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

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 Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: December 2008

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.

Intervention(s) in this Clinical Trial

• Other: Active Montelukast + Fish Oil Placebo
  • 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
• Other: Active Fish Oil + Montelukast Placebo
  • 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.
• Other: Active Montelukast + Active Fish Oil
  • 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.

Arms, Groups and Cohorts in this Clinical Trial

• Other: 1
  • Active Montelukast + Fish Oil Placebo
• Other: 2
  • Active Fish Oil + Montelukast Placebo
• Other: 3
  • Active Montelukast + Active Fish Oil

Primary Measures

• Pulmonary function
  • Time Frame: 6 weeks
    Safety Issue?: No

Secondary Measures

• Exhaled breathe condensate markers to measure airway inflammation
  • Time Frame: 6 weeks
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 40 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Indiana University

Overall Clinical Trial Officials and Contacts

Timothy D Mickleborough, PhD Study Director Indiana University  

Overall Contact: Timothy D Mickleborough, PhD 812-855-0753 tmickleb@indiana.edu

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00676468

Study ID Number: 07-11765

ClinicalTrials.gov Identifier: NCT00676468

Health Authority: United States: Institutional Review Board