Poly-unsaturated Fats for Improving Nasal Polyps and Asthma

NCT05613803 | Unknown Phase 3

• 1 other identifier: (173-12-20)
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• Change in Asthma Control Questionnaire (ACQ) 6

  Asthma control questionnaire (ACQ) mean score 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.

  24 weeks post-randomisation

Study Arms (2)

Fish oil

ACTIVE COMPARATOR

6g of Eicosapentaenoic acid (EPA) and Docosahexaenoic acid (DHA) in a 1.3:1 ratio; respectively, as six Omacor capsules, taken once daily, or in divided doses, with food.

Drug: Fish oil

Placebo

PLACEBO COMPARATOR

Matched capsules (six) containing palm olein IV 56 taken once daily, or in divided doses, with food.

Other: Placebo

Interventions

Fish oil DRUG

6g of EPA and DHA in a 1.3:1 ratio as six Omacor capsules manufactured by Provona Biocare (Olso Norway), or generic equivalent, taken once daily, or in divided doses, with food.

Also known as: Active arm

Fish oil

Placebo OTHER

Six capsules containing palm oil and soybean oil on an 8:2 ratio taken once daily, or in divided doses, with food.

Also known as: Control arm

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• receiving aspirin desensitisation therapy or biologic agents
• receiving n-3 fatty acid oral supplements
• 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.

Sponsors & Collaborators

• Norfolk and Norwich University Hospitals NHS Foundation Trust: lead
• University of East Anglia: collaborator

Study Sites (1)

Norfolk and Norwich University Hospitals NHS Foundation Trust

Norwich, Norfolk, NR4 7UY, United Kingdom

RECRUITING

MeSH Terms

Conditions

Asthma

Interventions

Fish Oils

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Oils; Lipids

Study Officials

• Andrew Wilson

  University of East Anglia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrew Wilson

CONTACT

01603 286286; A.M.Wilson@uea.ac.uk

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2022
• First Posted: November 14, 2022
• Study Start: October 9, 2023
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2024
• Last Updated: December 4, 2023

Record last verified: 2023-11

Locations

GB (1)