Chronic Obstructive Pulmonary Disease Clinical Trial
— COD-FishOfficial title:
The Chronic Obstructive Pulmonary Disease Fish Oil Pilot Trial
Verified date | November 2020 |
Source | Columbia University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 40 |
Est. completion date | August 2013 |
Est. primary completion date | August 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 40 Years and older |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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 - 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 |
Country | Name | City | State |
---|---|---|---|
United States | Columbia University Medical Center | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Columbia University | National Institute of Environmental Health Sciences (NIEHS) |
United States,
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. 2020 Nov 2. doi: 10.15326/jc — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percent Flow Mediated Dilation (FMD) | 6 months | ||
Secondary | Serum level of LTB4 | 6 months | ||
Secondary | Serum level of TNF-alpha | 6 months | ||
Secondary | Serum level of IFN-gamma | 6 months | ||
Secondary | Difference in Pre- and Post-bronchodilator Spirometry | 6 months | ||
Secondary | Average six-minute-walk test distance | 6 months | ||
Secondary | Average St. George's Respiratory Questionnaire score | 6 months | ||
Secondary | Change in percent of Peripheral Arterial Tonometry (EndoPAT) | 4 months | ||
Secondary | Number of endothelial cell protein expression | 6 months |
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