A 21-day, diet controlled, outpatient, open label trial in 16 healthy subjects conducted at Wake Forest University School of Medicine. Fatty acid levels, leukotriene levels and safety/tolerability were assessed. The results demonstrated that the use of the active ingredients in Efficas Care decreased leukotriene production.
A 14-day, single-center, randomized, double-blind, placebo-controlled, parallel-group escalating-intake inpatient clinical trial in healthy adults conducted in a Phase I unit. Patient population included 30 non-smoking, healthy male and female subjects aged between 18 and 45 years and within 15% of ideal body weight. Five of the subjects had allergies. Fatty acid levels, leukotriene levels and safety/tolerability were assessed. The trial was designed to determine the optimal amount of fatty acids required to reduce leukotriene levels and to confirm safety and efficacy of the formulation.
A 28-day, single-center, randomized, double-blind, placebo-controlled, parallel-group prospective efficacy clinical trial in patients with mild to moderate asthma conducted at Wake Forest University School of Medicine. Patient population included 43 adult patients age 15 to 65 years old. All patients had a diagnosis of asthma for at least one year and controlled their symptoms with beta-agonists and/or theophylline only. They also had a positive result on the methacholine challenge test as indicated by a PC20 of <8mg/ml, and a FEV1 > 70% of the predicted value. No patient could have taken inhaled or systemic steroids for = 4 weeks before study enrollment. Fatty acid levels, leukotriene levels and safety/tolerability were assessed (Surette et al., 2003b). Preliminary assessment of quality of life impact was also made (Surette et al., manuscript in preparation). This study demonstrated that Efficas Care decreased leukotriene production in 75% of asthmatics.
A multi-center pediatric pharmacokinetics trial conducted to determine the optimal intake for pediatric populations. Population consisted of 23 children aged to 6 to 11 and 12 to 17 with asthma. Twenty-two of the subjects also had sinus involvement (rhinitis or hay fever) and four had skin symptoms (dermatitis or eczema).
A 28-day, two-center, randomized, double-blind, placebo-controlled, parallel-group prospective study was conducted in adult subjects with asthma, allergic rhinitis or allergic eczema. Population consisted of males and females aged 18 – 65 years. Fatty acid levels, leukotriene levels, quality of life and safety/tolerability were assessed.
A 28-day, nation-wide, open label test of the impact of medical food Efficas Care on Quality of Life in consumer populations with Asthma, Allergic Rhinitis and Eczema. Population consisted of 473 adults age 22 to 55 years old. The study objective was to evaluate the impact on quality of life by using self-administered QOL instruments. There were no dietary or medications restrictions during the test period. The study period encompassed the summer allergy season.