Treatment of Bronchial Asthma With Borage and Echium Seed Oils - Full Text View

Sponsors and Collaborators:	Brigham and Women's Hospital Wake Forest University
Information provided by:	Brigham and Women's Hospital
ClinicalTrials.gov Identifier:	NCT00806442

Purpose

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.

Condition	Intervention	Phase
Bronchial Asthma	Dietary Supplement: Borage Seed Oil and Echium Seed Oil Dietary Supplement: Corn Oil	Phase I Phase II

MedlinePlus related topics: Asthma Dietary Supplements

Drug Information available for: Borage oil

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study
Official Title:	Treatment of Bronchial Asthma With Borage and Echium Seed Oils

Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:

FEV1 [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Peak flows [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 2010
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	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.
2: Placebo Comparator	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
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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 Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00806442

Contacts

Contact: Stefanie Dutile, BS	1-888-99-ASTHMA	arc@partners.org
Contact: Suzanne Vogt, MS	1-888-99-ASTHMA	arc@partners.org

Locations

United States, Massachusetts
Asthma Research Center, Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115

Sponsors and Collaborators

Brigham and Women's Hospital

Wake Forest University

Investigators

Principal Investigator:

Jonathan P Arm, MD

Brigham and Women's Hospital

More Information

Center for Botanical Lipids at Wake Forest University This link exits the ClinicalTrials.gov site

Asthma Research Center, Brigham and Women's Hospital This link exits the ClinicalTrials.gov site

Publications:

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.

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.

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.

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.

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.

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.

Responsible Party:	Brigham and Women's Hospital ( Jonathan P. Arm, M.D. )
Study ID Numbers:	2008p001696, P50 AT002782
Study First Received:	December 9, 2008
Last Updated:	December 9, 2008
ClinicalTrials.gov Identifier:	NCT00806442
Health Authority:	United States: Food and Drug Administration

Keywords provided by Brigham and Women's Hospital:

Asthma
Fatty acids
Leukotrienes
Diet

Study placed in the following topic categories:

Borage oil
Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases

Lung Diseases
Hypersensitivity, Immediate
Asthma
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Immune System Diseases
Bronchial Diseases
Therapeutic Uses
Antirheumatic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009