Comparative Effects of Fish Oil Supplementation and a Montelukast on EIB and Airway Inflammation in Asthma - Full Text View

Sponsor:	Indiana University
Information provided by:	Indiana University
ClinicalTrials.gov Identifier:	NCT00676468

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

Condition	Intervention	Phase
Asthma	Other: Active Montelukast + Fish Oil Placebo Other: Active Fish Oil + Montelukast Placebo Other: Active Montelukast + Active Fish Oil	Phase I

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Comparative Effects of Fish Oil Supplementation and a Leukotriene Receptor Antagonist on EIB and Airway Inflammation in Asthma

Resource links provided by NLM:

MedlinePlus related topics: Asthma Dietary Supplements

Drug Information available for: Montelukast sodium Montelukast Fish oil

U.S. FDA Resources

Further study details as provided by Indiana University:

Primary Outcome Measures:

Pulmonary function [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Exhaled breathe condensate markers to measure airway inflammation [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Enrollment:	20
Study Start Date:	September 2008
Study Completion Date:	April 2009
Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 Active Montelukast + Fish Oil Placebo	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
2 Active Fish Oil + Montelukast Placebo	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.
3 Active Montelukast + Active Fish Oil	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.

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

Ages Eligible for Study:	18 Years to 40 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00676468

Locations

United States, Indiana
Indiana University
Bloomington, Indiana, United States, 47405

Sponsors and Collaborators

Indiana University

Investigators

Study Director:

Timothy D Mickleborough, PhD

Indiana University

More Information

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.

Responsible Party:	Indiana University ( Timothy D Mickleborough / Associate Professor )
Study ID Numbers:	07-11765
Study First Received:	May 9, 2008
Last Updated:	October 8, 2009
ClinicalTrials.gov Identifier:	NCT00676468 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Indiana University:

Asthma
Inflammation
Airway
Fish Oil
Singulair

Additional relevant MeSH terms:

Respiratory System Agents
Bronchial Diseases
Immune System Diseases
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Asthmatic Agents
Asthma
Pharmacologic Actions
Inflammation

Leukotriene Antagonists
Montelukast
Lung Diseases, Obstructive
Hypersensitivity
Pathologic Processes
Respiratory Tract Diseases
Therapeutic Uses
Lung Diseases
Hypersensitivity, Immediate
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on February 04, 2010