Trial Outcomes & Findings for Treatment of Bronchial Asthma With Borage and Echium Seed Oils (NCT NCT00806442)

NCT ID: NCT00806442

Last Updated: 2017-07-03

Results Overview

Forced expiratory volume in 1 second (FEV1) in plant seed oil vs. placebo

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 43 participants
• Primary outcome timeframe: 6 weeks
• Results posted on: 2017-07-03

Participant Flow

43 subjects were enrolled and signed consent; however, only 39 were randomized into a treatment group. 3 subjects screen failed and 1 subject was lost to follow up prior to randomization.

Participant milestones

Measure	1 - Borage Seed Oil and Echium Seed Oil, Then Placebo Borage/Echium plant seed oils: 6.0 g/day borage seed oil and 6.0 g/day echium seed oil) (containing totals of \~ 1.7 g/day of GLA and 0.7 g/day of SDA) 3x day for 3 weeks followed a 3-week washout period, then Placebo (11 g/day corn oil) 3x day for 3 weeks.	2 - Placebo, Then Borage Seed Oil and Echium Seed Oil Placebo (11 g of corn oil/day) 3x day for 3 weeks followed by a 3-week washout period, then Borage/Echium plant seed oils: 6.0 g/day borage seed oil and 6.0 g/day echium seed oil) (containing totals of \~ 1.7 g/day of GLA and 0.7 g/day of SDA) 3x day for 3 weeks.
Overall Study STARTED	18	21
Overall Study First Intervention (3 Wks)	18	21
Overall Study Washout (3 Wks)	15	14
Overall Study Second Intervention (3 Wks)	15	14
Overall Study COMPLETED	14	14
Overall Study NOT COMPLETED	4	7

Reasons for withdrawal

Measure	1 - Borage Seed Oil and Echium Seed Oil, Then Placebo Borage/Echium plant seed oils: 6.0 g/day borage seed oil and 6.0 g/day echium seed oil) (containing totals of \~ 1.7 g/day of GLA and 0.7 g/day of SDA) 3x day for 3 weeks followed a 3-week washout period, then Placebo (11 g/day corn oil) 3x day for 3 weeks.	2 - Placebo, Then Borage Seed Oil and Echium Seed Oil Placebo (11 g of corn oil/day) 3x day for 3 weeks followed by a 3-week washout period, then Borage/Echium plant seed oils: 6.0 g/day borage seed oil and 6.0 g/day echium seed oil) (containing totals of \~ 1.7 g/day of GLA and 0.7 g/day of SDA) 3x day for 3 weeks.
Overall Study Lost to Follow-up	3	2
Overall Study Withdrawal by Subject	1	5

Baseline Characteristics

Treatment of Bronchial Asthma With Borage and Echium Seed Oils

Baseline characteristics by cohort

Measure	All Study Particpants n=39 Participants Includes patients scheduled to receive Borage and Echium seed oil first and participants scheduled to receive placebo first.
Age, Customized Age	43 years n=5 Participants
Age, Customized Age Category · <=18 years	0 Participants n=5 Participants
Age, Customized Age Category · Between 18 and 65 years	39 Participants n=5 Participants
Age, Customized Age Category · >=65 years	0 Participants n=5 Participants
Sex/Gender, Customized Gender · Female	27 Participants n=5 Participants
Sex/Gender, Customized Gender · Male	12 Participants n=5 Participants
Region of Enrollment United States	39 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 weeks

Population: Includes participants that completed the study.

Forced expiratory volume in 1 second (FEV1) in plant seed oil vs. placebo

Outcome measures

Measure	Plant Seed Oil n=28 Participants Borage/Echium plant seed oils: 6.0 g/day borage seed oil and 6.0 g/day echium seed oil) (containing totals of \~ 1.7 g/day of GLA and 0.7 g/day of SDA)	Placebo n=28 Participants Placebo (11 g of corn oil/day)
Forced Expiratory Volume in 1 Second (FEV1)	2.31 liters Interval 2.22 to 2.39	2.25 liters Interval 2.17 to 2.34

