Study Evaluating Preference, Satisfaction and Ease of Use of Genuair® (Pressair™) and Breezhaler® (Neohaler™) Inhalers in Chronic Obstructive Pulmonary Disease (COPD) Diagnosed Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 128
- 试验地点
- 6
- 主要终点
- