Comparison of tiotropium plus fluticasone propionate/salmeterol with tiotropium in COPD: a randomized controlled study.

The combination of tiotropium and fluticasone propionate/salmeterol (FSC) is commonly used to treat chronic obstructive pulmonary disease (COPD), but no study had evaluated the effectiveness of tiotropium plus FSC with 250 μg of fluticasone propionate. Our aim was to assess whether tiotropium (18 μg once daily) plus FSC (250/50 μg twice daily) provides better clinical outcomes compared to tiotropium monotherapy. In this 24-week, randomized, open label, multicenter two-arm parallel study, 479 patients received tiotropium plus FSC (n = 237) or tiotropium alone (n = 242). After 24 weeks of treatment, the triple-inhaled treatment group had a significant improvement in pre-bronchodilator FEV(1) (L) compared to the tiotropium-only group (0.090 L vs. 0.038 L; P = 0.005). Regarding health-related quality of life, the mean change in total score on the St. George's Respiratory Questionnaire for COPD patients (SGRQ-C) was -6.6 points in the tiotropium plus FSC group, but -1.5 points in the tiotropium-only group (P = 0.001). In the subgroup of GOLD stage II patients with COPD, treatment with tiotropium plus FSC also improved FEV(1) compared to tiotropium alone (0.088 L vs. 0.030 L; P = 0.011) and improved the total SGRQ-C score than tiotropium alone (-4.5 points vs. -1.0 points, respectively). This triple-inhaled treatment approach did not induce more adverse events, such as pneumonia. Over the course of 24 weeks, FSC (250/50 μg twice daily) added to tiotropium provided greater improvement in lung function and quality of life in patients with COPD (FEV(1) ≤ 65%) than tiotropium alone.

Jung KS ，Park HY ，Park SY ，Kim SK ，Kim YK ，Shim JJ ，Moon HS ，Lee KH ，Yoo JH ，Lee SD ，Korean Academy of Tuberculosis and Respiratory Diseases study group ，Korea Chronic Obstructive Pulmonary Disease study group ... -  《-》

Changes in lung function and health status in patients with COPD treated with tiotropium or salmeterol plus fluticasone.

Kurashima K ，Hara K ，Yoneda K ，Kanauchi T ，Kagiyama N ，Tokunaga D ，Takayanagi N ，Ubukata M ，Sugita Y ... -  《-》

Benefits of adding fluticasone propionate/salmeterol to tiotropium in moderate to severe COPD.

Combining maintenance medications with different mechanisms of action may improve outcomes in COPD. In this study we evaluated the efficacy and safety of fluticasone/salmeterol (FSC) (250/50 mcg twice daily) when added to tiotropium (18 mcg once daily) (TIO) in subjects with symptomatic moderate to severe COPD. This was a 24-week, randomized, double-blind, parallel group, multi-center study. Subjects 40 years or older with cigarette smoking history ≥10 pack-years and with the diagnosis of COPD and post-bronchodilator FEV(1) ≥40 to ≤ 80% of predicted normal and FEV(1)/FVC of ≤0.70 were enrolled. Following a 4-week treatment with open-label TIO 18 mcg once daily, subjects were randomized in a double-blind fashion to either the addition of FSC 250/50 DISKUS twice daily or matching placebo. The primary efficacy endpoint was AM pre-dose FEV(1) and secondary endpoints included other measures of lung function, rescue albuterol use, health status and exacerbations. The addition of FSC to TIO significantly improved lung function indices including AM pre-dose FEV(1), 2 h post-dose FEV(1), AM pre-dose FVC, 2 h post-dose FVC and AM pre-dose IC compared with TIO alone. Furthermore, this combination was superior to TIO alone in reducing rescue albuterol use. However, there were no significant differences between the treatment groups in health status or COPD exacerbations. The incidence of adverse events was similar in both groups. The addition of FSC to subjects with COPD treated with TIO significantly improves lung function without increasing the risk of adverse events. NCT00784550.

Hanania NA ，Crater GD ，Morris AN ，Emmett AH ，O'Dell DM ，Niewoehner DE ... -  《-》

A pilot study to assess the effects of combining fluticasone propionate/salmeterol and tiotropium on the airflow obstruction of patients with severe-to-very severe COPD.

Cazzola M ，Andò F ，Santus P ，Ruggeri P ，Di Marco F ，Sanduzzi A ，D'Amato M ... -  《PULMONARY PHARMACOLOGY & THERAPEUTICS》

[Combination of inhaled salmeterol/fluticasone and tiotropium in the treatment of chronic obstructive pulmonary disease: a randomised controlled trial].

Fang LZ ，Liang X ，Zhang JQ ，Liu L ，Fu WP ，Zhao ZH ，Dai LM ... -  《-》