SECONDARY outcome

Timeframe: 6 weeks on each treatment assignment

Population: Patients who are C allele carriers or A homozygotes

Number of participants with positive change in FEV1 % predicted (>0%) among C allele carriers and A homozygotes in each arm

Outcome measures

Measure	Plant Seed Oil n=28 Participants Borage/Echium plant seed oils: 6.0 g/day borage seed oil and 6.0 g/day echium seed oil) (containing totals of \~ 1.7 g/day of GLA and 0.7 g/day of SDA)	Placebo n=28 Participants Placebo (11 g of corn oil/day)
Positive FEV1 Percent Predicted Change Among C Allele Carriers and A Homozygotes C-allele Carriers	6 Participants	2 Participants
Positive FEV1 Percent Predicted Change Among C Allele Carriers and A Homozygotes A Homozygotes	11 Participants	10 Participants

SECONDARY outcome

Timeframe: 6 weeks

Morning Peak Flow Rate in plant seed oil vs. placebo

Outcome measures

Measure	Plant Seed Oil n=28 Participants Borage/Echium plant seed oils: 6.0 g/day borage seed oil and 6.0 g/day echium seed oil) (containing totals of \~ 1.7 g/day of GLA and 0.7 g/day of SDA)	Placebo n=28 Participants Placebo (11 g of corn oil/day)
Peak Flow Rate (PEFR)	337.13 liters/minute Interval 328.43 to 345.82	339.34 liters/minute Interval 330.65 to 348.04

SECONDARY outcome

Timeframe: 6 weeks

Population: one participant is missing some data on this measure

Average number of puffs of albuterol daily in plant seed oil vs. placebo

Outcome measures

Measure	Plant Seed Oil n=27 Participants Borage/Echium plant seed oils: 6.0 g/day borage seed oil and 6.0 g/day echium seed oil) (containing totals of \~ 1.7 g/day of GLA and 0.7 g/day of SDA)	Placebo n=27 Participants Placebo (11 g of corn oil/day)
Frequency of Rescue Use of Short Acting Beta-2 Agonists	0.69 Avg number of puffs of albuterol daily Interval 0.42 to 0.97	0.50 Avg number of puffs of albuterol daily Interval 0.23 to 0.78

SECONDARY outcome

Timeframe: 6 weeks

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.

Outcome measures

Measure	Plant Seed Oil n=28 Participants Borage/Echium plant seed oils: 6.0 g/day borage seed oil and 6.0 g/day echium seed oil) (containing totals of \~ 1.7 g/day of GLA and 0.7 g/day of SDA)	Placebo n=28 Participants Placebo (11 g of corn oil/day)
Day-time Symptoms of Bronchial Asthma	2.51 units on a scale Interval 1.79 to 3.22	1.61 units on a scale Interval 0.9 to 2.33

SECONDARY outcome

Timeframe: 6 weeks

Population: one participant is missing some night-time wakening data

Average number of night-time wakenings in plant seed oil vs. placebo

Outcome measures

Measure	Plant Seed Oil n=27 Participants Borage/Echium plant seed oils: 6.0 g/day borage seed oil and 6.0 g/day echium seed oil) (containing totals of \~ 1.7 g/day of GLA and 0.7 g/day of SDA)	Placebo n=27 Participants Placebo (11 g of corn oil/day)
Night-time Wakenings	0.16 average number of night-time wakenings Interval 0.05 to 0.27	0.13 average number of night-time wakenings Interval 0.02 to 0.23

SECONDARY outcome

Timeframe: 6 weeks

Population: one participant was missing some urinary leukotriene data

Urinary leukotriene levels in plant seed oil vs. placebo

Outcome measures

Measure	Plant Seed Oil n=27 Participants Borage/Echium plant seed oils: 6.0 g/day borage seed oil and 6.0 g/day echium seed oil) (containing totals of \~ 1.7 g/day of GLA and 0.7 g/day of SDA)	Placebo n=27 Participants Placebo (11 g of corn oil/day)
Urinary Leukotriene Levels	0.101 ng/ml Interval 0.085 to 0.117	0.088 ng/ml Interval 0.072 to 0.105

Adverse Events

Plant Seed Oil

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Washout After Plant Seed Oil

