Clinical trial NCT02064738: 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
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2014-02-17
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Change in urinary leukotriene E4 levels
timeFrame: 2 weeks and 4 weeks
measure: Change in serum leukotriene B4 levels
timeFrame: 2 weeks and 4 weeks
Secondary outcomes:
measure: Change in asthma control questionnaire score
timeFrame: Baseline, 2 weeks, and 4 weeks
measure: Change in Sino-Nasal Outcome Test-22 (SNOT-22) score
timeFrame: Baseline, 2 weeks, and 4 weeks
measure: Change in forced expiratory volume in one second (FEV1), forced vital capacity (FVC), and FEV1/FVC
timeFrame: Baseline, two weeks, and four weeks
Other outcomes:
measure: Change in urinary prostaglandin D2 level
timeFrame: 2 weeks and 4 weeks
measure: Change in blood eosinophil count
timeFrame: 2 weeks and 4 weeks
measure: Change in platelet-leukocyte aggregates
timeFrame: 2 weeks and 4 weeks
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Tanya M Laidlaw, MD
role: PRINCIPAL_INVESTIGATOR
References: