Multicenter, Open-label, Non-interventional Study (NIS) to Evaluate Patient's Satisfaction and Preference, the Usability of DuoResp® SPIROMAX® and the Impact on Clinical Effects, in the Daily Routine of Asthma and COPD Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 4,034
- 试验地点
- 1
- 主要终点
- Practicability of the device
研究概览
简要总结
The main aim of the study is to investigate patient satisfaction in the treatment of asthma and COPD with the new device of DuoResp® Spiromax® and patient preference. Possible difficulties in the use of the device under real-life conditions in clinical practice are investigated.
详细描述
The study detects the instruction expense in the use of the inhaler, reasons for the choice of the medication, or a switch in treatment of asthma or COPD.
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 and female adult patients with clinical diagnosis of bronchial asthma or chronic obstructive pulmonary disease
- •patients on regular medication with inhaled corticosteroids and long-acting beta-2-agonists in fixed-dose combination
- •patients who recently changed medication to DuoResp® Spiromax or are about to do so
- •capacitated person with present declaration of consent
排除标准
- •diseases contraindicated in accordance with the summary of product characteristic
- •patients who take part in interventional clinical trials parallel or during the last 4 weeks
- •patient shows conditions or diseases that might disturb the monitoring according to the physician
- •patients with substance misuse in their case history (drugs, alcohol) or with other factors (e.g. serious psychiatric conditions) that limit their ability to participate in the study
- •insufficient German language knowledge to understand the patient education and to complete the questionnaires in a correct manner
- •patients involved in the planning and construction of the study (Teva staff and employees of the centres)
- •patient is incapable of giving consent
研究组 & 干预措施
Single group prospective treatment
干预措施: Budesonide, Formoterol Fumarate Dihydrate (Drug)
结局指标
主要结局
Practicability of the device
时间窗: 12 weeks
Investigation of practicability of the device for patients using checklist inhalation errors
Patient Satisfaction and Preference Questionnaire (PASAPQ)
时间窗: 12 weeks
Satisfaction and preference of patients treated with DuoResp® Spiromax® using PASAPQ
次要结局
未报告次要终点