Chronic Obstructive Pulmonary DiseaseCOD-FishNCT00835289
The Chronic Obstructive Pulmonary Disease Fish Oil Pilot Trial
A study testing n-3 polyunsaturated fatty acids in people with Chronic Obstructive Pulmonary Disease, run by Columbia University at 1 site in United States.
Trial summary
Chronic obstructive pulmonary disease (COPD) is currently the fourth leading cause of death in the United States. Unlike the other leading causes of death, no medical therapies currently available improve the course of disease or affect survival in COPD. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- n-3 polyunsaturated fatty acids
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to Aug 2013
- 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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Post-bronchodilator FEV1/FVC ratio <70%
- Post-bronchodilator FEV1 <65% predicted.
- Clinical diagnosis of COPD
- Stable medical regimen for 30 days prior to enrollment
- Age > 40 years old
- History of former cigarette smoking, > or = 10 pack years
Who cannot join
- COPD exacerbation or hospitalization for COPD in the past 30 days
- Confirmed history of physician-diagnosed asthma
- History of unrelated pulmonary disease (e.g. interstitial lung disease, thromboembolic disease)
- Status-post lung transplantation or Lung volume reduction surgery (LVRS)
- Systolic blood pressure >170mmHg or<100mmHg at rest, diastolic blood pressure >100 at rest, or resting HR >120.
- Active cigarette smoking
Show all 27Show fewer
- Clinical diagnosis of left-sided congestive heart failure
- Clinical diagnosis of coronary artery disease
- Clinical diagnosis of cerebrovascular disease
- Clinical diagnosis of peripheral vascular disease
- Prior history of stroke or myocardial infarction
- Clinical diagnosis of obstructive sleep apnea
- Pregnancy (known, and screen with urine BHCG) or current breastfeeding
- Contraindication to Omax3[TM] use, including a history of hypersensitivity to Omax3[TM]
- Current use of high-dose fish oil capsules (defined as >1 or 2 grams/day of omega-3 fatty acids)
- Current use of Coumadin
- Elevated ALT greater than 2 times the upper limit of normal at baseline
- Congenital abnormality of the arm or hand
- Raynaud's Phenomenon
- History of radical mastectomy or removal or axillary lymph nodes
- Allergy to fish or corn oil
- Unstable angina during previous month
- End Stage Liver Disease, Cirrhosis
- For Non-COPD controls (Same Inclusion and exclusion criteria, except for inclusion, must NOT have the following:)
- Post-bronchodilator FEV1/FVC ratio >70%
- Post-bronchodilator FEV1 <65% predicted.
- Clinical diagnosis of COPD
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Medical Center
New York, New York, 10032
About this study
Chronic obstructive pulmonary disease (COPD) is currently the fourth leading cause of death in the United States. Unlike the other leading causes of death, no medical therapies currently available improve the course of disease or affect survival in COPD. Recent investigations suggest that endothelial dysfunction and chronic inflammation is fundamental to COPD. Fish oil intake improves endothelial dysfunction and lowers levels of inflammatory intermediaries which may be important in the development of COPD.
The Chronic Obstructive Pulmonary Disease Fish Oil (COD-Fish) Pilot Trial will enroll 40-45 participants with COPD. These participants will be randomized to receive omega-3 polyunsaturated fatty acid supplementation (PUFA) or placebo (containing corn oil). All participants will perform a number of noninvasive tests (including flow-mediated dilation (FMD) and pulmonary function testing) at study entry as well as every two months for a total of six months. Thirty participants who agree to it will undergo a separate procedure to collect cells from inside a forearm vein for analysis to be compared to 30 controls. The main purpose of this trial is to examine the effect of PUFA on endothelial function as measured by change in FMD in patients with COPD. We hypothesize that in subjects with COPD, treatment with PUFA will increase FMD.
