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The investigators randomized the patients to a 50-g dose of NVA237, 18-μg of placebo, and 18-g of tiotropium bromide(136310-93-5), in a 2: 1: 1 ratio, for a 52-week evaluation. The primary end point was a 1-second forced expiratory volume (FEV1) for the 12-week treatment period.

Eventually 1,066 patients were randomized and 810 completed the study. At 12 weeks, the FEV1 in the glycopyrrolate(NVA237) group increased significantly by 97 ml (95% CI 64.6-130.2; p <0.001) and in the tiotropium bromide(136310-93-5) group by 83 ml (95% CI 45.6-121.4; p <0.001). P <0.001) and health status (52-week St. George Respiratory Questionnaire; p <0.001) compared with placebo, which significantly improved the risk of acute exacerbations of moderate to severe COPD (26-week short breathlessness index; Significantly reduced by 34% (P = 0.001), while reducing the use of first aid medications (p = 0.039). The difference between the NVA237-placebo and tiotropium-placebo groups was approximately equal. The safety of the three groups was basically the same.

The researchers concluded that compared with placebo, NVA237 50 micrograms can significantly improve lung function, dyspnea, health status, acute exacerbation of the disease and the use of emergency medicine, the effect is roughly equivalent to tiotropium bromide(136310-93-5). NVA237 may be an alternative to LAMA in patients with COPD.

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