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Completed

NCT Number: NCT00676468

Comparative Effects of Fish Oil Supplementation and a Montelukast 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

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Indiana University

Bloomington, Indiana, 47405, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Active Montelukast + Fish Oil Placebo

Other

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 names: Singulair (montelukast). Placebo (no brand name).

Active Fish Oil + Montelukast Placebo

Other

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 names: Pro-Omega Fish Oil. Montelukast placebo (no brand name).

Active Montelukast + Active Fish Oil

Other

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 names: Singulair (Montelukast) and Pro-Omega (Fish Oil).

Primary outcomes

  1. Pulmonary function

    Time frame: 6 weeks

Secondary outcomes

  1. Exhaled breathe condensate markers to measure airway inflammation

    Time frame: 6 weeks

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Registry information

Official study title

Comparative Effects of Fish Oil Supplementation and a Leukotriene Receptor Antagonist on EIB and Airway Inflammation in Asthma

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
May 13, 2008
Registry last updated
Oct 9, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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