David Geffen School of Medicine, University of California, Los Angeles, CA.
Brigham and Women's Hospital, Boston, MA.
Chest. 2013 Aug;144(2):490-497. doi: 10.1378/chest.12-2613.
Disease progression in COPD is associated with a decline in exercise performance over time. We assessed whether tiotropium might mitigate this by determining its effect on treadmill endurance time (ET) over 2 years.
This was a randomized, double-blind, placebo-controlled trial of tiotropium, 18 μg daily, in patients with COPD (FEV1/FVC < 70%; postbronchodilator FEV1 < 65%). The primary end point was ET at 90% of baseline maximum work rate at 96 weeks. Secondary end points were ET at other visits, ET by smoking status, spirometry, and St. George's Respiratory Questionnaire (SGRQ).
A total of 519 patients were randomized (tiotropium 260, placebo 259). Mean age was 65 years, 77% were men, 34% were continuing smokers, and mean FEV1 was 1.25 L (44% predicted). Significantly more patients discontinued placebo (hazard ratio [95% CI], 0.61 [0.44-0.83]). Baseline ET was 301 s (improvement tiotropium/placebo was 13% overall; P = .009; 18% at 48 weeks, P = .004; 13% at 96 weeks, P = .106). In patients with baseline ET between 2 and 10 min (n = 404), improvement at 96 weeks was 19% (P = .04). Current smokers had higher ET with tiotropium vs placebo (P = .018). FEV1/FVC improved with tiotropium (P < .01). SGRQ total score at 96 weeks improved with tiotropium vs placebo by 4.03 units (P = .007).
Treadmill ET was numerically greater over 2 years with tiotropium vs placebo. However, the 96-week difference was not statistically significant. Spirometry and health status also improved with tiotropium over 2 years, attesting to the benefits of long-acting bronchodilator therapy.
ClinicalTrials.gov; No.: NCT00525512; URL: www.clinicaltrials.gov.
COPD 患者的疾病进展与随时间推移的运动能力下降有关。我们评估噻托溴铵是否可以通过确定其对 2 年内跑步机耐力时间（ET）的影响来减轻这种情况。
这是一项噻托溴铵（18μg，每日 1 次）治疗 COPD 患者的随机、双盲、安慰剂对照试验（FEV1/FVC < 70%；支气管扩张剂后 FEV1 < 65%）。主要终点是 96 周时 90%基线最大做功率时的 ET。次要终点是其他时间点的 ET、吸烟状态、肺量计和圣乔治呼吸问卷（SGRQ）的 ET。
共 519 例患者随机分组（噻托溴铵 260 例，安慰剂 259 例）。平均年龄为 65 岁，77%为男性，34%为持续吸烟者，平均 FEV1 为 1.25 L（44%预计值）。更多的患者停用了安慰剂（风险比[95%CI]，0.61 [0.44-0.83]）。基线 ET 为 301 s（噻托溴铵/安慰剂的总体改善为 13%；P =.009；48 周时为 18%，P =.004；96 周时为 13%，P =.106）。在基线 ET 为 2 至 10 分钟的患者（n = 404）中，96 周时的改善为 19%（P =.04）。与安慰剂相比，当前吸烟者的 ET 更高（P =.018）。噻托溴铵治疗后 FEV1/FVC 改善（P <.01）。96 周时，SGRQ 总分较安慰剂组改善 4.03 分（P =.007）。
与安慰剂相比，噻托溴铵在 2 年内跑步机 ET 有数值上的提高。然而，96 周的差异没有统计学意义。2 年内，肺量计和健康状况也随着噻托溴铵治疗而改善，证明了长效支气管扩张剂治疗的益处。
ClinicalTrials.gov；编号：NCT00525512；网址：www.clinicaltrials.gov。
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