Clinical study of the effects on asthma-related QOL and asthma management of a medical food in adult asthma patients

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 B₄ 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.

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.

Results:

Baseline ARQOL scores, forced expiratory volume in one second (FEV₁) 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.

Key words::

• Asthma
• Dietary fatty acids
• Leukotriene
• Medical food
• Quality of life

Transparency

Declaration of funding

This work was funded by Efficas Inc., Boulder, CO, USA.

Declaration of financial/other relationships

J.L. has disclosed that she is employed by, and holds stock in, Efficas. D.S., G.B. and P.O.-C. have disclosed that they are former employees of Efficas. D.S. also has disclosed that he is a scientific consultant for, and holds stock in Efficas. E.D.P. has disclosed that he has no financial relationship with manufacturers that have an interest in the subject matter or materials discussed in the manuscript. J.J.P. has disclosed that she has been a medical consultant to Efficas. P.O.-C. and G.B. have also disclosed that they are Efficas stockholders.

Some peer reviewers receive honoraria from CMRO for their review work. The peer reviewers of this paper have disclosed that they have no relevant financial relationships.

Acknowledgment

The authors thank Tyson Lee, Statistical Consultant, Palo Alto, CA, USA, for his contribution to the experimental design and statistical treatment of the data; Nikki Christensen, Clinical Research Consultant, for project management; Letitia Thrash and Mary O’Connell of MetaClin for study conduct; Gigi Villanueva and Shannon Townsend of Efficas for study monitoring; and Melissa Brenkert, Consultant, for study auditing. The authors also thank Maurice Gaubatz, President and CEO, and Dave Robaugh, Director, Scientific Affairs of Pyxant Labs, Colorado Springs, CO, USA for fatty acid and plasma leukotriene method development and assays; and Karen Haschke and Dan Heir of Esoterix Inc. (A LabCorp Company) for clinical laboratory assays. Eric Schwab, Manager, Assay Services, Cayman Chemical Company, provided LTE₄ assay results. Special thanks to Rob Driver, Vice President, Operations, Efficas, for product manufacture, testing and helpful information.