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Validation of Questionnaire and Assessment of Patient Satisfaction for Budesonide/Formoterol Fix Combination Dry Powder Inhalers (DPI) in Chronic Obstructive Pulmonary Disease (COPD)

2012年10月15日更新者：AstraZeneca

Validation of Questionnaire and Assessment of Patient Satisfaction for Budesonide/Formoterol Fix Combination DPI in COPD

The aim of this study is to describe patient preferences on budesonide/formoterol fix dose combination for the treatment of their COPD, and to find those factors more strongly associated to a better attitude to medication.

研究概览

地位

完全的

条件

慢性阻塞性肺疾病 (COPD)

详细说明

Validation of questionnaire and assessment of patient satisfaction for budesonide/formoterol fix combination DPI in COPD

研究类型

观察性的

注册 (实际的)

446

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

火鸡
- - Adana、火鸡
    - Research Site
  - Afyon、火鸡
    - Research Site
  - Ankara、火鸡
    - Research Site
  - Ayd?n、火鸡
    - Research Site
  - Balikesir、火鸡
    - Research Site
  - Bartin、火鸡
    - Research Site
  - Cankiri、火鸡
    - Research Site
  - Elazig、火鸡
    - Research Site
  - Gaziantep、火鸡
    - Research Site
  - Istanbul、火鸡
    - Research Site
  - Izmir、火鸡
    - Research Site
  - Kayseri、火鸡
    - Research Site
  - Kocaeli、火鸡
    - Research Site
  - Konya、火鸡
    - Research Site
  - Manisa、火鸡
    - Research Site
  - Mersin、火鸡
    - Research Site
  - Rize、火鸡
    - Research Site
  - Sakarya、火鸡
    - Research Site
  - Samsun、火鸡
    - Research Site
  - Yozgat、火鸡
    - Research Site

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

40年及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Patients of both sexes ≥ 40 years of age, diagnosed with COPD (according to ICD-10 criteria) and receiving budesonide/formoterol fix dose combination treatment by means of inhaler devices. The first prescription must be given at least 3 months prior to the study start and patient inclusion.

描述

Inclusion Criteria:

Provision of subject informed consent and to be an outpatient
Clinical diagnosis of COPD according to ICD-10 classification, females and males, aged ≥ 40 years
To be prescribed a fixed dose combination of inhaled budesonide/formoterol fix combination at least 3 months before the study start

Exclusion Criteria:

Pregnancy for women
Use of inhaled medication via a metered dose inhaler (pMDI)
Currently participating in randomized clinical trials and being included in this study once

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

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
Feeling of Satisfaction with Inhaler (FSI-10) Questionnaire in COPD Turkish population. 大体时间：During 1 month, up to September 2012	The FSI-10 is a self-completed 10-item questionnaire to assess patient opinions regarding ease or difficulty of use, portability, and usability of devices for delivery of inhaled medications. Each of the 10 items has 5 response options from poorer to greater ease of use, scored 1 to 5, respectively. The minimum score is 10 whereas the maximum is 50.	During 1 month, up to September 2012

次要结果测量

结果测量	措施说明	大体时间
Socio-demographics profile 大体时间：During 1 month, up to September 2012	Socio-demographics parameters: Age; Gender; Educational level; Place of residence (urban / rural); Living alone or accompanied.	During 1 month, up to September 2012
Clinical characteristics 大体时间：During 1 month, up to September 2012	Clinical characteristics parameters:Current disease grade; Date of COPD diagnosis	During 1 month, up to September 2012
Treatment-related information 大体时间：During 1 month, up to September 2012	Date of first prescription for Turbuhaler; Concomitant treatments for COPD	During 1 month, up to September 2012
Inhaler use 大体时间：During 1 month, up to September 2012	Specifically for evaluating real-life patterns of use and usage knowledge of the dry-powder inhaler (Turbuhaler) that delivers budesonide / formoterol fix combination, a specific checklist of the key features of the inhalation technique.Preference with the inhaler she/he is using will be assessed based on patient reported outcomes.	During 1 month, up to September 2012
Site characteristics 大体时间：During 1 month, up to September 2012	Type of the hospital: state, university, private	During 1 month, up to September 2012

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。

赞助

AstraZeneca

调查人员

研究主任：Mujgan Ates, DR、AZ MC Turkey
首席研究员：Akin Kaya, PROF.DR.、Ankara University Faculty of Medicine, Chest Diseases Department

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

2012年8月1日

初级完成 (实际的)

2012年9月1日

研究完成 (实际的)

2012年9月1日

研究注册日期

首次提交

2012年7月19日

首先提交符合 QC 标准的