglobulin (SBI) medical food |
What is being measured
The primary outcome is the main question the study is designed to answer.
The subtracted differences in BMI, body fat measurement, and grip strength between participants receiving SBI or placebo at baseline and 6 months.
Measured: 6 months
Secondary outcomes (1)
The subtracted differences between FEV1 and COPD Assessment Test scores in patients receiving SBI or placebo at baseline and 6 months.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2014 (estimated)
- Study startDec 2013
- Primary completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced COPD (GOLD Stage 3 or 4) With CachexiaStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- Entera Health, Inc
- Responsible party
- Sponsor
- Investigators
- Luca Paoletti, MD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02067377
- Sponsor's protocol ID
- 000027289
- Acronym
- SBI for COPD
- Status last verified
- Aug 2013
- First submitted
- 6 Feb 2014
- Last updated
- 2 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blinded, Placebo-controlled Pilot Study of Serum Bovine Immunoglobulin (SBI) for Cachexia in Patients With Advanced COPD
- ClinicalTrials.gov ID
- NCT02067377
- Acronym / sponsor ID
- SBI for COPD / 000027289
- Keywords
- GOLD, COPD, cachexia, BMI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- Entera Health, Inc
- Study start
- Dec 2013
- Primary completion
- Apr 2016 (actual)
- First posted
- 20 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| inactive powder substance | Placebo comparator | Dietary Supplement: Placebo (for serum bovine immunoglobulin)inactive powder substance by mouth twice a day for 6 months |
| serum bovine immunoglobulin (SBI) medical food | Experimental | Dietary Supplement: Serum bovine immunoglobulin (SBI) medical foodSBI medical food 5 gr powder substance by mouth twice a day for 6 months |
| serum bovine immunoglobulin (SBI) medicalfood | Experimental | Dietary Supplement: Serum bovine immunoglobulin (SBI) medical foodSBI medical food 10 gr powder substance by mouth twice a day for 6 months |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Serum bovine immunoglobulin (SBI) medical foodSerum 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 | serum bovine immunoglobulin (SBI) medical food, serum bovine immunoglobulin (SBI) medicalfood |
| Placebo (for serum bovine immunoglobulin) | Dietary supplement | inactive powder substance |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2016.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luca Paoletti, MD principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Serum bovine immunoglobulin (SBI) medical food in people with Advanced COPD (GOLD Stage 3 or 4) With Cachexia, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2016.