Comparative Effects of Fish Oil Supplementation and a Montelukast on EIB and Airway Inflammation in Asthma
Completed · Phase 1 · Has a placebo group
Conditions studied: Asthma
In brief
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
Key facts
- Study ID
- NCT00676468
- Run by
- Indiana University
- People needed
- 20
- Starts
- 2008-09-01
- Expected to finish
- 2009-04-01
- Last updated by the study team
- 2009-10-09
Who can join
Age: 18 and older, up to 40. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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.
Where it is running
- Indiana University — Bloomington, Indiana, United States
Full record on ClinicalTrials.gov
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