Salmeterol/Fluticasone Easyhaler in the Treatment of Asthma and COPD; a Non-interventional Switch Study to Evaluate the Impact on Clinical Effects, Patient's Satisfaction, Preference and Use of Easyhaler
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 231
- 试验地点
- 1
- 主要终点
- Asthma Control Test (ACT)
研究概览
简要总结
A non-interventional study to assess the clinical effectiveness of Salmeterol/fluticasone Easyhaler to achieve and maintain asthma or COPD control.
详细描述
A prospective, open-label, non-interventional, multicentre study in adult patients with asthma or COPD who are treated with Salmeterol/fluticasone Easyhaler. During the study the Salmeterol/fluticasone Easyhaler will be used according to the Summary of Product Characteristics. Clinical effectiveness of the treatment will be evaluated with change in asthma or COPD symptoms during 12 weeks treatment.
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
- 否
入选标准
- •Male or female patients with asthma or COPD who have been using salmeterol/fluticasone propionate combination treatment for at least 3 months before the study
- •Age ≥18 years.
- •Written informed consent obtained.
排除标准
- •Pregnant or lactating female patients.
- •Participation in other clinical studies during the study.
- •Known hypersensitivity (allergy) to salmeterol, fluticasone propionate or the excipient lactose
- •Any significant medical disease or condition or other factor that might interfere with study assessments or study participation.
结局指标
主要结局
Asthma Control Test (ACT)
时间窗: 12 weeks
A multiple-choice questionnaire for patients with asthma, each choice is assigned a score 1-5. There are 5 questions to answer. The total score is calculated, ranging between 5 and 25. Lower scores indicate worse asthma control.
COPD Assessment Test (CAT)
时间窗: 12 weeks
A bipolar questionnaire for patients with COPD, there are 8 questions with 2 answers showing different extremes, respondents choose the numbered answer that reflects their opinion (in the range 0-5). The total score is calculated and ranges between 0 and 40. Higher scores indicate worse COPD control.
次要结局
- Feeling of Satisfaction with Inhaler questionnaire (FSI-10)(12 weeks)
- Asthma symptom control assessment(12 weeks)
- Forced expiratory volume in one second (FEV1)(12 weeks)
- A questionnaire to assess Physician's/nurse's perception of Salmeterol/fluticasone Easyhaler overall use(12 weeks)
- Health care utilisation questionnaire(24 weeks)
- Mini-AQLQ questionnaire(12 weeks)
- Forced vital capacity (FVC)(12 weeks)
- Modified Medical Research Council (mMRC) dyspnea questionnaire(12 weeks)
- Symptom burden and exacerbation risk assessment (ABCD classification)(12 weeks)