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

Indiana University

Status and phase: Completed; Phase 1

Conditions: Asthma

Treatments: Other: Active Montelukast + Fish Oil Placebo; Other: Active Fish Oil + Montelukast Placebo; Other: Active Montelukast + Active Fish Oil

Study type: Interventional

Funder types: Other

Identifiers

NCT00676468

07-11765

Details and patient eligibility

About

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

Full description

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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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20 participants in 3 patient groups

1

Other group

Description:

Active Montelukast + Fish Oil Placebo

Treatment:

Other: Active Montelukast + Fish Oil Placebo

2

Other group

Description:

Active Fish Oil + Montelukast Placebo

Treatment:

Other: Active Fish Oil + Montelukast Placebo

3

Other group

Description:

Active Montelukast + Active Fish Oil

Treatment:

Other: Active Montelukast + Active Fish Oil