Your Yourlocation: Home > The use of tiotropium bromide(136310-93-5) did not exceed 5 μg daily clinical trials is safity

The five clinical studies mentioned in the meta-analysis of Singh et al. have ended and published in 2009. The limitations of this meta-analysis are: (1) The main analysis of the mixed dose of tiotropium bromide(136310-93-5) inhalation of two doses (5 μg, 10 μg) of data, and 10 μg of inhalation of tiotropium in the global (2) The meta-analysis did not include another study that met its analytical requirements (Study No. 1205.14).

The article also conducted a sensitivity analysis. In the susceptibility analysis, 5 μg of inhaled tiotropium bromide(136310-93-5) did not increase the risk of death in COPD patients compared with placebo. This conclusion is consistent with the data adopted by Governments.

Zhong Shi introduced the study mentioned tiotropium bromide inhalation agent has not yet been listed in China. At present, COPD patients in China can obtain dry powder inhalation of tiotropium bromide, and the long-term safety and efficacy of the drug has been confirmed by large clinical studies (including UPLIFT and POET-COPD).

To further clarify the efficacy and safety of inhalation of tiotropium bromide, the drug manufacturer has initiated a randomized double-blind, long-term clinical study (TIOSPIR) that incorporates about 17,000 patients who received randomized trials. The study was approved by the Food and Drug Administration (FDA), including the US Food and Drug Administration (FDA), and the US Ethics Committee.

As part of the regulatory process, an independent Data Security Audit Committee (DSMB) reviewed the TIOSPIR study on June 14, and after reviewing the safety and efficacy of the study, the committee recommended that the study continue The

In another study that was aimed at observing the efficacy and safety of tiotropium bromide (5 μg) in patients with COPD, subgroup analysis specifically targeted at the Chinese population was not found in the treatment group compared with the placebo group An imbalance in the death of a patient.

At present, all Chinese patients involved in the study of nitric acid inhalation tiotropium bromide(136310-93-5) in COPD efficacy and safety of clinical trials are Ⅲ and later clinical research, involving the use of tiotropium bromide(136310-93-5). The dose does not exceed 5 μg per day. 10 μg dose is at risk of increasing mortality and is worth exploring further.

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