ASA TriadNCT02064738
High Omega-3/Low Omega-6 Treatment Diet for Aspirin-exacerbated Respiratory Disease (AERD)
A study testing Restricting daily intake of omega-6 fatty acids to less than 4 grams and increasing omega-3 fatty acids to 3 grams in people with ASA Triad and Asthma, Nasal Polyps, And Aspirin Intolerance, run by Brigham and Women's Hospital at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- ASA Triad, Asthma, Nasal Polyps, And Aspirin Intolerance
- What is being tested?
- Restricting daily intake of omega-6 fatty acids to less than 4 grams and increasing omega-3 fatty acids to 3 grams
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: A Pilot Study of the Effectiveness of a High Omega-3/Low Omega-6 Treatment Diet for Treating Aspirin-exacerbated Respiratory Disease
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).
- Being tested
- Restricting daily intake of omega-6 fatty acids to less than 4 grams and increasing omega-3 fatty acids to 3 grams
- Keywords
- Omega-3 fatty acids, Omega-6 fatty acids, aspirin exacerbated respiratory disease, AERD, Samter's Triad, nasal polyp, aspirin, diet, leukotriene
- Medical subject headings
- Asthma, Nasal Polyps, And Aspirin Intolerance, Nasal Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Restricting daily intake of omega-6 fatty acids to less than 4 grams and increasing omega-3 fatty acids to 3 gramsBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Restricting daily intake of omega-6 fatty acids to less than 4 grams and increasing omega-3 fatty acids to 3 grams |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in urinary leukotriene E4 levels
Measured: 2 weeks and 4 weeks
Change in serum leukotriene B4 levels
Measured: 2 weeks and 4 weeks
Secondary outcomes (3)
Change in asthma control questionnaire score
Measured: Baseline, 2 weeks, and 4 weeks
Change in Sino-Nasal Outcome Test-22 (SNOT-22) score
Measured: Baseline, 2 weeks, and 4 weeks
Change in forced expiratory volume in one second (FEV1), forced vital capacity (FVC), and FEV1/FVC
Measured: Baseline, two weeks, and four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2014 (estimated)
- Study startMar 2014
- Primary completionMar 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ASA TriadStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tanya Laidlaw, MD, Brigham and Women's Hospital
- Investigators
- Tanya M Laidlaw, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02064738
- Sponsor's protocol ID
- 2013-P002683
- Status last verified
- Jan 2019
- First submitted
- 14 Feb 2014
- Last updated
- 16 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of the Effectiveness of a High Omega-3/Low Omega-6 Treatment Diet for Treating Aspirin-exacerbated Respiratory Disease
- ClinicalTrials.gov ID
- NCT02064738
- Acronym / sponsor ID
- 2013-P002683
- Keywords
- Omega-3 fatty acids, Omega-6 fatty acids, aspirin exacerbated respiratory disease, AERD, Samter's Triad, nasal polyp, aspirin, diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- Mar 2014 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 17 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal diet | No intervention | –Two weeks of unaltered diet |
| Low omega-6/high omega-3 diet | Experimental | Behavioral: Restricting daily intake of omega-6 fatty acids to less than 4 grams and increasing omega-3 fatty acids to 3 gramsRestricting daily intake of omega-6 fatty acids to less than 4 grams and increasing omega-3 fatty acids to 3 grams |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Restricting daily intake of omega-6 fatty acids to less than 4 grams and increasing omega-3 fatty acids to 3 grams | Behavioural | Low omega-6/high omega-3 diet |
Primary outcome
Change in urinary leukotriene E4 levels
Time frame: 2 weeks and 4 weeks
Change in serum leukotriene B4 levels
Time frame: 2 weeks and 4 weeks
3 secondary outcomes
Change in asthma control questionnaire score
Time frame: Baseline, 2 weeks, and 4 weeks
Change in Sino-Nasal Outcome Test-22 (SNOT-22) score
Time frame: Baseline, 2 weeks, and 4 weeks
Change in forced expiratory volume in one second (FEV1), forced vital capacity (FVC), and FEV1/FVC
Time frame: Baseline, two weeks, and four weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2019.
- Brigham and Women's Hospital AERD websiteLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tanya M Laidlaw, MD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Restricting daily intake of omega-6 fatty acids to less than 4 grams and increasing omega-3 fatty acids to 3 grams in people with ASA Triad and Asthma, Nasal Polyps, And Aspirin Intolerance, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in urinary leukotriene E4 levels (time frame: 2 weeks and 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2019.