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Treatment of Bronchial Asthma With Borage and Echium Seed Oils

This study has been completed.
Sponsor:
Collaborators:
Wake Forest University Health Sciences
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Elliot Israel, MD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00806442
First received: December 9, 2008
Last updated: June 6, 2017
Last verified: June 2017
  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 Drug: Borage Seed Oil and Echium Seed Oil Dietary Supplement: Corn Oil Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, 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 Elliot Israel, MD, Brigham and Women's Hospital:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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

  • Peak Flow Rate (PEFR) [ Time Frame: 6 weeks ]
    Morning Peak Flow Rate in plant seed oil vs. placebo

  • 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

  • Day-time Symptoms of Bronchial Asthma [ Time Frame: 6 weeks ]

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

    1. = Mild: Symptom did not interfere with normal daily activity or sleep
    2. = Moderate: Symptom was sufficient to interfere with normal daily activity or sleep
    3. = 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.


  • Night-time Wakenings [ Time Frame: 6 weeks ]
    Average number of night-time wakenings in plant seed oil vs. placebo

  • Urinary Leukotriene Levels [ Time Frame: 6 weeks ]
    Urinary leukotriene levels in plant seed oil vs. placebo


Enrollment: 43
Study Start Date: December 2008
Study Completion Date: August 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1: Borage Seed Oil and Echium Seed Oil
Borage/Echium plant seed oils: 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.
Drug: 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: Placebo Comparator
Placebo comparator: 9 g/day corn oil
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)
Sexes Eligible for Study:   All
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 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.
  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

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 Health Sciences
National Center for Complementary and Integrative Health (NCCIH)
Investigators
Principal Investigator: Elliot Israel, MD Brigham and Women's Hospital
  More Information

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Elliot Israel, MD, Principal Investigator, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00806442     History of Changes
Other Study ID Numbers: 2008p001696
P50AT002782 ( U.S. NIH Grant/Contract )
Study First Received: December 9, 2008
Results First Received: July 16, 2014
Last Updated: June 6, 2017

Keywords provided by Elliot Israel, MD, 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 25, 2017