Borage and Echium Seed Oils for Asthma

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Brigham and Women's Hospital
Sponsor:
Collaborator:
Wake Forest School of Medicine
Information provided by (Responsible Party):
Joshua Boyce, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01560988
First received: March 9, 2012
Last updated: July 30, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Asthma
Drug: Borage and Echium Seed Oils
Drug: Corn oil pills
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
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 Brigham and Women's Hospital:

Primary Outcome Measures:
  • Cellular changes that occur with borage and echium seed oil supplementation [ Time Frame: Assessed at 2, 8, 14, and 20 weeks ] [ Designated as safety issue: No ]
    Primary outcome measures will be changes in the generation of LTB4 by neutrophils; changes in LTC4 production by basophils; changes in the production of LTB4 and LTC4 by monocytes; changes in expression levels of cPLA2, 5-LO, FLAP, LTC4S, and LTA4H by these cells; changes in the production of cytokines by basophils and monocytes and the expression and function of PI-3 kinaisoforms (Aim 1); changes in the generation of PGE1 vs. PGE2 and thromboxane and PPARγ expression by monocytes (Aim 2).


Secondary Outcome Measures:
  • Measure of fatty acid levels in blood [ Time Frame: Assessed at 2, 8, 14, and 20 weeks ] [ Designated as safety issue: No ]
    Secondary outcome measures include changes in concentrations of essential fatty acids in whole blood (as a measure of compliance).

  • Asthma Control [ Time Frame: Assessed at 0, 2, 5, 8, 14, 17, and 20 weeks ] [ Designated as safety issue: No ]
    Changes in asthma control will be assessed via the Asthma Control Questionnaire at each visit.

  • Lung Function [ Time Frame: Assessed at 0, 2, 5, 8, 14, 17, and 20 weeks ] [ Designated as safety issue: No ]
    Changes in lung function will be assessed via spirometry at each visit.

  • Genotype specific variation in response to borage and echium oils [ Time Frame: At 2 weeks ] [ Designated as safety issue: No ]
    All individuals will be genotyped at the LTC4S locus. At the end of the study, the investigators will use the information to determine whether the individuals with at least one copy of the C variant of LTC4S display higher levels of lung function while on borage/echium than on placebo and whether their levels of LTC4S protein and mRNA expression in CD14+ monocytes and peripheral blood eosinophils are higher than in individuals with two A alleles.


Estimated Enrollment: 60
Study Start Date: February 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active Borage and Echium Seed Oils
Borage and echium seed oils will be taken for six weeks.
Drug: Borage and Echium Seed Oils
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.
Placebo Comparator: Corn oil pills
Corn oil pills will be taken for six weeks.
Drug: Corn oil pills
Corn oils pills will be taken three times per day for six weeks.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female 18 years to 65 years of age
  2. Stable 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.
  3. Improvement in FEV1 > 12% after administration of a beta-2 agonist.

Exclusion Criteria:

  1. Pregnant or nursing
  2. Smoking history of > 10 pack years or active smoking within the past year.
  3. Due to possible effects on LT biosynthesis, use of the following asthma treatments within the preceding month will be exclusion criteria:

    • LT modifying drugs (zileuton, montelukast, zafirlukast)
    • theophylline
    • oral steroids
    • dietary supplements with fatty acids or other products that may interfere with LT generation.
  4. Treatment within the previous three months with omalizumab (monoclonal antibody directed against IgE)
  5. 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.
  6. A history of aspirin-sensitive asthma will be an exclusion criterion as the effects of GLA/SDA on prostanoid biosynthesis have not been adequately elucidated.
  7. Significant abnormalities in CBC, differential white cell count, renal function, and liver function, or urinalysis.
  8. No subjects will have 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: NCT01560988

Contacts
Contact: Kyle Nelson, BS 617-732-8630

Locations
United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Kyle Nelson    617-732-8630    kfnelson@partners.org   
Principal Investigator: Joshua Boyce, MD         
Sponsors and Collaborators
Brigham and Women's Hospital
Wake Forest School of Medicine
Investigators
Principal Investigator: Joshua Boyce, MD Brigham and Women's Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: Joshua Boyce, Professor of Medicine, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01560988     History of Changes
Other Study ID Numbers: 2010p002041
Study First Received: March 9, 2012
Last Updated: July 30, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Brigham and Women's Hospital:
Asthma
Borage
Echium
Botanical

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on September 30, 2014