Comparative Effects of Fish Oil Supplementation and a Montelukast on EIB and Airway Inflammation in Asthma

Indiana University20 enrolled

Overview

Combining fish oil supplementation and Montelukast \[a commonly used cyst LT1 receptor antagonist to treat exercise-induced bronchoconstriction (EIB)\] will provide a greater antiinflammatory effect against developing EIB that either agent alone

The aim of this study is to extend previous published findings that fish oil supplementation represents a beneficial treatment on exercise-induced bronchoconstriction (EIB). An important question is how dietary fish oil supplementation fits in with the available armamentarium \[e.g., leukotriene (LT) modifiers\] to decrease the expression of LTs, and whether fish oil supplementation may be additive, or used in its own right to block the EIB response. For example, it is possible that a combination of fish oil supplementation and a cyst LT1 receptor antagonist (LTRA) may provide a greater antiinflammatory effect against developing EIB that either agent alone.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Asthma

Interventions

Active Montelukast + Fish Oil PlaceboOTHER

Montelukast (1 x 10 mg tablet) per day + 10 tablets of fish oil placebo (soy bean oil) per day for a duration of 3 weeks

Active Fish Oil + Montelukast PlaceboOTHER

10 tablets (3.2 g EPA + 2.0 g DHA) per day and 1 x 10 mg Montelukast Placebo tablet per day for a duration of 3 weeks.

Active Montelukast + Active Fish OilOTHER

1 x 10 mg Montelukast tablet per day and 10 tablets of active fish oil (3.2 g EPA + 2.0 g DHA) for a duration of 3 weeks.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 40 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Demonstrate a fall in post-exercise FEV1 of \> 10% after dry air exercise challenge for the diagnosis of EIB and * \> 12% increase in FEV1 from the baseline value after the administration of a β2-agonist. However, if the bronchodilator response is \< 12% increase in FEV1 from the baseline value then asthmatic subjects with EIB must further demonstrate * A \< 16.0 mg.ml-1 concentration of methacholine causing a 20% decrease in FEV1 (PC20) Exclusion Criteria: * Subjects will be excluded if they are pregnant * Have a history of hyperlipidemia, hypertension, diabetes, bleeding disorders, delayed clotting time * Taking aspirin medication and have a resting FEV1 less than 65% predicted. * A complete blood count and urinary pregnancy tests will be conducted at the beginning of the study and subjects with a hematocrit \< 35 will be excluded from participation in the study. * In addition, subjects will also be excluded if they have a history of taking n-3 PUFA supplements or supplements with antioxidants above the levels recommended for Adequate Intake, or regularly consume more than one fish meal per week.

Locations (1)

Indiana University

Bloomington, Indiana, United States

Outcomes

Primary Outcomes

Pulmonary function

Time frame: 6 weeks

Secondary Outcomes

Exhaled breathe condensate markers to measure airway inflammation

Time frame: 6 weeks

Data from ClinicalTrials.gov

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