Read the detailed description
Chronic obstructive pulmonary disease is abbreviated as COPD and includes both emphysema and chronic bronchitis. COPD is currently the fourth leading cause of death in the United States. Unlike most major medical diseases, the morbidity and mortality from COPD continue to rise in the US. In 2000, over 10 million Americans carried a physician diagnosis of COPD and 120,000 Americans died from this disease. Additionally, from the year 1980 to the year 2000, the number of cases of COPD among women nearly doubled and the prevalence among African Americans increased by 61%. Unlike the other leading causes of death, no medical therapies currently available improve the course of disease or affect survival in COPD. Current therapies for COPD that improve survival in COPD are limited to smoking cessation, oxygen therapy, and possibly surgery. Medical therapies such as inhalers and pills improve symptoms and reduce COPD exacerbations ("attacks"), but have not been shown to slow down the progression of the disease.
Recent investigations suggest that endothelial dysfunction and chronic inflammation is fundamental to COPD. Fish oil intake improves endothelial dysfunction and lowers levels of inflammatory intermediaries. These inflammatory intermediaries can be measured in the blood and are potentially important in the development of COPD. Large observational studies demonstrate that participants who eat high amounts of fish oil develop less COPD and have lower levels of these inflammatory intermediaries.
The Chronic Obstructive Pulmonary Disease Fish Oil (COD-Fish) Pilot Trial will enroll 40-45 participants with COPD. These participants will be randomized to receive Omax3[TM] or placebo (containing corn oil). Omax3[TM] (Cenestra Health) is a 1 gram softgel capsule containing 94.5% omega-3 fatty acids. Each participant will be taking 3 capsules of either Omax3[TM] or matching placebo. The investigators and the subjects will be blinded, meaning that neither the investigators nor the subjects will know if they are taking Omax3[TM] or placebo. All participants will perform a number of noninvasive tests at study entry as well as every two months for a total of six months. They will also undergo pulmonary function testing, flow-mediated dilation (FMD), peripheral arterial tonometry (PAT), six minute-walk tests (6MWT), blood drawing and answer questionnaire data. Thirty participants who agree to it will undergo a separate procedure to collect cells from inside a forearm vein for analysis to be compared to 30 controls. The main purpose of this trial is to examine the effect of Omax3[TM] on endothelial function as measured by change in FMD in patients with COPD. We hypothesize that in subjects with COPD, treatment with Omax3[TM] will increase FMD.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- n-3 polyunsaturated fatty acids, Placebo
- Keywords
- Clinical Trials, Randomized
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
n-3 polyunsaturated fatty acidsDietary supplement
Also called Omax-3, PUFA, Omega-3
Omax3[TM] (Cenestra Health [TM]) is a 1 g softgel capsule containing 94.5% omega-3 fatty acids. Each serving size is a 1 gram capsule, which contains 690 mg of eicosapentanoic acid (EPA) and 182 mg of docosahexanoic acid (DHA). Inactive ingredients include: Vitamin E/Tocopherol 2294 ppm (in a carrier of partially hydrogenated vegetable oils including soybean oil), gelatin, glycerol, and purified water (components of the capsule shell). The study participants will be randomized to 3 softgel capsules a day for 6 months.
PlaceboOther
3 capsules of matching corn oil placebo
| Study group | Role | What they receive |
|---|---|---|
| Placebo (corn oil) | Placebo comparator | Each participant will be taking 3 capsules of a matching placebo (corn oil). Receives: Other: Placebo |
| PUFA (Omax3) | Experimental | Omax3[TM] (Cenestra Health), or dietary supplement: n-3 polyunsaturated fatty acids, is a 1 gram softgel capsule containing 94.5% omega-3 fatty acids. Each participant will be taking 3 capsules of Omax3[TM]. Receives: Dietary Supplement: n-3 polyunsaturated fatty acids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Flow Mediated Dilation (FMD)
Measured: 6 months
Secondary outcomes (8)
Serum level of LTB4
Measured: 6 months
Serum level of TNF-alpha
Measured: 6 months
Serum level of IFN-gamma
Measured: 6 months
Difference in Pre- and Post-bronchodilator Spirometry
Measured: 6 months
Average six-minute-walk test distance
Measured: 6 months
Average St. George's Respiratory Questionnaire score
Measured: 6 months
Change in percent of Peripheral Arterial Tonometry (EndoPAT)
Measured: 4 months
Number of endothelial cell protein expression
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 posted3 Feb 2009 (estimated)
- Study startMar 2009
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Environmental Health Sciences (NIEHS)
- Responsible party
- Sponsor
- Investigators
- R Graham Barr, MD/DrPH, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00835289
- Sponsor's protocol ID
- AAAC9586
- Other IDs
- P30ES009089
- Acronym
- COD-Fish
- Status last verified
- Nov 2020
- First submitted
- 22 Oct 2008
- Last updated
- 17 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kim JS, Thomashow MA, Yip NH, Burkart KM, Lo Cascio CM, Shimbo D, Barr RG. Randomization to Omega-3 Fatty Acid Supplementation and Endothelial Function in COPD: The COD-Fish Randomized Controlled Trial. Chronic Obstr Pulm Dis. 2021 Jan;8(1):41-53. doi: 10.15326/jcopdf.8.1.2020.0132.
