Clinical study of the effects on asthma-related QOL and asthma management of a medical food in adult asthma patients.
BACKGROUND
Asthma can have a negative impact on quality of life although this is not well correlated with objective evaluations of pulmonary function. A medical food, EFF1009, containing the fatty acids gamma-linolenic acid (GLA) and eicosapentaenoic acid (EPA) decreases leukotriene B(4) synthesis in patients with asthma. Two previous clinical studies with EFF1009 provided preliminary evidence that the medical food improves asthma-related quality of life (ARQOL) and asthma management.


OBJECTIVE
To evaluate the impact on ARQOL of EFF1009 in adults with asthma.


METHODS
The study was a randomized, prospective, double-blind, placebo-controlled, parallel group study in twenty-one (N = 21 evaluable) subjects with mild to moderate persistent asthma who consumed the medical food emulsion or placebo emulsion daily for 28 days. All participants continued their asthma medications throughout the study. ARQOL, including asthma signs and symptoms, and asthma control were measured using the Mini Asthma Quality of Life Questionnaire (MiniAQLQ) and the Asthma Control Questionnaire (ACQ), administered at baseline, Day 14 and Day 28. Safety and tolerability parameters, including adverse events, were monitored.


RESULTS
Baseline ARQOL scores, forced expiratory volume in one second (FEV(1)) and other characteristics were balanced between both groups. Mean (standard error) total MiniAQLQ scores changed by 0.73 (0.38) and -0.22 (0.36) in the EFF1009 and placebo groups, respectively, (p < 0.05). The MiniAQLQ symptom domain score was improved in the EFF1009 group (p < 0.05). Total scores for the ACQ were not significantly improved in either group. Levels of the fatty acid EPA in plasma increased in the EFF1009 group but not the placebo group (p < 0.03). The medical food was well tolerated and no safety concerns were identified.


CONCLUSIONS
The dietary addition of the medical food EFF1009 to asthma management regimens can improve patient perceived, ARQOL and can also improve asthma management as evidenced by reduced asthma symptoms. An additional study of the medical food, with larger subject population and longer treatment duration, is warranted to confirm these findings.
Lindemann
Julianne
J
Efficas Inc., Boulder, CO, USA. jlindemann@efficas.com
David Pampe
E
E
Peterkin
Joanna J
JJ
Orozco-Cronin
Patti
P
Belofsky
Gil
G
Stull
Dean
D
D000328:Adult; D001249:Asthma / Q000178:diet therapy* / Q000503:physiopathology / Q000523:psychology*; D004311:Double-Blind Method; D015118:Eicosapentaenoic Acid / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D004655:Emulsions / Q000009:adverse effects / Q000627:therapeutic use; D005260:Female; D005527:Food, Fortified / Q000009:adverse effects; D006801:Humans; D007975:Leukotriene B4 / Q000008:administration & dosage / Q000009:adverse effects; D008297:Male; D010919:Placebos; D010938:Plant Oils / Q000008:administration & dosage / Q000009:adverse effects; D011788:Quality of Life; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D055815:Young Adult; D017965:gamma-Linolenic Acid / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use
C547171:EFF1009; D004655:Emulsions; D010919:Placebos; D010938:Plant Oils; D007975:Leukotriene B4; D017965:gamma-Linolenic Acid; D015118:Eicosapentaenoic Acid; C079363:borage oil