Treatment of Bronchial Asthma With Borage and Echium Seed Oils

Bronchial Asthma Clinical Trial

Official title:

Treatment of Bronchial Asthma With Borage and Echium Seed Oils

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00806442
• Other study ID #: 2008p001696
• Secondary ID: P50AT002782
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: December 9, 2008
• Last updated: May 3, 2010
• Start date: December 2008
• Est. completion date: March 2011

Study information

• Verified date: May 2010
• Source: Brigham and Women's Hospital
• Contact: Stefanie Dutile, BS
• Phone: 1-888-99-ASTHMA
• Email: arc[@]partners.org
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 28
• Est. completion date: March 2011
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma
• Bronchial Asthma

Intervention

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.
• Corn Oil
9 g/day of corn oil

Locations

Country	Name	City	State
United States	Asthma Research Center, Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	Wake Forest University

Country where clinical trial is conducted

United States, 

References & Publications (6)

Barham JB, Edens MB, Fonteh AN, Johnson MM, Easter L, Chilton FH. Addition of eicosapentaenoic acid to gamma-linolenic acid-supplemented diets prevents serum arachidonic acid accumulation in humans. J Nutr. 2000 Aug;130(8):1925-31. — View Citation

Chilton-Lopez, Surette ME, Swan DD, Fonteh AN, Johnson MM, Chilton FH. Metabolism of gammalinolenic acid in human neutrophils. J Immunol. 1996 Apr 15;156(8):2941-7. — View Citation

James MJ, Ursin VM, Cleland LG. Metabolism of stearidonic acid in human subjects: comparison with the metabolism of other n-3 fatty acids. Am J Clin Nutr. 2003 May;77(5):1140-5. — View Citation

Johnson MM, Swan DD, Surette ME, Stegner J, Chilton T, Fonteh AN, Chilton FH. Dietary supplementation with gamma-linolenic acid alters fatty acid content and eicosanoid production in healthy humans. J Nutr. 1997 Aug;127(8):1435-44. — View Citation

Surette ME, Koumenis IL, Edens MB, Tramposch KM, Chilton FH. Inhibition of leukotriene synthesis, pharmacokinetics, and tolerability of a novel dietary fatty acid formulation in healthy adult subjects. Clin Ther. 2003 Mar;25(3):948-71. — View Citation

Surette ME, Koumenis IL, Edens MB, Tramposch KM, Clayton B, Bowton D, Chilton FH. Inhibition of leukotriene biosynthesis by a novel dietary fatty acid formulation in patients with atopic asthma: a randomized, placebo-controlled, parallel-group, prospective trial. Clin Ther. 2003 Mar;25(3):972-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FEV1		6 weeks	No
Primary	Peak flows		6 weeks	No
Secondary	Symptoms of bronchial asthma		6 weeks	No
Secondary	Frequency of rescue use of short acting beta-2 agonists		6 weeks	No
Secondary	Ex vivo leukotriene generation		6 weeks	No
Secondary	Plasma fatty acid content		6 weeks	No

External Links

•   Asthma Research Center, Brigham and Women's Hospital