Abstract

Rationale:Nocturnal symptoms related to COPD have the potential to impact quality of life in patients with moderate-severe COPD. In this abstract we evaluate TRITRIAL results related to sleep quality in COPD patients treated with extrafine triple therapy. 

Methods TRITRIAL is a 12-month, multicenter, prospective, longitudinal observational study conducted to evaluate the effect of the extrafine BDP/FF/G on health status (CAT score) of COPD patients ? 40 years of age and a history of at least 1 moderate or severe exacerbation. Prespecified secondary outcomes included night-time respiratory symptoms assessed via CAT questionnaire and CASIS 7-item questionnaire. Both questionnaires were electronically self-administered. Higher scores represented greater sleep deterioration. 

Results A total of 656 patients, aged 71.2 years on average (SD 9) were enrolled. CAT score at baseline was 22.8, at 12 months was 16.4 with a reduction of 6.3 points(p<0.0001). The domain related to sleep quality at baseline was 2.54 vs 1.99 at 6 months [mean difference-0.55(p<0.0001)] and 1.69 at 12 months [mean difference -0.85 (p<0.0001)]. CASIS total score at the baseline was 41.1vs 36.1 at 6-month follow-up [mean difference -4.99(p<0.0001)]and 31.8[mean difference -9.33 (p<0.0001)] at 12-month follow-up.The quality of sleep became better from baseline to follow-up visits.

Conclusions The current study showed that extrafine BPD/FF/G significantly improved quality of sleep, over time, in patients with moderate to severe COPD. Results were consistent from both CAT and CASIS perspectives collected from patients with COPD.