临床试验/NCT01693471

NCT01693471已完成不适用

Survey on the Effect of Health Related QOL Associated With Compliance of Carbocisteine in Asthma Patients Study (SEARCH Study)

Kyorin Pharmaceutical Co.,Ltd1 个研究点分布在 1 个国家目标入组 179 人开始时间: 2012年9月最近更新: 2013年3月1日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: Kyorin Pharmaceutical Co.,Ltd
入组人数: 179
试验地点: 1
主要终点: Score of SF-36

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The objectives of this study are to investigate the influence on HR-QOL (SF-36 v2) resulting from the compliance of MUCODYNE Tablets or MUCODYNE DS (Dry Syrup) 50% in asthma patients whose control levels are partly controlled or uncontrolled.

详细描述

Period: 2012-2013 Observation Time: 0 week, 4 week

Matters investigated:

QOL determination using SF-36 v2
Medication compliance (VAS scale)
Gender, age, diagnosis, asthma subtype, severity, duration of disease, level of asthma control, concomitant drugs, comorbidities, smoking, alcohol, work

研究设计

研究类型: Observational
观察模型: Cohort
时间视角: Prospective

入排标准

年龄范围: 20 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Male and female patients ≥ 20 years of age
•Outpatients
•Patients with mild or moderate persistent asthma
•Patients with phlegm
•Patients whose levels of asthma control are partly controlled or uncontrolled
•Patients who are planned to treat MUCODYNE
•Patients who voluntarily submitted written consent forms upon participation in this study

排除标准

•Patients with a history of adverse reactions to carbocisteine
•Patients with serious cardiac, hepatic, renal, pulmonary, or hematological disease
•Patients with the possibility of pregnancy or suspected pregnancy
•Patients with complication of malignancy
•Current smoker
•Patients with definitive diagnosis for COPD
•Other patients whom investigators or subinvestigators considered inappropriate to participate in this study

结局指标

主要结局

Score of SF-36

时间窗: 4 week

次要结局

HR-QOL condition of asthma patients with phlegm(0 week)
Medication compliance: measured by patient response to visual analog scale(4 week)
Relation between a medication compliance measured by patient response to visual analog scale and change of HR-QOL from baseline at 4 weeks(0 week, 4 week)

研究者

发起方

Kyorin Pharmaceutical Co.,Ltd

申办方类型

Industry

责任方

Sponsor

研究点 (1)

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