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Bronchial AsthmaPhase 1/2NCT00806442

Treatment of Bronchial Asthma With Borage and Echium Seed Oils

A Phase 1/2 study testing Borage Seed Oil and Echium Seed Oil and Corn Oil in people with Bronchial Asthma, run by Brigham and Women's Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Bronchial Asthma
What is being tested?
Borage Seed Oil and Echium Seed Oil and Corn Oil
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
43 participants
Where
1 siteUnited States
Study dates
Dec 2008to Aug 2012
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 12Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Asthma Research Center, Brigham and Women's Hospital

    Boston, Massachusetts, 02115

Other trials in United States

About this study

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.

Read the 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.

Being tested
Borage Seed Oil and Echium Seed Oil, Corn Oil
Keywords
Asthma, Fatty acids, Leukotrienes, Diet
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Borage Seed Oil and Echium Seed OilDrug

    Also called CROSSENTIAL GLA TG40, INCROMEGA V3

    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.

  • Corn OilDietary supplement

    9 g/day of corn oil

Study groups in NCT00806442
Study groupRoleWhat they receive
1: Borage Seed Oil and Echium Seed OilExperimentalBorage/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.
Receives: Drug: Borage Seed Oil and Echium Seed Oil
2: Placebo ComparatorPlacebo comparatorPlacebo comparator: 9 g/day corn oil
Receives: Dietary Supplement: Corn Oil

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Forced Expiratory Volume in 1 Second (FEV1)

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

    Measured: 6 weeks

Secondary outcomes (6)

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

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

    Measured: 6 weeks on each treatment assignment

  2. Peak Flow Rate (PEFR)

    Morning Peak Flow Rate in plant seed oil vs. placebo

    Measured: 6 weeks

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

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

    Measured: 6 weeks

  4. Day-time Symptoms of Bronchial Asthma

    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.

    Measured: 6 weeks

  5. Night-time Wakenings

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

    Measured: 6 weeks

  6. Urinary Leukotriene Levels

    Urinary leukotriene levels in plant seed oil vs. placebo

    Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Dec 2008 (estimated)
  2. Study startDec 2008
  3. Primary completionApr 2012
  4. Study completionAug 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
43 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00806442
Sponsor's protocol ID
2008p001696
Other IDs
P50AT002782
Status last verified
Jun 2017
First submitted
9 Dec 2008
Last updated
3 Jul 2017
Data monitoring committee
No

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. doi: 10.1093/ajcn/77.5.1140.

    PubMed 12716664

  • 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.

    PubMed 8609415

  • 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. doi: 10.1093/jn/127.8.1435.

    PubMed 9237935

  • 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. doi: 10.1093/jn/130.8.1925.

    PubMed 10917903

  • 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. doi: 10.1016/s0149-2918(03)80116-9.

    PubMed 12852710

  • 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. doi: 10.1016/s0149-2918(03)80117-0.

    PubMed 12852711

  • Kazani S, Arm JP, Boyce J, Chhay H, Dutile S, Wechsler ME, Govindarajulu U, Ivester P, Ainsworth HC, Sergeant S, Chilton FH, Israel E. LTC4 synthase polymorphism modifies efficacy of botanical seed oil combination in asthma. Springerplus. 2014 Nov 6;3:661. doi: 10.1186/2193-1801-3-661. eCollection 2014.

    PubMed 25485197

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Borage Seed Oil and Echium Seed Oil and Corn Oil in people with Bronchial Asthma, run by Brigham and Women's Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Forced Expiratory Volume in 1 Second (FEV1) (time frame: 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00806442, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2017.

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