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

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Comparative Effects of Fish Oil Supplementation and a Leukotriene Receptor Antagonist on EIB and Airway Inflammation in Asthma

Conditions
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Asthma

Intervention / Treatment
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* Other: Active Montelukast + Fish Oil Placebo
* Other: Active Fish Oil + Montelukast Placebo
* Other: Active Montelukast + Active Fish Oil


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br>Active Montelukast + Fish Oil Placebo | Other: Active Montelukast + Fish Oil Placebo<br>* 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<br>* Other names: Singulair (montelukast). Placebo (no brand name).;|
| Other: 2<br>Active Fish Oil + Montelukast Placebo | Other: Active Fish Oil + Montelukast Placebo<br>* 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.<br>* Other names: Pro-Omega Fish Oil. Montelukast placebo (no brand name).;|
| Other: 3<br>Active Montelukast + Active Fish Oil | Other: Active Montelukast + Active Fish Oil<br>* 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.<br>* Other names: Singulair (Montelukast) and Pro-Omega (Fish Oil).;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulmonary function |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exhaled breathe condensate markers to measure airway inflammation |  | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asthma, Inflammation, Airway, Fish Oil, Singulair