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

May 9, 2008
October 8, 2009
September 2008
April 2009   (final data collection date for primary outcome measure)
Pulmonary function [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00676468 on ClinicalTrials.gov Archive Site
Exhaled breathe condensate markers to measure airway inflammation [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Comparative Effects of Fish Oil Supplementation and a Montelukast on EIB and Airway Inflammation in Asthma
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

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Asthma
  • 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).
  • 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).
  • 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).
  • 1
    Active Montelukast + Fish Oil Placebo
    Intervention: Other: Active Montelukast + Fish Oil Placebo
  • 2
    Active Fish Oil + Montelukast Placebo
    Intervention: Other: Active Fish Oil + Montelukast Placebo
  • 3
    Active Montelukast + Active Fish Oil
    Intervention: Other: Active Montelukast + Active Fish Oil

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
April 2009
April 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years to 40 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00676468
07-11765
No
Timothy D Mickleborough / Associate Professor, Indiana University
Indiana University
Not Provided
Study Director: Timothy D Mickleborough, PhD Indiana University
Indiana University
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP