Status:
COMPLETED
Comparative Effects of Fish Oil Supplementation and a Montelukast on EIB and Airway Inflammation in Asthma
Lead Sponsor:
Indiana University
Conditions:
Asthma
Eligibility:
All Genders
18-40 years
Phase:
PHASE1
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 a...
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 h...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00676468
Start Date
September 1 2008
End Date
April 1 2009
Last Update
October 9 2009
Active Locations (1)
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1
Indiana University
Bloomington, Indiana, United States, 47405