NCT02064738

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 14, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 17, 2014

Completed
12 days until next milestone

Study Start

First participant enrolled

March 1, 2014

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

January 16, 2019

Status Verified

January 1, 2019

Enrollment Period

3 years

First QC Date

February 14, 2014

Last Update Submit

January 14, 2019

Conditions

ASA TriadAsthma, Nasal Polyps, And Aspirin Intolerance

Keywords

Omega-3 fatty acidsOmega-6 fatty acidsaspirin exacerbated respiratory diseaseAERDSamter's Triadnasal polypaspirindietleukotriene

Outcome Measures

Primary Outcomes (2)

  • Change in urinary leukotriene E4 levels

    2 weeks and 4 weeks

  • Change in serum leukotriene B4 levels

    2 weeks and 4 weeks

Secondary Outcomes (3)

  • Change in asthma control questionnaire score

    Baseline, 2 weeks, and 4 weeks

  • Change in Sino-Nasal Outcome Test-22 (SNOT-22) 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 Outcomes (3)

  • Change in urinary prostaglandin D2 level

    2 weeks and 4 weeks

  • Change in blood eosinophil count

    2 weeks and 4 weeks

  • Change in platelet-leukocyte aggregates

    2 weeks and 4 weeks

Study Arms (2)

Normal diet

NO INTERVENTION

Two weeks of unaltered diet

Low omega-6/high omega-3 diet

EXPERIMENTAL

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

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

Interventions

Restricting daily intake of omega-6 fatty acids to less than 4 grams and increasing omega-3 fatty acids to 3 gramsBEHAVIORAL
Low omega-6/high omega-3 diet

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Links

MeSH Terms

Conditions

Asthma, Nasal Polyps, And Aspirin IntoleranceNasal Polyps

Condition Hierarchy (Ancestors)

Nose DiseasesRespiratory Tract DiseasesOtorhinolaryngologic DiseasesPolypsPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Tanya M Laidlaw, MD

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Medicine, Harvard Medical School

Study Record Dates

First Submitted

February 14, 2014

First Posted

February 17, 2014

Study Start

March 1, 2014

Primary Completion

March 1, 2017

Study Completion

April 1, 2017

Last Updated

January 16, 2019

Record last verified: 2019-01

Locations

US(1)