Outcome | Outcome measure | Key criteria |
---|---|---|
Feasibility | ||
Recruitment rate | n participants enrolled in 52 weeks | 40 participants enrolled after 52 weeks. |
Retention rate | n participants completing intervention | 80% of all enrolled participants to complete |
Supplement adherence rate | Change in RBC LCn-3PUFA content (expressed as percentage of total fatty acids) Capsule count at study completion | ≥ 2% increase in percent of LCn-3PUFA in RBC ≥ 80% of capsules consumed |
Refusal rate | n identified volunteers who decline to participate/be randomised | |
Time lost to exacerbation | n days, self-reported exacerbation | |
Clinical (proposed in original protocol) | ||
Safety | Reported symptoms from supplement | |
Effect size | Inflammatory biomarkers, spirometry, impulse oscillometry (IOS), gas transfer and plethysmography, dyspnoea (Dyspnoea-12 questionnaire and visual analogue scale), functional exercise capacity (six-minute walk test), and well-being (hospital anxiety and depression scale (HADS) and chronic respiratory questionnaire (CRQ)) | A positive moderate effect size (≥ 0.5) for at least CRP, dyspnoea and FEF25–75. |