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Washout After Placebo

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Measure	Plant Seed Oil n=28 participants at risk Borage/Echium plant seed oils: 6.0 g/day borage seed oil and 6.0 g/day echium seed oil) (containing totals of \~ 1.7 g/day of GLA and 0.7 g/day of SDA)	Placebo n=28 participants at risk Placebo (11 g of corn oil/day)	Washout After Plant Seed Oil n=14 participants at risk Washout period between first (plant seed oil) and second (placebo) treatment assignments	Washout After Placebo n=14 participants at risk Washout period between first (placebo) and second (plant seed oil) treatment assignments
Respiratory, thoracic and mediastinal disorders Wheeze	0.00% 0/28 • Adverse events data were collected for one year. Adverse events data were collected for one year, from the time of first patient enrollment to the last date of adverse event resolution.	0.00% 0/28 • Adverse events data were collected for one year. Adverse events data were collected for one year, from the time of first patient enrollment to the last date of adverse event resolution.	7.1% 1/14 • Number of events 1 • Adverse events data were collected for one year. Adverse events data were collected for one year, from the time of first patient enrollment to the last date of adverse event resolution.	0.00% 0/14 • Adverse events data were collected for one year. Adverse events data were collected for one year, from the time of first patient enrollment to the last date of adverse event resolution.

