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

Primary Purpose

ASA Triad, Asthma, Nasal Polyps, And Aspirin Intolerance

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Restricting daily intake of omega-6 fatty acids to less than 4 grams and increasing omega-3 fatty acids to 3 grams
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ASA Triad focused on measuring Omega-3 fatty acids, Omega-6 fatty acids, aspirin exacerbated respiratory disease, AERD, Samter's Triad, nasal polyp, aspirin, diet, leukotriene

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Brigham and Women's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Normal diet

Low omega-6/high omega-3 diet

Arm Description

Two weeks of unaltered diet

Restricting daily intake of omega-6 fatty acids to less than 4 grams and increasing omega-3 fatty acids to 3 grams

Outcomes

Primary Outcome Measures

Change in urinary leukotriene E4 levels
Change in serum leukotriene B4 levels

Secondary Outcome Measures

Change in asthma control questionnaire score
Change in Sino-Nasal Outcome Test-22 (SNOT-22) score
Change in forced expiratory volume in one second (FEV1), forced vital capacity (FVC), and FEV1/FVC

Full Information

First Posted
February 14, 2014
Last Updated
January 14, 2019
Sponsor
Brigham and Women's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02064738
Brief Title
High Omega-3/Low Omega-6 Treatment Diet for Aspirin-exacerbated Respiratory Disease (AERD)
Official Title
A Pilot Study of the Effectiveness of a High Omega-3/Low Omega-6 Treatment Diet for Treating Aspirin-exacerbated Respiratory Disease
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
March 2014 (Actual)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
April 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ASA Triad, Asthma, Nasal Polyps, And Aspirin Intolerance
Keywords
Omega-3 fatty acids, Omega-6 fatty acids, aspirin exacerbated respiratory disease, AERD, Samter's Triad, nasal polyp, aspirin, diet, leukotriene

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Normal diet
Arm Type
No Intervention
Arm Description
Two weeks of unaltered diet
Arm Title
Low omega-6/high omega-3 diet
Arm Type
Experimental
Arm Description
Restricting daily intake of omega-6 fatty acids to less than 4 grams and increasing omega-3 fatty acids to 3 grams
Intervention Type
Behavioral
Intervention Name(s)
Restricting daily intake of omega-6 fatty acids to less than 4 grams and increasing omega-3 fatty acids to 3 grams
Primary Outcome Measure Information:
Title
Change in urinary leukotriene E4 levels
Time Frame
2 weeks and 4 weeks
Title
Change in serum leukotriene B4 levels
Time Frame
2 weeks and 4 weeks
Secondary Outcome Measure Information:
Title
Change in asthma control questionnaire score
Time Frame
Baseline, 2 weeks, and 4 weeks
Title
Change in Sino-Nasal Outcome Test-22 (SNOT-22) score
Time Frame
Baseline, 2 weeks, and 4 weeks
Title
Change in forced expiratory volume in one second (FEV1), forced vital capacity (FVC), and FEV1/FVC
Time Frame
Baseline, two weeks, and four weeks
Other Pre-specified Outcome Measures:
Title
Change in urinary prostaglandin D2 level
Time Frame
2 weeks and 4 weeks
Title
Change in blood eosinophil count
Time Frame
2 weeks and 4 weeks
Title
Change in platelet-leukocyte aggregates
Time Frame
2 weeks and 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tanya M Laidlaw, MD
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Links:
URL
http://aerd.partners.org
Description
Brigham and Women's Hospital AERD website

Learn more about this trial

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

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