PubMed 33150779
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Chronic Obstructive Pulmonary Disease Fish Oil Pilot Trial
- ClinicalTrials.gov ID
- NCT00835289
- Acronym / sponsor ID
- COD-Fish / AAAC9586
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Clinical Trials, Randomized
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Institute of Environmental Health Sciences (NIEHS)
- Study start
- Mar 2009
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 3 Feb 2009 (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.
Chronic obstructive pulmonary disease (COPD) is currently the fourth leading cause of death in the United States. Unlike the other leading causes of death, no medical therapies currently available improve the course of disease or affect survival in COPD. Recent investigations suggest that endothelial dysfunction and chronic inflammation is fundamental to COPD. Fish oil intake improves endothelial dysfunction and lowers levels of inflammatory intermediaries which may be important in the development of COPD.
The Chronic Obstructive Pulmonary Disease Fish Oil (COD-Fish) Pilot Trial will enroll 40-45 participants with COPD. These participants will be randomized to receive omega-3 polyunsaturated fatty acid supplementation (PUFA) or placebo (containing corn oil). All participants will perform a number of noninvasive tests (including flow-mediated dilation (FMD) and pulmonary function testing) at study entry as well as every two months for a total of six months. Thirty participants who agree to it will undergo a separate procedure to collect cells from inside a forearm vein for analysis to be compared to 30 controls. The main purpose of this trial is to examine the effect of PUFA on endothelial function as measured by change in FMD in patients with COPD. We hypothesize that in subjects with COPD, treatment with PUFA will increase FMD.
Detailed description
Chronic obstructive pulmonary disease is abbreviated as COPD and includes both emphysema and chronic bronchitis. COPD is currently the fourth leading cause of death in the United States. Unlike most major medical diseases, the morbidity and mortality from COPD continue to rise in the US. In 2000, over 10 million Americans carried a physician diagnosis of COPD and 120,000 Americans died from this disease. Additionally, from the year 1980 to the year 2000, the number of cases of COPD among women nearly doubled and the prevalence among African Americans increased by 61%. Unlike the other leading causes of death, no medical therapies currently available improve the course of disease or affect survival in COPD. Current therapies for COPD that improve survival in COPD are limited to smoking cessation, oxygen therapy, and possibly surgery. Medical therapies such as inhalers and pills improve symptoms and reduce COPD exacerbations ("attacks"), but have not been shown to slow down the progression of the disease.
Recent investigations suggest that endothelial dysfunction and chronic inflammation is fundamental to COPD. Fish oil intake improves endothelial dysfunction and lowers levels of inflammatory intermediaries. These inflammatory intermediaries can be measured in the blood and are potentially important in the development of COPD. Large observational studies demonstrate that participants who eat high amounts of fish oil develop less COPD and have lower levels of these inflammatory intermediaries.