Other adverse events

Measure	Plant Seed Oil n=28 participants at risk Borage/Echium plant seed oils: 6.0 g/day borage seed oil and 6.0 g/day echium seed oil) (containing totals of \~ 1.7 g/day of GLA and 0.7 g/day of SDA)	Placebo n=28 participants at risk Placebo (11 g of corn oil/day)	Washout After Plant Seed Oil n=14 participants at risk Washout period between first (plant seed oil) and second (placebo) treatment assignments	Washout After Placebo n=14 participants at risk Washout period between first (placebo) and second (plant seed oil) treatment assignments
Blood and lymphatic system disorders Drop in Hemoglobin	0.00% 0/28 • Adverse events data were collected for one year. Adverse events data were collected for one year, from the time of first patient enrollment to the last date of adverse event resolution.	0.00% 0/28 • Adverse events data were collected for one year. Adverse events data were collected for one year, from the time of first patient enrollment to the last date of adverse event resolution.	7.1% 1/14 • Number of events 1 • Adverse events data were collected for one year. Adverse events data were collected for one year, from the time of first patient enrollment to the last date of adverse event resolution.	0.00% 0/14 • Adverse events data were collected for one year. Adverse events data were collected for one year, from the time of first patient enrollment to the last date of adverse event resolution.
Blood and lymphatic system disorders drop in hematocrit	3.6% 1/28 • Number of events 1 • Adverse events data were collected for one year. Adverse events data were collected for one year, from the time of first patient enrollment to the last date of adverse event resolution.	0.00% 0/28 • Adverse events data were collected for one year. Adverse events data were collected for one year, from the time of first patient enrollment to the last date of adverse event resolution.	0.00% 0/14 • Adverse events data were collected for one year. Adverse events data were collected for one year, from the time of first patient enrollment to the last date of adverse event resolution.	0.00% 0/14 • Adverse events data were collected for one year. Adverse events data were collected for one year, from the time of first patient enrollment to the last date of adverse event resolution.
Gastrointestinal disorders stomach ache	0.00% 0/28 • Adverse events data were collected for one year. Adverse events data were collected for one year, from the time of first patient enrollment to the last date of adverse event resolution.	7.1% 2/28 • Number of events 2 • Adverse events data were collected for one year. Adverse events data were collected for one year, from the time of first patient enrollment to the last date of adverse event resolution.	0.00% 0/14 • Adverse events data were collected for one year. Adverse events data were collected for one year, from the time of first patient enrollment to the last date of adverse event resolution.	0.00% 0/14 • Adverse events data were collected for one year. Adverse events data were collected for one year, from the time of first patient enrollment to the last date of adverse event resolution.
Gastrointestinal disorders food poisoning	0.00% 0/28 • Adverse events data were collected for one year. Adverse events data were collected for one year, from the time of first patient enrollment to the last date of adverse event resolution.	3.6% 1/28 • Number of events 1 • Adverse events data were collected for one year. Adverse events data were collected for one year, from the time of first patient enrollment to the last date of adverse event resolution.	0.00% 0/14 • Adverse events data were collected for one year. Adverse events data were collected for one year, from the time of first patient enrollment to the last date of adverse event resolution.	0.00% 0/14 • Adverse events data were collected for one year. Adverse events data were collected for one year, from the time of first patient enrollment to the last date of adverse event resolution.
Immune system disorders urticaria	0.00% 0/28 • Adverse events data were collected for one year. Adverse events data were collected for one year, from the time of first patient enrollment to the last date of adverse event resolution.	0.00% 0/28 • Adverse events data were collected for one year. Adverse events data were collected for one year, from the time of first patient enrollment to the last date of adverse event resolution.	0.00% 0/14 • Adverse events data were collected for one year. Adverse events data were collected for one year, from the time of first patient enrollment to the last date of adverse event resolution.	7.1% 1/14 • Number of events 1 • Adverse events data were collected for one year. Adverse events data were collected for one year, from the time of first patient enrollment to the last date of adverse event resolution.
General disorders fatigue	0.00% 0/28 • Adverse events data were collected for one year. Adverse events data were collected for one year, from the time of first patient enrollment to the last date of adverse event resolution.	3.6% 1/28 • Number of events 1 • Adverse events data were collected for one year. Adverse events data were collected for one year, from the time of first patient enrollment to the last date of adverse event resolution.	0.00% 0/14 • Adverse events data were collected for one year. Adverse events data were collected for one year, from the time of first patient enrollment to the last date of adverse event resolution.	0.00% 0/14 • Adverse events data were collected for one year. Adverse events data were collected for one year, from the time of first patient enrollment to the last date of adverse event resolution.
Immune system disorders allergies	0.00% 0/28 • Adverse events data were collected for one year. Adverse events data were collected for one year, from the time of first patient enrollment to the last date of adverse event resolution.	3.6% 1/28 • Number of events 1 • Adverse events data were collected for one year. Adverse events data were collected for one year, from the time of first patient enrollment to the last date of adverse event resolution.	0.00% 0/14 • Adverse events data were collected for one year. Adverse events data were collected for one year, from the time of first patient enrollment to the last date of adverse event resolution.	0.00% 0/14 • Adverse events data were collected for one year. Adverse events data were collected for one year, from the time of first patient enrollment to the last date of adverse event resolution.
