Jahnz-Różyk Karina, Szepiel Paweł
Department of Immunology and Clinical Allergology, Military Institute of Medicine, Warsaw, Poland.
Boehringer Ingelheim Sp. z o.o., Warsaw, Poland.
Int J Chron Obstruct Pulmon Dis. 2015 Mar 18;10:613-23. doi: 10.2147/COPD.S77144. eCollection 2015.
Long-acting inhaled bronchodilators, including anticholinergic tiotropium, are recommended for the maintenance therapy of chronic obstructive pulmonary disease (COPD). It has been shown in a number of studies that treatment with tiotropium alleviates symptoms, improves exercise tolerance, health status, and reduces exacerbations in patients with moderate to very severe stage COPD.
The aim of this noninterventional study was to observe the early effects of the maintenance treatment with tiotropium in patients with COPD of different severities, who had been previously treated on a regular basis, or as required, with at least one short-acting bronchodilator, in a real-life setting in Poland. The effect of the treatment was assessed through the collection of COPD Assessment Test (CAT) data.
The MATHS clinical study was an observational, noninterventional, open-label, prospective, uncontrolled, single-arm, postmarketing, surveillance, real-life study conducted with the involvement of 236 pulmonology clinics based in Poland. The tiotropium observational period was 3 months. The health and COPD status was measured with the CAT questionnaire. The primary efficacy endpoint was the mean change from the baseline in the total CAT score at the end of the 3-month observational period.
Patients treated with 18 μg of tiotropium once daily for 3 months showed a statistically significant result, with a clinically meaningful mean reduction (improvement) of 7.0 points in the total CAT score. The improvement was slightly greater in patients with more severe COPD; the mean change in the total CAT score was 7.6 in the subgroup of patients with more severe COPD and 6.7 points in the subgroup of patients with moderate COPD.
Results of this real-life study provide further support for the use of tiotropium as a first-line maintenance treatment for patients with COPD of different severities in Poland.
长效吸入性支气管扩张剂,包括抗胆碱能药物噻托溴铵,被推荐用于慢性阻塞性肺疾病(COPD)的维持治疗。多项研究表明,噻托溴铵治疗可缓解症状、提高运动耐量、改善健康状况,并减少中度至非常严重阶段COPD患者的病情加重。
这项非干预性研究的目的是观察在波兰的实际临床环境中,噻托溴铵维持治疗对不同严重程度的COPD患者的早期效果,这些患者此前曾定期或按需接受至少一种短效支气管扩张剂治疗。通过收集慢性阻塞性肺疾病评估测试(CAT)数据来评估治疗效果。
MATHS临床研究是一项观察性、非干预性、开放标签、前瞻性、非对照、单臂、上市后监测的实际临床研究,由波兰的236家肺病诊所参与。噻托溴铵观察期为3个月。使用CAT问卷测量健康状况和COPD病情。主要疗效终点是3个月观察期结束时CAT总分相对于基线的平均变化。
每天一次使用18μg噻托溴铵治疗3个月的患者显示出具有统计学意义的结果,CAT总分在临床上有意义地平均降低(改善)了7.0分。在COPD更严重的患者中改善稍大;在更严重COPD患者亚组中,CAT总分的平均变化为7.6分,在中度COPD患者亚组中为6.7分。
这项实际临床研究的结果为在波兰将噻托溴铵用作不同严重程度COPD患者的一线维持治疗提供了进一步支持。