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

ASA Triad Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02064738
• Other study ID #: 2013-P002683
• Status: Completed
• Phase: N/A
• Start date: March 2014
• Est. completion date: April 2017

Study information

• Verified date: January 2019
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: April 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• ASA Triad
• Asthma, Aspirin-Induced
• Asthma, Nasal Polyps, And Aspirin Intolerance
• Nasal Polyps
• Respiration Disorders
• Respiratory Tract Diseases

Intervention

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

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in urinary prostaglandin D2 level		2 weeks and 4 weeks
Other	Change in blood eosinophil count		2 weeks and 4 weeks
Other	Change in platelet-leukocyte aggregates		2 weeks and 4 weeks
Primary	Change in urinary leukotriene E4 levels		2 weeks and 4 weeks
Primary	Change in serum leukotriene B4 levels		2 weeks and 4 weeks
Secondary	Change in asthma control questionnaire score		Baseline, 2 weeks, and 4 weeks
Secondary	Change in Sino-Nasal Outcome Test-22 (SNOT-22) score		Baseline, 2 weeks, and 4 weeks
Secondary	Change in forced expiratory volume in one second (FEV1), forced vital capacity (FVC), and FEV1/FVC		Baseline, two weeks, and four weeks

External Links

•   Brigham and Women's Hospital AERD website