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Treatment of Bronchial Asthma With Borage and Echium Seed Oils
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Purpose
| Condition | Intervention | Phase |
|---|---|---|
| Bronchial Asthma | Drug: Borage Seed Oil and Echium Seed Oil Dietary Supplement: Corn Oil | Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Triple (Participant, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Treatment of Bronchial Asthma With Borage and Echium Seed Oils |
- Forced Expiratory Volume in 1 Second (FEV1) [ Time Frame: 6 weeks ]Forced expiratory volume in 1 second (FEV1) in plant seed oil vs. placebo
- Positive FEV1 Percent Predicted Change Among C Allele Carriers and A Homozygotes [ Time Frame: 6 weeks on each treatment assignment ]Number of participants with positive change in FEV1 % predicted (>0%) among C allele carriers and A homozygotes in each arm
- Peak Flow Rate (PEFR) [ Time Frame: 6 weeks ]Morning Peak Flow Rate in plant seed oil vs. placebo
- Frequency of Rescue Use of Short Acting Beta-2 Agonists [ Time Frame: 6 weeks ]Average number of puffs of albuterol daily in plant seed oil vs. placebo
- Day-time Symptoms of Bronchial Asthma [ Time Frame: 6 weeks ]
Day-time symptom scores in plant seed oil vs. placebo. 0 = Absent: No symptoms
- = Mild: Symptom did not interfere with normal daily activity or sleep
- = Moderate: Symptom was sufficient to interfere with normal daily activity or sleep
- = Severe: Symptom was so severe as to prevent normal daily activity or sleep
These numbers were used for 1. Shortness of breath 2. Chest tightness 3. Wheezing 4. Cough 5. Phlegm/Mucus.
The total score is the sum of the 5 item scores, for a range of 0-15. A higher score represents more severe symptoms. Each participant's score is the average of varying numbers of diary cards. The treatment phase visits at 6 weeks consisted of 3 weeks of diary cards with a +/- 5 day window. The baseline visits had 2 weeks of diary cards with a +/- 5 day window. The treatment phase measures are adjusted for the baseline measures.
- Night-time Wakenings [ Time Frame: 6 weeks ]Average number of night-time wakenings in plant seed oil vs. placebo
- Urinary Leukotriene Levels [ Time Frame: 6 weeks ]Urinary leukotriene levels in plant seed oil vs. placebo
| Enrollment: | 43 |
| Study Start Date: | December 2008 |
| Study Completion Date: | August 2012 |
| Primary Completion Date: | April 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1: Borage Seed Oil and Echium Seed Oil
Borage/Echium plant seed oils: 2 g/day of borage seed oil and 7 g/day of echium seed oil to provide 1.6 g/day of GLA and 0.9 g/day of SDA.
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Drug: Borage Seed Oil and Echium Seed Oil
2 g/day of borage seed oil and 7 g/day of echium seed oil to provide 1.6 g/day of GLA and 0.9 g/day of SDA.
Other Names:
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Placebo Comparator: 2: Placebo Comparator
Placebo comparator: 9 g/day corn oil
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Dietary Supplement: Corn Oil
9 g/day of corn oil
|
Detailed Description:
Leukotrienes are important in the pathogenesis of inflammation, and leukotriene modifying drugs are now an established treatment for bronchial asthma and rhinitis. Drugs that inhibit the biosynthesis of leukotrienes are likely to be more effective than the currently available drugs that antagonize a single leukotriene receptor. Dietary supplementation with gamma linolenic acid (GLA) in borage seed oil provides effective inhibition of leukotriene generation but also increases circulating free arachidonic acid (AA), which has pro-inflammatory potential. The n-3 fatty acid, eicosapentaenoic acid (EPA), prevented the conversion of GLA to AA. However, EPA is extracted from fish oil, is not well-tolerated due to its taste, and at higher doses appeared to blunt the inhibition of leukotriene biosynthesis by GLA. Stearidonic acid (SDA) is a precursor of EPA that is extracted from Echium plantagineum; it is converted to EPA in humans and it does not have the organoleptic properties of EPA.
We recently completed a dose-ranging study in which we determined the dose of SDA that is sufficient to inhibit the rise in circulating levels of arachidonic acid while maintaining effective inhibition of leukotriene generation.
The goal of the present study is to test the efficacy of dietary supplementation with GLA and SDA (provided in borage seed oil and echium seed oil) in treating bronchial asthma.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Diagnosis of bronchial asthma
- Male or female 18 years to 65 years of age
- FEV1 50 to 90% of predicted, or personal best.
- Improvement of >=12% FEV1 with bronchodilator
Exclusion Criteria:
- Pregnant or nursing
- Smoking history of > 10 pack years or active smoking within the past year.
-
Due to possible effects on leukotriene biosynthesis, use of the following asthma treatments within the preceding month will be exclusion criteria:
- leukotriene modifying drugs,
- theophylline
- oral steroids.
- dietary supplements with fatty acids or other products that may interfere with leukotriene generation.
- Treatment within the previous three months with omalizumab (monoclonal antibody directed against IgE)
- Subjects will not be permitted to take non-steroidal anti-inflammatory drugs in the week prior to any measurements of ex vivo leukotriene generation because of their effects on leukotriene biosynthesis via inhibition of prostaglandin generation.
- A history of aspirin-sensitive asthma
- Significant abnormalities in CBC, differential white cell count, renal function, and liver function, or urinalysis.
- Any serious co-morbid medical condition.
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00806442
| United States, Massachusetts | |
| Asthma Research Center, Brigham and Women's Hospital | |
| Boston, Massachusetts, United States, 02115 | |
| Principal Investigator: | Elliot Israel, MD | Brigham and Women's Hospital |
More Information
Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Elliot Israel, MD, Principal Investigator, Brigham and Women's Hospital |
| ClinicalTrials.gov Identifier: | NCT00806442 History of Changes |
| Other Study ID Numbers: |
2008p001696 P50AT002782 ( U.S. NIH Grant/Contract ) |
| Study First Received: | December 9, 2008 |
| Results First Received: | July 16, 2014 |
| Last Updated: | June 6, 2017 |
Keywords provided by Elliot Israel, MD, Brigham and Women's Hospital:
|
Asthma Fatty acids Leukotrienes Diet |
Additional relevant MeSH terms:
|
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity |
Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Borage oil Antirheumatic Agents |
ClinicalTrials.gov processed this record on September 25, 2017