Poly-unsaturated Fats for Improving Nasal Polyps and Asthma (NCT05613803) | Clinical Trial Compass
CompletedPhase 3
Poly-unsaturated Fats for Improving Nasal Polyps and Asthma
United Kingdom18 participantsStarted 2023-10-09
Plain-language summary
Asthma is a syndrome compromising many phenotypes including N-ERD (caused by increased 4-series leukotriene (LT) production). n-3 PUFA supplementation modulates 4-series LT and has anti-inflammatory effects. However, other than in a pilot study with dietary manipulation, the effects of N-ERD are unknown. The primary objective is to determine whether n-3 PUFA supplementation in people with N-ERD can improve asthma control using the asthma control questionnaire (ACQ-7). This is a placebo controlled randomised controlled parallel multicentre study with of 6g per day of PUFA for 6 months in people with N-ERD and poor asthma control
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. aged ≥18 years. N-ERD does not occur at birth and it rarely occurs in children.
. physician labelled diagnosis of asthma.
. history of N-ERD according EAACI guidelines(9) with evidence of one of 1) Clinical diagnosis as evidence by i. A reliable history of aspirin or NSAID induced respiratory reaction as evidenced by more than one reaction, reactions to two or more different NSAIDs or the last reaction occurring within the last 5 years plus ii. Recurrent nasal polyposis, anosmia, moderate to severe asthma, intolerance to alcohol and/or blood eosinophilia 2) Positive nasal or bronchial aspirin challenge(43)
. ACQ of more than 1.5 as this indicates poor control. This is required to ensure there is a clinical need or a requirement to alter medication.
. stable disease, as evidenced by a lack of change in asthma therapy within the last 6 weeks.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial tested poly-unsaturated fats as a way to improve asthma control, measured by the ACQ-6 questionnaire — do you think dietary fat changes like this could realistically help my specific type of asthma, and is the evidence from this completed Phase 3 trial strong enough to act on?
2Since this is a completed Phase 3 trial, would you be able to look up the published results and tell me whether the poly-unsaturated fat intervention actually showed meaningful improvement in asthma control scores compared to a control group?
3This study also looked at nasal polyps alongside asthma — do I have any signs of nasal polyps, and if so, does that change whether an approach like this might be worth discussing for my situation?
4Poly-unsaturated fats are something people can adjust through diet or supplements — before considering anything like this, are there standard asthma treatments I haven't tried yet that should come first?
5If the results of this trial do look promising, what would actually be involved in changing my intake of poly-unsaturated fats, and are there any risks or interactions with my current medications I should know about?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Asthma Control Questionnaire (ACQ) 6
Timeframe: 24 weeks post-randomisation
Trial details
NCT IDNCT05613803
SponsorNorfolk and Norwich University Hospitals NHS Foundation Trust