LATE-BREAKING ABSTRACT: Effects of a fixed dose once-daily triple drug combination in smokers and non-smokers with COPD

GOLD 2016 strategy document suggests that the use of triple therapy improves lung function and quality of life and may further reduce exacerbations in patients with COPD compared to the mono or dual therapy. The fixed dose combination of Tiotropium/Formoterol/Ciclesonide [TFC; Triohale ® ] is the only triple therapy available for the treatment of COPD. We assessed the real world effectiveness and safety of once-daily TFC (18/12/400 mcg) via DPI or MDI in patients with COPD. This 24 Wk, open-label, prospective, non-comparative, multicentre, real world study enrolled patients with COPD requiring triple drug therapy as assessed by physician. The primary endpoint was mean change from baseline in pre-dose FEV 1 at Wk 24. Pre and post dose (30 mins) FEV 1 , FVC, CAT score, and safety were also evaluated. Post- hoc analysis was done to evaluate the effects of TFC in smokers (S) and non-smokers (NS) with COPD. Of 297 patients enrolled [mean age 61.40 yrs; 84.84% males; 55.22% smokers and post dose FEV 1 % predicted 36.4±15.19], 267 completed the study. Mean change in pre-dose FEV 1 from baseline to Wk 24 was significant (+0.58±0.6L, 95% CI (0.51, 0.65), p 1 in S (mean change +0.20±0.43L, 95%CI (0.13, 0.27), p 1 and FVC, and CAT score were significant across all visits. TFC was well tolerated. TFC (Triohale) significantly improved lung function and symptoms in patients with COPD, independent of their smoking history.