JPRN-jRCT1080224832已完成Unknown
Assessment of a telemedicine approach in the treatment of Japanese patients with COPD
GSK K.K.0 个研究点目标入组 84 人开始时间: 2019年8月16日最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- 入组人数
- 84
研究概览
简要总结
This study is the first study in which evaluated the usefulness and acceptance of telemonitoring for Japanese patients with COPD for a year. The actual use of telemedicine, the satisfaction and acceptance were collected, evaluated, and shown positive responses not only by patients but also by healthcare providers.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 40age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1.Participant must be capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
- •2.Participant must be more than 40 years of age inclusive at the time of signing the ICF.
- •3.An established clinical history of COPD in accordance with the definition by the American Thoracic Society/European Respiratory Society and JRS COPD and ACO guidelines.
- •4.Participant must be treated with inhaled LAMA and/or LABA as maintenance medication at the screening visit. LAMA/ LABA or ICS combinations will be allowed but inhaled triple therapy (e.g. ICS/LAMA/LABA) will not be allowed at baseline visit. Other short acting bronchodilators, roflumilast, systemic steroids, or antibiotics medications are permitted.
- •5.Participant may be male or female.
- •6.Patient who is having a lung function test result within last 12 months prior to study.
排除标准
- •1.Patients who are unable or unwilling to use the required telemonitoring device/ system.
- •2.Patients who are treated with ICS/LAMA/LABA triple combination at screening visit or during past 3 months before screening visit even open or closed combinations.
- •3.Patients who are treated with biologicals during past 6 months before screening visit such as omalizumab or mepolizumab.
- •4.Pregnancy: Women who are pregnant or lactating or are planning on becoming pregnant during the study.
- •5.Concurrently participating in another clinical trial, in which the participant has been or will be exposed to an investigational or a non-investigational vaccine/ product (pharmaceutical product)
研究者
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