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

Not Applicable

Completed

• Conditions: ASA Triad; Asthma, Nasal Polyps, And Aspirin Intolerance
• Interventions: Behavioral: Restricting daily intake of omega-6 fatty acids to less than 4 grams and increasing omega-3 fatty acids to 3 grams

• Registration Number: NCT02064738
• Lead Sponsor: Brigham and Women's Hospital

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-02-14
• Study First Submitted QC: 2014-02-14
• Study First Posted: 2014-02-17
• Study Start: 2014-03
• Primary Completion: 2017-03
• Study Completion: 2017-04
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-14
• Last Update Posted: 2019-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Low omega-6/high omega-3 diet	Restricting daily intake of omega-6 fatty acids to less than 4 grams and increasing omega-3 fatty acids to 3 grams	Restricting daily intake of omega-6 fatty acids to less than 4 grams and increasing omega-3 fatty acids to 3 grams

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Change in Sino-Nasal Outcome Test-22 (SNOT-22) score	Baseline, 2 weeks, and 4 weeks
Change in asthma control questionnaire 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

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States