Phase 2
Completed N=39
Treatment of Bronchial Asthma With Borage and Echium Seed Oils
Source: ClinicalTrials.gov NCT00806442 ↗Enrolled (actual)
39
Serious AEs
1.2%
Results posted
Jul 2017
Primary outcomePrimary: Forced Expiratory Volume in 1 Second (FEV1) — 2.31; 2.25 liters
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Forced Expiratory Volume in 1 Second (FEV1) |
2.31; 2.25 | — |
| SECONDARY Positive FEV1 Percent Predicted Change Among C Allele Carriers and A Homozygotes |
6; 2; 11; 10 | — |
| SECONDARY Peak Flow Rate (PEFR) |
337.13; 339.34 | — |
| SECONDARY Frequency of Rescue Use of Short Acting Beta-2 Agonists |
0.69; 0.50 | — |
| SECONDARY Day-time Symptoms of Bronchial Asthma |
2.51; 1.61 | — |
| SECONDARY Night-time Wakenings |
0.16; 0.13 | — |
| SECONDARY Urinary Leukotriene Levels |
0.101; 0.088 | — |
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT00806442). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.