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Completed

NCT Number: NCT00806442

Treatment of Bronchial Asthma With Borage and Echium Seed Oils

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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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Asthma Research Center, Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 of >=12% FEV1 with bronchodilator

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.

Treatment and study plan

Borage Seed Oil and Echium Seed Oil

Drug

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

corn oil

Dietary Supplement

9 g/day of corn oil

Primary outcomes

  1. Forced Expiratory Volume in 1 Second (FEV1)

    Time frame: 6 weeks

    Forced expiratory volume in 1 second (FEV1) in plant seed oil vs. placebo

Secondary outcomes

  1. Positive FEV1 Percent Predicted Change Among C Allele Carriers and A Homozygotes

    Time frame: 6 weeks on each treatment assignment

    Number of participants with positive change in FEV1 % predicted (>0%) among C allele carriers and A homozygotes in each arm

  2. Peak Flow Rate (PEFR)

    Time frame: 6 weeks

    Morning Peak Flow Rate in plant seed oil vs. placebo

  3. Frequency of Rescue Use of Short Acting Beta-2 Agonists

    Time frame: 6 weeks

    Average number of puffs of albuterol daily in plant seed oil vs. placebo

  4. Day-time Symptoms of Bronchial Asthma

    Time frame: 6 weeks

    Day-time symptom scores in plant seed oil vs. placebo. 0 = Absent: No symptoms

    • = Mild: Symptom did not interfere with normal daily activity or sleep
    • = Moderate: Symptom was sufficient to interfere with normal daily activity or sleep
    • = Severe: Symptom was so severe as to prevent normal daily activity or sleep

    These numbers were used for 1. Shortness of breath 2. Chest tightness 3. Wheezing 4. Cough 5. Phlegm/Mucus.

    The total score is the sum of the 5 item scores, for a range of 0-15. A higher score represents more severe symptoms. Each participant's score is the average of varying numbers of diary cards. The treatment phase visits at 6 weeks consisted of 3 weeks of diary cards with a +/- 5 day window. The baseline visits had 2 weeks of diary cards with a +/- 5 day window. The treatment phase measures are adjusted for the baseline measures.

  5. Night-time Wakenings

    Time frame: 6 weeks

    Average number of night-time wakenings in plant seed oil vs. placebo

  6. Urinary Leukotriene Levels

    Time frame: 6 weeks

    Urinary leukotriene levels in plant seed oil vs. placebo

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)
  • Wake Forest University Health Sciences

Registry information

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Dec 10, 2008
Registry last updated
Jul 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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