Effects of Fluticasone furoate/Vilanterol (FF/VI) on Patient Reported Outcomes (PRO): The Salford Lung Study in Asthma (SLS Asthma)

Rationale SLS asthma, a 12month open label, randomized controlled trial conducted in UK primary care compared effectiveness & safety of initiating FF/VI 100(200)µg/25 μg with continuing optimized usual care (UC) in patients with symptomatic asthma. Patients initiated with FF/VI were significantly more likely to be responders based on Asthma Control Test (ACT) vs. UC [Woodcock et al. Lancet 2017]. Patients initiated with FF/VI were significantly more likely to be responders in Asthma Quality of Life Questionnaire (AQLQ) total score (≥ 0.5point increase from baseline) & demonstrated significantly greater decreases in composite Work Productivity & Activity Impairment Questionnaire Asthma (WPAI) at Week 52 vs. UC. The current analysis describes treatment benefits of FF/VI vs. UC for individual AQLQ domains & WPAI scores across patient subgroups in SLS asthma.

Methods Patients ≥ 18 years with symptomatic asthma maintained on inhaled corticosteroids (ICS) or ICS/longacting β2 agonist (LABA) completed AQLQ at baseline (randomization), Week 24 & Week 52 & WPAI at baseline & Week 52. The changes from baseline at Week 52 in AQLQ domains & WPAI were evaluated in the overall intent to treat (ITT) population (all patients who received ≥ 1 prescription of study medication) & in subgroups of the ITT whose physician recommended-treatment was ICS only or ICS/LABA at baseline. Patients were classified as AQLQ responders if they had an increase from baseline of ≥ 0.5.

Results Across all subgroups analyzed (ITT, ICS-only subgroup, ICS/LABA subgroup) the proportions of responders for AQLQ total score and for each individual AQLQ domain were higher with FF/VI vs. UC at Week 52 (all p < 0.001) ([Fig. 1]). Patients initiated with FF/VI vs. continuing UC had significantly greater percentage decreases in overall work (ITT: 6.7 vs. 4.0 diff 2.8 [95% CI:4.4,1.1] p < 0.001) & activity impairment (ITT: 10.4 vs. 5.9 diff 4.5 [95% CI: 5.9, 3.2] p < 0.001). Results were similar across all subgroups.

Statistical analysis of AQLQ responders by individual domains with FF/VI versus UC (Week 52 data).

Conclusion The benefit of initiating FF/VI vs. continuing UC was observed for AQLQ total score, all individual AQLQ domains and WPAI scores irrespective of patient subgroup.

GSK funded study: HZA115150; NCT01706198

The poster will be presented as an ENCORE.