NCT05613803CompletedPhase 3
Poly-unsaturated Fats for Improving Nasal Polyps and Asthma
The Efficacy and Mechanisms of Action of n-3 Poly-unsaturated Fatty Acid Supplementation in People With Non-steroidal Exacerbated Airways Disease and Uncontrolled Asthma
Source: ClinicalTrials.gov · Last updated 8 Jun 2026
Brief summary (registry, in English)
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
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 18 (actual)
- First submitted
- 4 Nov 2022
- Start date
- 9 Oct 2023
- Primary completion date
- 31 Jan 2026
- Lead sponsor
- Norfolk and Norwich University Hospitals NHS Foundation Trust
- Diseases
- Asthma
- NCT number
- NCT05613803
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 18
- From 9 Oct 2023 to the primary completion date, 31 Jan 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- receiving aspirin desensitisation therapy or biologic agents
- receiving n-3 fatty acid oral supplements
Other illness
- significant cardiac disease, respiratory disease or other cause for breathlessness other than asthma
- severe or uncontrolled co-morbid disease (other than nasal polyps) which is likely to affect the outcome of the study
- having had an upper or lower respiratory tract infection requiring antibiotics within four weeks of randomisation
Other
- current smoker or more than 15 pack-year smoking history
- consumption of more than 21 units of alcohol per week as alcohol-induced respiratory symptoms are more common in N-ERD.
- patients unable to give written informed consent.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Norfolk and Norwich University Hospitals NHS Foundation Trust Coordinator of this site? Confirm its status | Norwich | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.