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Completed

NCT Number: NCT02064738

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

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).

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Key information

Conditions

ASA Triad Asthma, Nasal Polyps, And Aspirin Intolerance Nasal Polyps Nose Diseases Otorhinolaryngologic Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Polyps Respiratory Tract Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Behavioral

Primary outcomes

  1. Change in urinary leukotriene E4 levels

    Time frame: 2 weeks and 4 weeks

  2. Change in serum leukotriene B4 levels

    Time frame: 2 weeks and 4 weeks

Secondary outcomes

  1. Change in asthma control questionnaire score

    Time frame: Baseline, 2 weeks, and 4 weeks

  2. Change in Sino-Nasal Outcome Test-22 (SNOT-22) score

    Time frame: Baseline, 2 weeks, and 4 weeks

  3. 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 outcomes

  1. Change in urinary prostaglandin D2 level

    Time frame: 2 weeks and 4 weeks

  2. Change in blood eosinophil count

    Time frame: 2 weeks and 4 weeks

  3. Change in platelet-leukocyte aggregates

    Time frame: 2 weeks and 4 weeks

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Feb 17, 2014
Registry last updated
Jan 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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