Back to Search
Start Over
Clinical study of the effects on asthma-related QOL and asthma management of a medical food in adult asthma patients.
- Source :
-
Current medical research and opinion [Curr Med Res Opin] 2009 Dec; Vol. 25 (12), pp. 2865-75. - Publication Year :
- 2009
-
Abstract
- 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.<br />Objective: To evaluate the impact on ARQOL of EFF1009 in adults with asthma.<br />Research Design and 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.<br />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.<br />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.
- Subjects :
- Adult
Asthma physiopathology
Double-Blind Method
Eicosapentaenoic Acid administration & dosage
Eicosapentaenoic Acid adverse effects
Eicosapentaenoic Acid therapeutic use
Emulsions adverse effects
Emulsions therapeutic use
Female
Humans
Leukotriene B4 administration & dosage
Leukotriene B4 adverse effects
Male
Placebos
Plant Oils administration & dosage
Plant Oils adverse effects
Surveys and Questionnaires
Treatment Outcome
Young Adult
gamma-Linolenic Acid administration & dosage
gamma-Linolenic Acid adverse effects
gamma-Linolenic Acid therapeutic use
Asthma diet therapy
Asthma psychology
Food, Fortified adverse effects
Quality of Life
Subjects
Details
- Language :
- English
- ISSN :
- 1473-4877
- Volume :
- 25
- Issue :
- 12
- Database :
- MEDLINE
- Journal :
- Current medical research and opinion
- Publication Type :
- Academic Journal
- Accession number :
- 19811112
- Full Text :
- https://doi.org/10.1185/03007990903316491