Scientific Title:

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

Chief Investigator:

Professor Andrew Wilson

Funder:

National Institute for Health Research Efficacy and Mechanism Evaluation (EME)

Sponsor:

Norfolk and Norwich University Hospitals NHS Foundation Trust

Health Condition or Problem Studied:

Non-steroidal exacerbated airways disease

Intervention:

Patients will be randomised on a 1:1 basis to receive either of the following for 24 weeks:

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

or

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

Study Design:

This study is an interventional clinical trial of an investigational medicinal product: a phase III, randomised, placebo-controlled, two arm parallel group, double-blind, multicentre clinical trial. Randomisation will be generated by a secure web-based system on a 1:1 basis with stratification for recruiting site and inclusion into sputum subgroup.

Target Sample Size:

98 participants (49 per group). 52 (26 per group) of whom will be recruited into the sputum sub-study.

Status:

In set-up