The Chronic Obstructive Pulmonary Disease Fish Oil (COD-Fish) Pilot Trial will enroll 40-45 participants with COPD. These participants will be randomized to receive Omax3[TM] or placebo (containing corn oil). Omax3[TM] (Cenestra Health) is a 1 gram softgel capsule containing 94.5% omega-3 fatty acids. Each participant will be taking 3 capsules of either Omax3[TM] or matching placebo. The investigators and the subjects will be blinded, meaning that neither the investigators nor the subjects will know if they are taking Omax3[TM] or placebo. All participants will perform a number of noninvasive tests at study entry as well as every two months for a total of six months. They will also undergo pulmonary function testing, flow-mediated dilation (FMD), peripheral arterial tonometry (PAT), six minute-walk tests (6MWT), blood drawing and answer questionnaire data. Thirty participants who agree to it will undergo a separate procedure to collect cells from inside a forearm vein for analysis to be compared to 30 controls. The main purpose of this trial is to examine the effect of Omax3[TM] on endothelial function as measured by change in FMD in patients with COPD. We hypothesize that in subjects with COPD, treatment with Omax3[TM] will increase FMD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo (corn oil) | Placebo comparator | Other: PlaceboEach participant will be taking 3 capsules of a matching placebo (corn oil). |
| PUFA (Omax3) | Experimental | Dietary Supplement: n-3 polyunsaturated fatty acidsOmax3[TM] (Cenestra Health), or dietary supplement: n-3 polyunsaturated fatty acids, is a 1 gram softgel capsule containing 94.5% omega-3 fatty acids. Each participant will be taking 3 capsules of Omax3[TM]. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Post-bronchodilator FEV1/FVC ratio <70%
- Post-bronchodilator FEV1 <65% predicted.
- Clinical diagnosis of COPD
- Stable medical regimen for 30 days prior to enrollment
- Age > 40 years old
Key exclusion criteria (27 listed)
- COPD exacerbation or hospitalization for COPD in the past 30 days
- Confirmed history of physician-diagnosed asthma
- History of unrelated pulmonary disease (e.g. interstitial lung disease, thromboembolic disease)
- Status-post lung transplantation or Lung volume reduction surgery (LVRS)
- Systolic blood pressure >170mmHg or<100mmHg at rest, diastolic blood pressure >100 at rest, or resting HR >120.
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 |
|---|---|---|
| n-3 polyunsaturated fatty acidsAlso: Omax-3, PUFA, Omega-3Omax3[TM] (Cenestra Health [TM]) is a 1 g softgel capsule containing 94.5% omega-3 fatty acids. Each serving size is a 1 gram capsule, which contains 690 mg of eicosapentanoic acid (EPA) and 182 mg of docosahexanoic acid (DHA). Inactive ingredients include: Vitamin E/Tocopherol 2294 ppm (in a carrier of partially hydrogenated vegetable oils including soybean oil), gelatin, glycerol, and purified water (components of the capsule shell). The study participants will be randomized to 3 softgel capsules a day for 6 months. | Dietary supplement | PUFA (Omax3) |
| Placebo3 capsules of matching corn oil placebo | Other | Placebo (corn oil) |
Primary outcome
Percent Flow Mediated Dilation (FMD)
Time frame: 6 months
8 secondary outcomes
Serum level of LTB4
Time frame: 6 months
Serum level of TNF-alpha
Time frame: 6 months
Serum level of IFN-gamma
Time frame: 6 months
Difference in Pre- and Post-bronchodilator Spirometry
Time frame: 6 months
Average six-minute-walk test distance
Time frame: 6 months
Average St. George's Respiratory Questionnaire score
Time frame: 6 months
Change in percent of Peripheral Arterial Tonometry (EndoPAT)
Time frame: 4 months
Number of endothelial cell protein expression
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 17 Nov 2020.
- Results publication: PubMed 33150779Kim JS, Thomashow MA, Yip NH, Burkart KM, Lo Cascio CM, Shimbo D, Barr RG. Randomization to Omega-3 Fatty Acid Supplementation and Endothelial Function in COPD: The COD-Fish Randomized Controlled Trial. Chronic Obstr Pulm Dis. 2021 Jan;8(1):41-53. doi: 10.15326/jcopdf.8.1.2020.0132.
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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.
R Graham Barr, MD/DrPH principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing n-3 polyunsaturated fatty acids in people with Chronic Obstructive Pulmonary Disease, run by Columbia University 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 6 inclusion and 27 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 17 Nov 2020. 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?
Percent Flow Mediated Dilation (FMD) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00835289, which also lists 1 linked publication.
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 17 Nov 2020.