A randomized, double-blind, placebo-controlled study to evaluate the effect of EFF1001, an Actinidia arguta (hardy kiwi) preparation, on CADESI score and pruritus in dogs with mild to moderate atopic dermatitis.

Canine atopic dermatitis (AD) is common and new therapies are beneficial. This multicentric, randomized, double-blind, placebo-controlled study tested the efficacy of Actinidia arguta (hardy kiwi) (EFF1001) in dogs with mild/moderate AD. The study was divided into two stages. Stage 1 lasted 6 weeks. In the first 2 weeks prednisolone [days 1-3: 0.2 mg/kg twice daily (BID), days 4-14: 0.2 mg/kg every other day (EOD)] was administered. Responsive dogs were placed on prednisolone 0.2 mg/kg EOD + assigned test article [either placebo or EFF1001 (30 mg/kg)] once daily for 4 weeks. Stage 1 responders were advanced to stage 2, which involved 4 weeks of just EFF1001. Clinicians scored lesions using Canine Atopic Dermatitis Extent and Severity Index (CADESI) and owners scored pruritus using a Pruritus Visual Analogue Scale. Seventy-seven dogs were enrolled, 76 were randomized on day 14, and 57 (57/76 = 75%) completed stage 1 (27 in EFF1001 and 30 in placebo). At the end of stage 1, 35 of 57 dogs (35/57 = 61%) responded (18 in EFF1001 and 17 in placebo) and advanced to stage 2. At completion of stage 1, CADESI scores did not significantly differ between groups while pruritus decreased in EFF1001 group and approached significance. At completion of stage 2, 19 dogs (19/35 = 54%) responded (15/19 = 79% had received EFF1001 and 4/19 = 21% placebo in stage 1). After completing stage 2, dogs placed on EFF1001 throughout the study were 3.5 times more likely to either maintain or improve scores than those that started it in stage 2. It is concluded that EFF1001 is beneficial adjunctive therapy after prolonged use.

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. 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 (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.

The impact of a medical food containing gammalinolenic and eicosapentaenoic acids on asthma management and the quality of life of adult asthma patients.

BACKGROUND: Leukotriene synthesis inhibitors and receptor antagonists are efficacious for the treatment of asthma. Diets containing the fatty acids gammalinolenic acid (GLA) and eicosapentaenoic acid (EPA) decrease leukotriene synthesis; however, their impact on asthma management and quality of life (QOL) has not been evaluated in asthmatic subjects. OBJECTIVE: To evaluate asthma management and the QOL of asthmatic adult subjects consuming a medical food emulsion containing GLA and EPA. RESEARCH DESIGN AND METHODS: Trial 1 was a randomized, prospective, double-blind, placebo-controlled, parallel group trial in atopic subjects with mild-to-moderate asthma (n = 35 evaluable) consuming a low dose (0.75 g GLA + 0.5 g EPA), high dose (1.13 g GLA + 0.75 g EPA) or placebo emulsion daily. Subjects were questioned about their asthma management using a non-validated questionnaire after 2 and 4 weeks. Blood leukotrienes were measured at baseline and after 4 weeks. Trial 2 was an open-label study (n = 65 evaluable) where subjects consumed the low-dose medical food emulsion, EFF1009, daily. QOL and asthma management were measured using the validated Mini Asthma Quality of Life (MiniAQLQ) and the Asthma Control (ACQ) questionnaires, respectively, administered at baseline and after 4 weeks. RESULTS: In Trial 1, leukotriene biosynthesis decreased (p < 0.05). Self-reported asthma status and bronchodilator use improved in subjects consuming low- and high-dose emulsion between week 2 and week 4 (p < 0.01), but not compared to placebo (p > 0.1). In Trial 2, mean +/- standard error total MiniAQLQ and ACQ scores improved by 1.5 +/- 0.2 and 1.0 +/- 0.1, respectively (p < 0.001). Subdomain scores from MiniAQLQ improved and rescue bronchodilator use decreased (p < 0.001). CONCLUSION: The inclusion of the medical food EFF1009 in asthma management regimens can improve patient quality of life and decrease reliance on rescue medication.