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Clinical Trial on Education Method of Fluterol® Inhalation Inhaler for Asthma Control

2018年2月21日 更新者:Hanmi Pharmaceutical Company Limited

A Multi-center, Randomized, Interventional, Open, Phase Ⅳ Clinical Trial on Education Method of Fluterol® Inhalation Capsule 250/50 μg Inhaler for Asthma Control in Patients With Partly Controlled Asthma

A multi-center, randomized, open, non-inferiority, Phase 4 study

研究概览

详细说明

A Multi-center, Randomized, Interventional, Open, Phase Ⅳ Clinical Trial on Education Method of Fluterol® Inhalation Capsule 250/50 μg Inhaler for Asthma Control in Patients with Partly Controlled Asthma

研究类型

介入性

注册 (实际的)

184

阶段

  • 第四阶段

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

19年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  1. Adult at the age of 19 or older.
  2. Patient with partially controlled asthma (Asthma Control Test score 16~24)
  3. Written informed consent to study participation.

Exclusion Criteria:

  1. History of hypersensitivity reactions to the investigational product (Fluterol®) or any of its component.
  2. Cardiac tachyarrhythmia.
  3. contreated respiratory fungal, bacterial, or tuberculous infection.
  4. Moderate to severe bronchiectasis
  5. Planned use of the investigational product (Fluterol®) as primary treatment for patients with status asthmaticus, patients with an asthmatic crisis*, or patients with chronic obstructive pulmonary disease requiring intensive treatment.

    • Asthmatic crisis: acute exacerbation of asthma meeting at least one of the followings.
    • Asthma related emergency room visit or hospitalization within 2 weeks prior to screening.
    • Administration of systemic steroids within 2 weeks prior to screening.
    • Inhalation of rescue medication at least 10 times/day for the treatment of acute exacerbation of asthmatic symptoms within 2 weeks prior to screening.
  6. Administration of systemic steroids within 2 weeks prior to screening.
  7. Hypersensitivity reactions to lactose and milk.
  8. Pregnant and lactating women or women who are planning to be pregnant or who are unwilling to use appropriate methods of contraception during the study.
  9. Previous use of the investigational product (Fluterol®) or a similar inhaler (Onbrez, Spiriva) at least once.
  10. Participation in another clinical study for drugs or medical devices to receive the investigational product or undergo a procedure using the investigational device within 4 weeks prior to participation in this study.
  11. Individual considered by the he investigator to be inappropriate for study participation due to other reasons.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:Experimental group (one-way education)

Experimental group (one-way education)

  • Fluterol Inhalation Capsule (fluticasone propionate 250 μg, salmeterol xinafoate 72.5 μg)
  • video based education
'Fluterol Inhalation Capsule(fluticasone propionate 250 μg, salmeterol xinafoate 72.5 μg) : one-way education'
其他名称:
  • 基于视频的教育
有源比较器:Control group(two-way education)

Control group(two-way education)

  • Fluterol Inhalation Capsule (fluticasone propionate 250 μg, salmeterol xinafoate 72.5 μg)
  • direct education
'Fluterol Inhalation Capsule(fluticasone propionate 250 μg, salmeterol xinafoate 72.5 μg) : two-way education'
其他名称:
  • direct education

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Percent change in Forced expiratory volume 1 sec (% prediction) at Week 12 from baseline in each group.
大体时间:Week 12
method of assessment:Forced expiratory volume
Week 12

次要结果测量

结果测量
措施说明
大体时间
percent change in Forced expiratory volume 1 sec (% prediction) at Week 4 from baseline in each group.
大体时间:Week 4
method of assessment:Forced expiratory volume
Week 4
Change in asthma control (ACT) at Weeks 4 and 12 from baseline in each group.
大体时间:Weeks 4 and 12
method of assessment: Check list
Weeks 4 and 12
Change in inhaler technique score at Weeks 4 and 12 from baseline in each group
大体时间:Weeks 4 and 12
method of assessment: Check list
Weeks 4 and 12
Number of critical errors at Weeks 4 and 12 in each group.
大体时间:Weeks 4 and 12
method of assessment: Check list
Weeks 4 and 12
Proportion of subjects with optimal inhaler technique at Weeks 4 and 12 in each group.
大体时间:Weeks 4 and 12
method of assessment: Check list
Weeks 4 and 12
Satisfaction for the inhalation drug at Weeks 4 and 12 in each group (FSI-10 score).
大体时间:Weeks 4 and 12
method of assessment: Check list
Weeks 4 and 12
Adherence rate (%) at Weeks 4 and 12 in each group.
大体时间:Weeks 4 and 12
method of assessment: drug administration calculation
Weeks 4 and 12
Safety endpoint:AEs(adverse events), vital signs, incidence rate of acute exacerbation.
大体时间:baseline(day1),weeks 4 and weeks12
occur frequency of adverse events and incidence rate of acute in each group, vital signs: blood pressure and pulse
baseline(day1),weeks 4 and weeks12

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Byoung Whui Choi、Chung-Ang University Hosptial, Chung-Ang University College of Medicine

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2015年10月8日

初级完成 (实际的)

2016年9月1日

研究完成 (实际的)

2017年5月10日

研究注册日期

首次提交

2017年3月31日

首先提交符合 QC 标准的

2017年4月6日

首次发布 (实际的)

2017年4月12日

研究记录更新

最后更新发布 (实际的)

2018年2月23日

上次提交的符合 QC 标准的更新

2018年2月21日

最后验证

2018年2月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

one-way education的临床试验

3
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