Comparative Effects of Fish Oil Supplementation and a Montelukast on EIB and Airway Inflammation in Asthma
Information source: Indiana University
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma
Intervention: Active Montelukast + Fish Oil Placebo (Other); Active Fish Oil + Montelukast Placebo (Other); Active Montelukast + Active Fish Oil (Other)
Phase: Phase 1
Status: Not yet recruiting
Sponsored by: Indiana University Official(s) and/or principal investigator(s):
Timothy D Mickleborough, PhD, Study Director, Affiliation: Indiana University
Overall contact:
Timothy D Mickleborough, PhD, Phone: 812-855-0753, Email: tmickleb@indiana.edu
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
Clinical Details
Official title: Comparative Effects of Fish Oil Supplementation and a Leukotriene Receptor Antagonist on EIB and Airway Inflammation in Asthma
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Pulmonary function
Secondary outcome: Exhaled breathe condensate markers to measure airway inflammation
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 40 Years.
Gender(s): Both.
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.
Locations and Contacts
Timothy D Mickleborough, PhD, Phone: 812-855-0753, Email: tmickleb@indiana.edu
Indiana University, Bloomington, Indiana 47405, United States
Additional Information
Related publications: Mickleborough TD, Murray RL, Ionescu AA, Lindley MR. Fish oil supplementation reduces severity of exercise-induced bronchoconstriction in elite athletes. Am J Respir Crit Care Med. 2003 Nov 15;168(10):1181-9. Epub 2003 Aug 6. Mickleborough TD, Lindley MR, Ionescu AA, Fly AD. Protective effect of fish oil supplementation on exercise-induced bronchoconstriction in asthma. Chest. 2006 Jan;129(1):39-49.
Starting date: June 2008
Ending date: December 2008
Last updated: May 12, 2008
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