Infections and infestations candidiasis	0.00% 0/28 • Adverse events data were collected for one year. Adverse events data were collected for one year, from the time of first patient enrollment to the last date of adverse event resolution.	0.00% 0/28 • Adverse events data were collected for one year. Adverse events data were collected for one year, from the time of first patient enrollment to the last date of adverse event resolution.	0.00% 0/14 • Adverse events data were collected for one year. Adverse events data were collected for one year, from the time of first patient enrollment to the last date of adverse event resolution.	7.1% 1/14 • Number of events 1 • Adverse events data were collected for one year. Adverse events data were collected for one year, from the time of first patient enrollment to the last date of adverse event resolution.
Reproductive system and breast disorders uterine fibroid	3.6% 1/28 • Number of events 1 • Adverse events data were collected for one year. Adverse events data were collected for one year, from the time of first patient enrollment to the last date of adverse event resolution.	0.00% 0/28 • Adverse events data were collected for one year. Adverse events data were collected for one year, from the time of first patient enrollment to the last date of adverse event resolution.	0.00% 0/14 • Adverse events data were collected for one year. Adverse events data were collected for one year, from the time of first patient enrollment to the last date of adverse event resolution.	0.00% 0/14 • Adverse events data were collected for one year. Adverse events data were collected for one year, from the time of first patient enrollment to the last date of adverse event resolution.
Respiratory, thoracic and mediastinal disorders Upper Respiratory Infection	32.1% 9/28 • Number of events 10 • Adverse events data were collected for one year. Adverse events data were collected for one year, from the time of first patient enrollment to the last date of adverse event resolution.	25.0% 7/28 • Number of events 7 • Adverse events data were collected for one year. Adverse events data were collected for one year, from the time of first patient enrollment to the last date of adverse event resolution.	28.6% 4/14 • Number of events 5 • Adverse events data were collected for one year. Adverse events data were collected for one year, from the time of first patient enrollment to the last date of adverse event resolution.	14.3% 2/14 • Number of events 2 • Adverse events data were collected for one year. Adverse events data were collected for one year, from the time of first patient enrollment to the last date of adverse event resolution.
Respiratory, thoracic and mediastinal disorders cough, chest tightness	10.7% 3/28 • Number of events 3 • Adverse events data were collected for one year. Adverse events data were collected for one year, from the time of first patient enrollment to the last date of adverse event resolution.	0.00% 0/28 • Adverse events data were collected for one year. Adverse events data were collected for one year, from the time of first patient enrollment to the last date of adverse event resolution.	0.00% 0/14 • Adverse events data were collected for one year. Adverse events data were collected for one year, from the time of first patient enrollment to the last date of adverse event resolution.	7.1% 1/14 • Number of events 1 • Adverse events data were collected for one year. Adverse events data were collected for one year, from the time of first patient enrollment to the last date of adverse event resolution.
Respiratory, thoracic and mediastinal disorders worsening asthma symptoms	0.00% 0/28 • Adverse events data were collected for one year. Adverse events data were collected for one year, from the time of first patient enrollment to the last date of adverse event resolution.	3.6% 1/28 • Number of events 1 • Adverse events data were collected for one year. Adverse events data were collected for one year, from the time of first patient enrollment to the last date of adverse event resolution.	7.1% 1/14 • Number of events 1 • Adverse events data were collected for one year. Adverse events data were collected for one year, from the time of first patient enrollment to the last date of adverse event resolution.	0.00% 0/14 • Adverse events data were collected for one year. Adverse events data were collected for one year, from the time of first patient enrollment to the last date of adverse event resolution.
Respiratory, thoracic and mediastinal disorders bronchitis	0.00% 0/28 • Adverse events data were collected for one year. Adverse events data were collected for one year, from the time of first patient enrollment to the last date of adverse event resolution.	0.00% 0/28 • Adverse events data were collected for one year. Adverse events data were collected for one year, from the time of first patient enrollment to the last date of adverse event resolution.	0.00% 0/14 • Adverse events data were collected for one year. Adverse events data were collected for one year, from the time of first patient enrollment to the last date of adverse event resolution.	7.1% 1/14 • Number of events 1 • Adverse events data were collected for one year. Adverse events data were collected for one year, from the time of first patient enrollment to the last date of adverse event resolution.
Respiratory, thoracic and mediastinal disorders sore throat	0.00% 0/28 • Adverse events data were collected for one year. Adverse events data were collected for one year, from the time of first patient enrollment to the last date of adverse event resolution.	7.1% 2/28 • Number of events 2 • Adverse events data were collected for one year. Adverse events data were collected for one year, from the time of first patient enrollment to the last date of adverse event resolution.	14.3% 2/14 • Number of events 2 • Adverse events data were collected for one year. Adverse events data were collected for one year, from the time of first patient enrollment to the last date of adverse event resolution.	0.00% 0/14 • Adverse events data were collected for one year. Adverse events data were collected for one year, from the time of first patient enrollment to the last date of adverse event resolution.
Skin and subcutaneous tissue disorders bruised rib	0.00% 0/28 • Adverse events data were collected for one year. Adverse events data were collected for one year, from the time of first patient enrollment to the last date of adverse event resolution.	3.6% 1/28 • Number of events 1 • Adverse events data were collected for one year. Adverse events data were collected for one year, from the time of first patient enrollment to the last date of adverse event resolution.	0.00% 0/14 • Adverse events data were collected for one year. Adverse events data were collected for one year, from the time of first patient enrollment to the last date of adverse event resolution.	0.00% 0/14 • Adverse events data were collected for one year. Adverse events data were collected for one year, from the time of first patient enrollment to the last date of adverse event resolution.

Additional Information

Elliot Israel, MD

Brigham and Women's Hospital

Phone: 617-732-2801

Email: eisrael@partners.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place