Table 2.

Participant Selection

Criteria for Enrollment - Inclusion M ales or females between and including the ages 12 through 25 years. Participant must have physician-diagnosed persistent asthma (cannot have only exercise-induced or intermittent asthma). Lung Function Responsiveness Criteria (needs at least one of the following within the past 24 months): >12% β-agonist reversibility, using up to 4 puffs albuterol or levalbuterol or, PC20 FEV1 methacholine < 16 mg/ml or, Exercise bronchoprovacation test with a 20% or greater decrease in FEV1. FEV1 > 60% predicted pre-bronchodilator; Waist-circumference > 90th percentile based on age- and sex-based normative data. Participant must have a local asthma care provider to assist with clinical management. Evidence of Inadequate Recent Asthma Control: Participant must meet at least 1 of the following 4 criteria: Use of beta-agonist for asthma symptoms twice/week or more on average over the past month or, Nocturnal awakenings at least once per week on average due to asthma symptoms over the past month or, Two or more emergency room visits, unscheduled physician visits for asthma, prednisone courses, or hospitalizations for asthma in the past 12 months or, a Score of 1.25 or greater on the Juniper Scale of Asthma Control (ACS) at the screening visit. Participant must have been on some form of daily asthma controller therapy, can include ICS-LABA or LTRA. Patients on LTRA will proceed to step-down/conversion to inhaled corticosteroids for controller therapy (see Leukotriene Modifier (LM) Stepdown/ICS Converion Procedure). Participants must be adhering to daily therapy at least 5 or more days per week on average; For adults, asthma symptoms must have had onset during childhood (before age 18);

Criteria for Enrollment – Exclusion (participant cannot have any of the following): Currently taking nutritional oil supplements; Daily LTRA therapy currently or within last 8 weeks; Daily oral corticosteroid use; Hospitalization or urgent medical care visit for asthma within past 4 weeks; Allergy to fish or fish oil supplements or omega-3-acid ethyl esters or soy in the past; Febrile illness within past 24 hours (>38.0C) or upper respiratory infections within the past 2 weeks; Currently planning any changes in diet during the run-in or treatment period; Any smoking history within the past 2 years; Any patient with a history of prolonged bleeding time, coagulopathy, or severe clinical bleeding (prolonged nose bleeds or menorrhagia); Any patient currently taking daily therapeutic anti-coagulants or blood thinners (such as aspirin, warfarin, heparin or NSAIDS); For girls: Current pregnancy, or recent pregnancy and currently lactating; females enrolled must agree to practice an adequate birth control method (abstinence, combination, barrier/spermicide, OCP) for the duration of the study; Concurrent diseases that, in the investigator’s opinion, would interfere with participation in the study or might put the participant at risk by participating; Inability to give informed consent or comply with study procedures.