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临床试验/NCT01567280
NCT01567280已完成不适用

International Cross-sectional and Longitudinal Assessment on Asthma Control (Liaison)

Chiesi Farmaceutici S.p.A.1 个研究点 分布在 1 个国家目标入组 8,111 人开始时间: 2012年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
8,111
试验地点
1
主要终点
Asthma Control Questionnaire score

研究概览

简要总结

The study design consists of a cross-sectional survey on the clinical characteristics of patients with asthma and their level of asthma control and current quality of life, and on a prospective evaluation of the rate of switch from the uncontrolled/poorly controlled condition to the status of controlled asthma. Asthma control will be based on the Asthma Control Questionnaire scoring system, that has been fully validated for use in both clinical practice and clinical trials and has strong discriminative properties which means that it can detect small differences between patients with different levels of asthma control and it is very sensitive to within-patient change in asthma control over time.

Quality of life as a reflection of the control of the disease, will also be evaluated by means of the Mini Asthma Quality of Life Questionnaire scoring system.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Inclusion criteria:
  • Written informed consent obtained.
  • Male or female adult (at least 18 years of age) patients with asthma diagnosed (according to GINA guidelines and confirmed by a chest physician) for at least 6 months.
  • Patients in treatment with the same antiasthmatic drugs in the last 4 weeks before enrolment.
  • Exclusion criteria:
  • Patients enrolled in clinical trial in the previous 4 weeks or subjects already admitted in this study.
  • Patients suffering from conditions and illnesses that might interfere with the study purpose, according to the investigator's evaluation.

排除标准

  • 未提供

结局指标

主要结局

Asthma Control Questionnaire score

时间窗: 3 months

Mini Asthma Quality of Life Questionnaire score

时间窗: 3 months

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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