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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00676468
• Other study ID #: 07-11765
• Status: Completed
• Phase: Phase 1
• First received: May 9, 2008
• Last updated: October 8, 2009
• Start date: September 2008
• Est. completion date: April 2009

Study information

• Verified date: October 2009
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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 ß2-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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma
• Inflammation

Intervention

Other:
• 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
• 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.
• 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.

Locations

Country	Name	City	State
United States	Indiana University	Bloomington	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

References & Publications (2)

Mickleborough TD, Lindley MR, Ionescu AA, Fly AD. Protective effect of fish oil supplementation on exercise-induced bronchoconstriction in asthma. Chest. 2006 Jan;129(1):39-49. — View Citation

Mickleborough TD, Murray RL, Ionescu AA, Lindley MR. Fish oil supplementation reduces severity of exercise-induced bronchoconstriction in elite athletes. Am J Respir Crit Care Med. 2003 Nov 15;168(10):1181-9. Epub 2003 Aug 6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pulmonary function		6 weeks	No
Secondary	Exhaled breathe condensate markers to measure airway inflammation		6 weeks	No