ASA Triad, Asthma, Nasal Polyps, And Aspirin Intolerance
Conditions
Keywords
Omega-3 fatty acids, Omega-6 fatty acids, aspirin exacerbated respiratory disease, AERD, Samter's Triad, nasal polyp, aspirin, diet, leukotriene
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).
Interventions
BEHAVIORALRestricting daily intake of omega-6 fatty acids to less than 4 grams and increasing omega-3 fatty acids to 3 grams
Sponsors
Brigham and Women's Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| 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 |
Other
| Measure | Time frame |
|---|---|
| Change in blood eosinophil count | 2 weeks and 4 weeks |
| Change in platelet-leukocyte aggregates | 2 weeks and 4 weeks |
| Change in urinary prostaglandin D2 level | 2 weeks and 4 weeks |
Countries
United States
Outcome results
None listed