Using fish oil to improve asthma control in patients with nasal polyps

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

This study is testing if taking fish oil can help adults with asthma and nasal polyps breathe better and feel healthier.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 98 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Norfolk and Norwich University Hospitals NHS Foundation Trust (Academic / other)
• Locations: 1 site (Norwich, Norfolk)
• Trial ID: NCT05613803 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effects of n-3 polyunsaturated fatty acid (PUFA) supplementation on asthma control in adults with non-steroidal anti-inflammatory drug-exacerbated respiratory disease (N-ERD). Participants will receive either 6g of n-3 PUFA or a placebo daily for six months, with asthma control assessed using the asthma control questionnaire (ACQ-7). The study aims to evaluate improvements in asthma symptoms, quality of life, and airway inflammation, while also examining the underlying mechanisms of action. It is a multicenter, randomized, placebo-controlled trial designed to provide robust evidence on the efficacy of n-3 PUFA in this specific patient population.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a physician-diagnosed asthma and a history of N-ERD.

Not a fit: Patients with significant cardiac or respiratory diseases, recent respiratory infections, or those receiving other asthma therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new dietary intervention to improve asthma control and quality of life for patients with N-ERD.

How similar studies have performed: While there have been pilot studies on dietary manipulation, this specific approach using n-3 PUFA for N-ERD is novel and has not been extensively tested in larger trials.

Eligibility criteria

Inclusion Criteria:

1. aged ≥18 years. N-ERD does not occur at birth and it rarely occurs in children.
2. physician labelled diagnosis of asthma.
3. 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)
4. 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.
5. stable disease, as evidenced by a lack of change in asthma therapy within the last 6 weeks.

Exclusion Criteria:

1. significant cardiac disease, respiratory disease or other cause for breathlessness other than asthma
2. severe or uncontrolled co-morbid disease (other than nasal polyps) which is likely to affect the outcome of the study
3. having had an upper or lower respiratory tract infection requiring antibiotics within four weeks of randomisation
4. receiving aspirin desensitisation therapy or biologic agents
5. receiving n-3 fatty acid oral supplements
6. current smoker or more than 15 pack-year smoking history
7. consumption of more than 21 units of alcohol per week as alcohol-induced respiratory symptoms are more common in N-ERD.
8. patients unable to give written informed consent.

Where this trial is running

Norwich, Norfolk

• Norfolk and Norwich University Hospitals NHS Foundation Trust — Norwich, Norfolk, United Kingdom (Recruiting)

Study contacts

• Principal investigator: Andrew Wilson — University of East Anglia
• Study coordinator: Andrew Wilson

Conditions Asthma