Status:
COMPLETED
The Chronic Obstructive Pulmonary Disease Fish Oil Pilot Trial
Lead Sponsor:
Columbia University
Collaborating Sponsors:
National Institute of Environmental Health Sciences (NIEHS)
Conditions:
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
40+ years
Phase:
NA
Brief 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 imp...
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 m...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00835289
Start Date
March 1 2009
End Date
August 1 2013
Last Update
November 17 2020
Active Locations (1)
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1
Columbia University Medical Center
New York, New York, United States, 10032