Status:
COMPLETED
Treatment of Bronchial Asthma With Borage and Echium Seed Oils
Lead Sponsor:
Brigham and Women's Hospital
Collaborating Sponsors:
Wake Forest University Health Sciences
National Center for Complementary and Integrative Health (NCCIH)
Conditions:
Bronchial Asthma
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief 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.
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT00806442
Start Date
December 1 2008
End Date
August 1 2012
Last Update
July 3 2017
Active Locations (1)
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1
Asthma Research Center, Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115