RATIONALE To assess impact of extrafine single inhaler triple BDP/FF/G on patient-reported outcomes in a real-world setting, a non-interventional study was conducted in Italy.

OBJECTIVE To evaluate the effectiveness of BDP/FF/G via several e-PROs, including CAT questionnaire, as well as adherence, health-related quality of life and device satisfaction over the period of 12 months.

METHODS TRITRIAL was a prospective observational study in patients with COPD ? 40 years of age with a documented ? 1 moderate or severe exacerbation in the previous 12 months, CAT score >10, starting physician-prescribed treatment with extrafine BDP/FF/G. Adherence was measured with TAI-10, quality of life with EQ-5D-5L, and device evaluation using 8 questions designed to determine the ease of use and patient satisfaction with the inhaler. Higher scores indicate a better outcome.

RESULTS A total of 656 COPD (68% males) patients, mean age 71 were analyzed. Primary endpoint was achieved with improvement in CAT score of -6.3 (p<0.0001). For EQ-5D-5L, EQ index varied from a baseline 0.70 to 0.81 at 12 months; EQ-VAS from 55.1 to 63.1 (p<0.0001 for both). Baseline CASIS was 41.1 vs 31.8 at 12 months (p<0.0001); TAI-10 score was 46.4 vs 47.8 (p<0.0001), with a good adherence achieved in 58% of patients. Poor adherence was reduced from an initial 30.1% of patients to 18.3% after 12 months. Considering a maximum score of 40 for patients who positively answer in terms of satisfaction, baseline score was 35.2 vs 36.2 at 12 months (p=0.0003).

CONCLUSIONS Extrafine triple therapy significantly improved health status and HRQoL and other e-PROs of COPD patients in a real-world setting in Italy.