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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2009-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Comparison of Combination Therapy: Montelukast and Inhaled Steroid on Exercise Induced Bronchoconstriction

NCT00462592

Asthma

COMPLETED PHASE3

Two Investigational Drugs in the Prevention of Airway Constriction Brought on by Exercise in Participants With Asthma (0476-911)

NCT00127166

Exercise Induced Asthma

COMPLETED PHASE3

Exercise Induced Bronchospasm in Children

NCT00273689

Exercise Induced Bronchospasm

COMPLETED PHASE4

Exercise Induced Bronchoconstriction (0476-359)

NCT00664937

Asthma, Exercise-induced

COMPLETED PHASE1

Montelukast Compared With Placebo and Salmeterol in Exercise-Induced Bronchoconstriction (0476-316)

NCT00245570

Asthma, Exercise-Induced

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Asthma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Active Montelukast + Fish Oil Placebo

Group Type OTHER

Active Montelukast + Fish Oil Placebo

Intervention Type 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

2

Active Fish Oil + Montelukast Placebo

Group Type OTHER

Active Fish Oil + Montelukast Placebo

Intervention Type 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.

3

Active Montelukast + Active Fish Oil

Group Type OTHER

Active Montelukast + Active Fish Oil

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type 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.

Intervention Type 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.

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

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

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No