跳至主要内容
临床试验/NCT04878367
NCT04878367已完成不适用

Behavioral Interventions to Reduce Particulate Matter Exposure in Patients With COPD

Asan Medical Center2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2021年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
120
试验地点
2
主要终点
SGRQ-C

研究概览

简要总结

It is a prospective, multi-institutional clinical study and targets patients diagnosed with chronic obstructive pulmonary disease. About 120 subjects (35 at Ilsan Paik Hospital, 35 at Severance Hospital, and 50 at Asan Medical Center in Seoul) will be subject to a random allocation of 1:1. The arbitration group implements living rules for responding to fine dust, supports air purifiers, and only general guidance is implemented in the non-property group. Patients are recruited from Asan Medical Center in Seoul (Songpa-gu, Seoul), Severance Hospital ( Seodaemun-gu, Seoul), and Ilsan Paik Medical Center (Goyang, Gyeonggi-do) for 12 months. During outpatient visits, lung function tests and airway resistance tests shall be conducted, and surveys presented in the research plan shall be conducted.

详细描述

It is a prospective and multi-institutional clinical study targeting patients with chronic obstructive pulmonary disease in general.

A total of 120 COPD patients will be recruited from three institutions: Asan Medical Center, Severance Hospital, and Ilsan Paik Hospital. (60/30/30 expected) A panel of COPD patients is established to conduct prospective studies, and measures to mediate recurrence and deterioration of adult chronic respiratory diseases due to exposure to fine dust are presented. Improvement of the lifestyle of the arbitration forces. Detailed research methods such as air purifier support are presented in the research plan.

In addition, a fine dust measurement researcher visits each household to measure indoor fine dust concentration. The measurement method of fine dust concentration will be using the process test method, IoT-based sensors, and direct-to-read measuring devices to measure Air Korea's air pollution. Detailed visit timing and methods are carried out in the manner specified in the research plan.

We collect sputum at every visit and blood at the last visit.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
40 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 40 years of age or older
  • Waste function test results show FEV1/FVC<0.7, FEV1 <80% of forecast

排除标准

  • Patients under 18 years of age with changes in medication (such as inhalants).
  • Older people over 80 years of age.
  • People with no respiratory symptoms with mMRC
  • Who doesn't understand a simple explanation for fine dust exposure devices.
  • Someone who disagrees with the study.

结局指标

主要结局

SGRQ-C

时间窗: 12 months

Quality of life

CAT

时间窗: 12 months

Quality of life

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sei Won Lee

associate professor

Asan Medical Center

研究点 (2)

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