View Clinical Trial (Medical Research Study)
Treatment of Bronchial Asthma With Borage and Echium Seed Oils
| City: |
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Boston |
| State: |
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Massachusetts |
| Zip Code: |
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02115 |
| Conditions: |
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Bronchial Asthma |
| Purpose: |
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The aim of this trial is to determine the efficacy of a combination of two botanicals oils,
borage seed oil and echium seed oil, as a potential treatment for bronchial asthma.
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| Study Summary: |
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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.
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| Criteria: |
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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 in FEV1 > 12% after administration of a beta-2 agonist.
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.
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| NCT ID: |
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NCT00806442 |
| Primary Contact: |
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Principal Investigator
Jonathan P Arm, MD
Brigham and Women's Hospital
Stefanie Dutile, BS
Phone: 1-888-99-ASTHMA
Email: arc@partners.org
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| Backup Contact: |
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Email: arc@partners.org
Suzanne Vogt, MS
Phone: 1-888-99-ASTHMA
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| Location Contact: |
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Boston, Massachusetts 02115
United States
There is no listed contact information for this specific location.
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 23, 2013 |
| Modifications to this listing: |
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