A Phase 1/2 interventional study of Borage Seed Oil and Echium Seed Oil and Corn Oil in Bronchial Asthma, sponsored by Brigham and Women's Hospital. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-07-03.
Sponsored by Brigham and Women's Hospital · Phase 1/2, Interventional, and Treatment
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.
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.
3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.
This study's enrollment of 43 is below the median of 83 across 2,752 interventional studies indexed under Asthma.
Browse Asthma studies →Brigham and Women's Hospital is the lead sponsor of 1,236 studies on the registry; 224 are open to participants now.
Of its 116 completed or terminated interventional studies of FDA-regulated products, 64 (55%) have results posted.
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Exclusion Criteria:
Due to possible effects on leukotriene biosynthesis, use of the following asthma treatments within the preceding month will be exclusion criteria:
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
Placebo comparator: 9 g/day corn oil
Dietary Supplement: Corn 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.
Also known as: CROSSENTIAL GLA TG40, INCROMEGA V3
9 g/day of corn oil
Forced Expiratory Volume in 1 Second (FEV1)
Forced expiratory volume in 1 second (FEV1) in plant seed oil vs. placebo
Time frame: 6 weeks
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
Time frame: 6 weeks on each treatment assignment
Peak Flow Rate (PEFR)
Morning Peak Flow Rate in plant seed oil vs. placebo
Time frame: 6 weeks
Frequency of Rescue Use of Short Acting Beta-2 Agonists
Average number of puffs of albuterol daily in plant seed oil vs. placebo
Time frame: 6 weeks
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.
Time frame: 6 weeks
Night-time Wakenings
Average number of night-time wakenings in plant seed oil vs. placebo
Time frame: 6 weeks
Urinary Leukotriene Levels
Urinary leukotriene levels in plant seed oil vs. placebo
Time frame: 6 weeks
| Milestone | 1 - Borage Seed Oil and Echium Seed Oil, Then Placebo | 2 - Placebo, Then Borage Seed Oil and Echium Seed Oil |
|---|---|---|
| Started | 18 | 21 |
| First intervention (3 wks) | 18 | 21 |
| Washout (3 wks) | 15 | 14 |
| Second intervention (3 wks) | 15 | 14 |
| Completed | 14 | 14 |
| Not completed | 4 | 7 |
| Withdrew: Lost to follow-up | 3 | 2 |
| Withdrew: Withdrawal by subject | 1 | 5 |
Forced expiratory volume in 1 second (FEV1) in plant seed oil vs. placebo
| liters | Plant Seed Oil | Placebo |
|---|---|---|
| Forced Expiratory Volume in 1 Second (FEV1) | 2.31 (2.22 to 2.39) | 2.25 (2.17 to 2.34) |
Number of participants with positive change in FEV1 % predicted (\>0%) among C allele carriers and A homozygotes in each arm
| Participants | Plant Seed Oil | Placebo |
|---|---|---|
| C-allele Carriers | 6 | 2 |
| A Homozygotes | 11 | 10 |
Morning Peak Flow Rate in plant seed oil vs. placebo
| liters/minute | Plant Seed Oil | Placebo |
|---|---|---|
| Peak Flow Rate (PEFR) | 337.13 (328.43 to 345.82) | 339.34 (330.65 to 348.04) |
Average number of puffs of albuterol daily in plant seed oil vs. placebo
| Avg number of puffs of albuterol daily | Plant Seed Oil | Placebo |
|---|---|---|
| Frequency of Rescue Use of Short Acting Beta-2 Agonists | 0.69 (0.42 to 0.97) | 0.50 (0.23 to 0.78) |
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.
| units on a scale | Plant Seed Oil | Placebo |
|---|---|---|
| Day-time Symptoms of Bronchial Asthma | 2.51 (1.79 to 3.22) | 1.61 (0.90 to 2.33) |
Average number of night-time wakenings in plant seed oil vs. placebo
| average number of night-time wakenings | Plant Seed Oil | Placebo |
|---|---|---|
| Night-time Wakenings | 0.16 (0.05 to 0.27) | 0.13 (0.02 to 0.23) |
Urinary leukotriene levels in plant seed oil vs. placebo
| ng/ml | Plant Seed Oil | Placebo |
|---|---|---|
| Urinary Leukotriene Levels | 0.101 (0.085 to 0.117) | 0.088 (0.072 to 0.105) |
Collected over Adverse events data were collected for one year.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Plant Seed Oil | — | 0/28 (0%) | 13/28 (46.4%) |
| Placebo | — | 0/28 (0%) | 14/28 (50%) |
| Washout After Plant Seed Oil | — | 1/14 (7.1%) | 6/14 (42.9%) |
| Washout After Placebo | — | 0/14 (0%) | 5/14 (35.7%) |
| Event | Plant Seed Oil | Placebo | Washout After Plant Seed Oil | Washout After Placebo |
|---|---|---|---|---|
| WheezeRespiratory, thoracic and mediastinal disorders | 0/28 | 0/28 | 1/14 | 0/14 |
| Event | Plant Seed Oil | Placebo | Washout After Plant Seed Oil | Washout After Placebo |
|---|---|---|---|---|
| Upper Respiratory InfectionRespiratory, thoracic and mediastinal disorders | 9/28 | 7/28 | 4/14 | 2/14 |
| sore throatRespiratory, thoracic and mediastinal disorders | 0/28 | 2/28 | 2/14 | 0/14 |
| cough, chest tightnessRespiratory, thoracic and mediastinal disorders | 3/28 | 0/28 | 0/14 | 1/14 |
| Drop in HemoglobinBlood and lymphatic system disorders | 0/28 | 0/28 | 1/14 | 0/14 |
| stomach acheGastrointestinal disorders | 0/28 | 2/28 | 0/14 | 0/14 |
| urticariaImmune system disorders | 0/28 | 0/28 | 0/14 | 1/14 |
| candidiasisInfections and infestations | 0/28 | 0/28 | 0/14 | 1/14 |
| worsening asthma symptomsRespiratory, thoracic and mediastinal disorders | 0/28 | 1/28 | 1/14 | 0/14 |
| bronchitisRespiratory, thoracic and mediastinal disorders | 0/28 | 0/28 | 0/14 | 1/14 |
| drop in hematocritBlood and lymphatic system disorders | 1/28 | 0/28 | 0/14 | 0/14 |
| Age, Customized(years) | All Study Particpants |
|---|---|
| Age | 43 (22 to 64) |
| Age, Customized(Participants) | All Study Particpants |
|---|---|
| Age Category — <=18 years | 0 |
| Age Category — Between 18 and 65 years | 39 |
| Age Category — >=65 years | 0 |
| Sex/Gender, Customized(Participants) | All Study Particpants |
|---|---|
| Gender — Female | 27 |
| Gender — Male | 12 |
| Region of Enrollment(participants) | All Study Particpants |
|---|---|
| United States | 39 |
This study is completed, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.
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