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

This study has been completed.
Sponsor:
Information provided by:
Indiana University
ClinicalTrials.gov Identifier:
NCT00676468
First received: May 9, 2008
Last updated: October 8, 2009
Last verified: October 2009
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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:


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
Other Name: Singulair (montelukast). Placebo (no brand name).
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.
Other Name: Pro-Omega Fish Oil. Montelukast placebo (no brand name).
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.
Other Name: Singulair (Montelukast) and Pro-Omega (Fish Oil).

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

Keywords provided by Indiana University:
Asthma
Inflammation
Airway
Fish Oil
Singulair

Additional relevant MeSH terms:
Asthma
Inflammation
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Pathologic Processes
Montelukast
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 20, 2014