Treatment of Bronchial Asthma With Borage and Echium Seed Oils

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by Brigham and Women's Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Wake Forest School of Medicine
Information provided by:
Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00806442
First received: December 9, 2008
Last updated: May 3, 2010
Last verified: May 2010
  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 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

Resource links provided by NLM:


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 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:
  • CROSSENTIAL GLA TG40
  • INCROMEGA V3
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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Recruiting
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
Wake Forest School of Medicine
Investigators
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, P50 AT002782
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
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014