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

Phase 1

Completed

• Conditions: Asthma
• Interventions: Other: Active Fish Oil + Montelukast Placebo; Other: Active Montelukast + Active Fish Oil; Other: Active Montelukast + Fish Oil Placebo

• Registration Number: NCT00676468
• Lead Sponsor: Indiana University

Brief Summary

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

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 Timeline

• Study First Submitted: 2008-05-09
• Study First Submitted QC: 2008-05-12
• Study First Posted: 2008-05-13
• Study Start: 2008-09
• Primary Completion: 2009-04
• Study Completion: 2009-04
• Status Verified: 2009-10
• Last Update Submitted: 2009-10-08
• Last Update Posted: 2009-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Active Fish Oil + Montelukast Placebo	Active Fish Oil + Montelukast Placebo
3	Active Montelukast + Active Fish Oil	Active Montelukast + Active Fish Oil
1	Active Montelukast + Fish Oil Placebo	Active Montelukast + Fish Oil Placebo

Primary Outcome Measures

Name	Time	Method
Pulmonary function	6 weeks

Secondary Outcome Measures

Name	Time	Method
Exhaled breathe condensate markers to measure airway inflammation	6 weeks

Trial Locations

Locations (1)

Indiana University; 🇺🇸 Bloomington, Indiana, United States