High Omega-3/Low Omega-6 Treatment Diet for Aspirin-exacerbated Respiratory Disease (AERD)

Study Overview
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Brief Summary
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The purpose of this trial is to test the hypothesis that a treatment diet low in omega-6 fatty acids and high in omega-3 fatty acids can cause improvement in asthma symptoms, nasal symptoms, and pulmonary function in patients with aspirin-exacerbated respiratory disease (AERD).

Official Title
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A Pilot Study of the Effectiveness of a High Omega-3/Low Omega-6 Treatment Diet for Treating Aspirin-exacerbated Respiratory Disease

Conditions
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ASA Triad, Asthma, Nasal Polyps, And Aspirin Intolerance

Intervention / Treatment
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* Behavioral: Restricting daily intake of omega-6 fatty acids to less than 4 grams and increasing omega-3 fatty acids to 3 grams


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: History of physician-diagnosed asthma History of nasal polyposis History of at least two reactions to oral aspirin or other nonselective cyclooxygenase inhibitor with features of lower airway involvement (cough, chest tightness, wheezing, dyspnea), or diagnosis of AERD via a physician-conducted challenge to aspirin Age between 18 and 70 years Exclusion Criteria: Current smoking, defined as daily tobacco smoking in the last 6 months and at least one instance of tobacco smoking in the last 3 months. Current pregnancy or breastfeeding BMI <20 History of allergy to fish or any unwillingness to eat fish as a regular part of the diet Use of Zyflo (zileuton) in the last two weeks Presence of an implantable cardioverter-defibrillator Use of oral steroids in the last two weeks Participation in any other clinical trial in the last month Any use of nonsteroidal antiinflammatory drugs (NSAIDs) or any drug that inhibits the cyclooxygenase enzyme during the course of the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Normal diet<br>Two weeks of unaltered diet | |
| Experimental: Low omega-6/high omega-3 diet<br>Restricting daily intake of omega-6 fatty acids to less than 4 grams and increasing omega-3 fatty acids to 3 grams | Behavioral: Restricting daily intake of omega-6 fatty acids to less than 4 grams and increasing omega-3 fatty acids to 3 grams<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in urinary leukotriene E4 levels |  | 2 weeks and 4 weeks | 
| Change in serum leukotriene B4 levels |  | 2 weeks and 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in asthma control questionnaire score |  | Baseline, 2 weeks, and 4 weeks | 
| Change in Sino-Nasal Outcome Test-22 (SNOT-22) score |  | Baseline, 2 weeks, and 4 weeks | 
| Change in forced expiratory volume in one second (FEV1), forced vital capacity (FVC), and FEV1/FVC |  | Baseline, two weeks, and four weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Omega-3 fatty acids, Omega-6 fatty acids, aspirin exacerbated respiratory disease, AERD, Samter's Triad, nasal polyp, aspirin, diet, leukotriene