Expired Study
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Bloomington, Indiana 47405


Purpose:

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


Study summary:

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.


Criteria:

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.


NCT ID:

NCT00676468


Primary Contact:

Study Director
Timothy D Mickleborough, PhD
Indiana University


Backup Contact:

N/A


Location Contact:

Bloomington, Indiana 47405
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 22, 2018

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