Asthma
Conditions
Keywords
Asthma, Inflammation, Airway, Fish Oil, Singulair
Brief summary
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
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.
Interventions
OTHERActive 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
OTHERActive 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.
OTHERActive 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.
Sponsors
Indiana University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pulmonary function | 6 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Exhaled breathe condensate markers to measure airway inflammation | 6 weeks |
Countries
United States
Outcome results
None listed