Treatment of Bronchial Asthma With Borage and Echium Seed Oils
Recruitment status was Recruiting
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Purpose
| Condition | Intervention | Phase |
|---|---|---|
|
Bronchial Asthma |
Dietary Supplement: Borage Seed Oil and Echium Seed Oil Dietary Supplement: Corn Oil |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Treatment of Bronchial Asthma With Borage and Echium Seed Oils |
- FEV1 [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
- Peak flows [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
- Symptoms of bronchial asthma [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
- Frequency of rescue use of short acting beta-2 agonists [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
- Ex vivo leukotriene generation [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
- Plasma fatty acid content [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 28 |
| Study Start Date: | December 2008 |
| Estimated Study Completion Date: | March 2011 |
| Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Dietary Supplement: 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:
|
| Placebo Comparator: 2 |
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) |
| Genders Eligible for Study: | Both |
| 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 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.
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00806442
| Contact: Stefanie Dutile, BS | 1-888-99-ASTHMA | arc@partners.org | |
| Contact: Suzanne Vogt, MS | 1-888-99-ASTHMA | arc@partners.org |
| United States, Massachusetts | |
| Asthma Research Center, Brigham and Women's Hospital | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Principal Investigator: | Jonathan P Arm, MD | Brigham and Women's Hospital |
More Information
Additional Information:
Publications:
| Responsible Party: | Jonathan P. Arm, M.D., Brigham and Women's Hospital |
| ClinicalTrials.gov Identifier: | NCT00806442 History of Changes |
| Other Study ID Numbers: | 2008p001696 P50AT002782 |
| Study First Received: | December 9, 2008 |
| Last Updated: | May 3, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by 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 28, 2016