Borage and Echium Seed Oils for Asthma
Borage
Treatment of Bronchial Asthma With Borage and Echium Seed Oils
1 other identifier
interventional
62
1 country
1
Brief Summary
This study plans to look at whether borage and echium seed oils (natural oils from two plants) help decrease asthma symptoms and affect cells involved in inflammation. The investigators also want to look at how these plant oils decrease the generation of inflammatory cells in people with asthma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 asthma
Started Feb 2013
Typical duration for phase_3 asthma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 9, 2012
CompletedFirst Posted
Study publicly available on registry
March 22, 2012
CompletedStudy Start
First participant enrolled
February 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedResults Posted
Study results publicly available
August 9, 2017
CompletedApril 9, 2018
April 1, 2018
2.2 years
March 9, 2012
February 15, 2017
April 6, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Cellular Changes That Occur With Borage and Echium Seed Oil Supplementation
Primary outcome measures will be changes in the generation of LTC4 production by granulocytes. This was calculated by the difference between the amount produced at the start of each arm and at the end of each arm (i.e., two values were obtained in each arm and used to calculate the difference, and the differences were compared as a delta-delta).
Assessed at 2, 8, 14, and 20 weeks
Change in LTB4 Production
Primary outcome measures will be changes in the generation of LTB4 production by granulocytes. This was calculated by the difference between the amount produced at the start of each arm and at the end of each arm (i.e., two values were obtained in each arm and used to calculate the difference, and the differences were compared as a delta-delta). A negative number implies that the level of LTB4 produced by granulocytes at the end of the arm was less than the amount produced at the start of the arm, while a positive number means that more was generated at the end than at the beginning.
At 2, 8, 14, and 20 weeks
Secondary Outcomes (8)
Measure of DHA in Cell Pellets
Assessed at 2, 8, 14, and 20 weeks
Lung Function
Assessed at 2, 8, 14, and 20 weeks
Plasma Level of Gamma Linolenic Acid (GLA)
Measurements obtained at 2, 8, 14, and 20 weeks
Number of Subjects Bearing a Polymorphic Variant of LTC4 Synthase
two weeks
Asthma Control
Assessed at 2, 8, 14, and 20 weeks
- +3 more secondary outcomes
Study Arms (2)
Active Borage and Echium Seed Oils
EXPERIMENTALBorage and echium oil capsules administered daily for six weeks, then a 6 week washout period, followed by ingestion of placebo (corn oil capsules) daily for 6 weeks.
Corn oil pills
EXPERIMENTALCorn oil capsules daily for six weeks, then a 6 week washout period, followed by ingestion of Borage and echium oil capsules daily for 6 weeks.
Interventions
4.0 g/day borage seed oil and 7.0 g/day echium seed oil. Pills will be taken three times per day for six weeks.
Corn oils pills will be taken three times per day for six weeks.
Eligibility Criteria
You may qualify if:
- Male or female 18 years to 65 years of age
- Stable physician diagnosed asthma with FEV1 of greater than 50% of predicted but less than 90% of predicted or less than 90% of known best and an asthma control questionnaire(ACQ) \< 1.5.
You may not qualify if:
- Pregnant or nursing
- Smoking history of \> 10 pack years or active smoking within the past year.
- LT modifying drugs (zileuton, montelukast, zafirlukast)
- theophylline
- oral steroids
- dietary supplements with fatty acids or other products that may interfere with LT 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 LT generation because of their effects on LT biosynthesis via inhibition of prostaglandin generation.
- Significant abnormalities in CBC, differential white cell count, renal function, and liver function, or urinalysis.
- No subjects will have any serious co-morbid medical condition.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Brigham and Women's Hospitallead
- Wake Forest Universitycollaborator
Study Sites (1)
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Joshua Boyce
- Organization
- Brigham and Women's Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Joshua Boyce, MD
Brigham and Women's Hospital
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Medicine
Study Record Dates
First Submitted
March 9, 2012
First Posted
March 22, 2012
Study Start
February 1, 2013
Primary Completion
May 1, 2015
Study Completion
May 1, 2015
Last Updated
April 9, 2018
Results First Posted
August 9, 2017
Record last verified: 2018-04