PURCON924 - PUFA IMP and Placebo

We are looking to contract with a manufacturer who can:

• Provide active Omacor capsules of n-3 PUFA (eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) in 1g capsules in a 1.3:1 ratio in accordance with specified regulations;
• Manufacture matched placebo (palm oil and soybean oil) soft-gel capsules in an 8:2 ratio in accordance with specified regulations;
• Bottle and label trial medication in accordance with specified regulations;
• QP release the active and placebo capsules with a minimum shelf life of 12 months; and
• Either, ship final trial medication direct to participants following dispensing centrally OR ship to recruiting site pharmacies for dispense and onward shipping.

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 (PUFA): placebo-controlled randomised parallel multi-centre clinical trial is due to commence recruitment in July 2021. The trial will be conducted according to Good Clinical Practice and Medicines and Healthcare products Regulatory Agency regulations. The trial is Sponsored by the Norfolk and Norwich University Hospitals NHS Foundation Trust (NNUH) with specified tasks delegated to the University of East Anglia (UEA). The UEA Norwich Clinical Trials Unit (NCTU) is a UKCRC registered trials unit and works with sites and institutes across the UK to deliver high quality studies. PUFA is a National Institute of Health Research project funded by the Efficacy and Mechanism Evaluation programme (NIHR number: 129910).

PUFA aims to determine whether n-3 poly-unsaturated fatty acid supplementation in people with non-steroidal exacerbated respiratory disease (N-ERD) can improve asthma control as measured by the asthma control questionnaire. A total of 98 participants from NHS Trusts across the UK will be recruited and complete study assessments at 3 monthly intervals for a total of 6 months. Recruitment is anticipated to last 15 months, completing in October 2022. Participants will be recruited throughout this period.

Participants will be randomised to receive either 6g / day of n-3 PUFA (eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) as 6 Omacor capsules (5.04g EPA + DHA) or matched soft-gel placebo (palm oil and soybean oil) capsules, to be taken once daily or in divided doses with food for 6 months.

The active treatment will be administered as 6g of EPA and DHA in a 1.3:1 ratio as six Omacor capsules. Active capsules will comprise 84% EPA + DHA. Active capsules should not be altered in any way i.e. must not be overencapsulated. Placebo treatment will comprise 6 soft-gel capsules containing palm oil and soybean oil in an 8:2 ratio. Placebo capsules must appear identical to the active capsules.

Trial treatment will be dispensed in bottles to each participant once during their involvement in the trial.

We anticipate that 58,900 active capsules and 58,900 placebo capsules will be dispensed in total.

Trial medication will need to be produced by a company with a current MIA(IMP) license and in accordance with Good Manufacturing Practice as described in Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2014 (Sub-section 2, Part 1, Annex 13). Trial medication will need be certified by a qualified person prior to release and labelled in accordance with Directive 2003/94/EC and Good Manufacturing Practice as described in Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2014 (Sub-section 2, Part 1, Annex 16).

The final trial medication will be shipped directly to participants homes. This may be direct to participant from the manufacturer or via the local NHS pharmacies. We are happy for suppliers to quote for either both or just one of these methods.