Treatment of Bronchial Asthma With Borage and Echium Seed Oils

June 6, 2017 updated by: Elliot Israel, MD, Brigham and Women's Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

43

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Forced Expiratory Volume in 1 Second (FEV1)
Time Frame: 6 weeks
Forced expiratory volume in 1 second (FEV1) in plant seed oil vs. placebo
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 weeks on each treatment assignment
Peak Flow Rate (PEFR)
Time Frame: 6 weeks
Morning Peak Flow Rate in plant seed oil vs. placebo
6 weeks
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
6 weeks
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.
6 weeks
Night-time Wakenings
Time Frame: 6 weeks
Average number of night-time wakenings in plant seed oil vs. placebo
6 weeks
Urinary Leukotriene Levels
Time Frame: 6 weeks
Urinary leukotriene levels in plant seed oil vs. placebo
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brigham and Women's Hospital

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (Actual)

April 1, 2012

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

December 9, 2008

First Submitted That Met QC Criteria

December 9, 2008

First Posted (Estimate)

December 10, 2008

Study Record Updates

Last Update Posted (Actual)

July 3, 2017

Last Update Submitted That Met QC Criteria

June 6, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008p001696
  • P50AT002782 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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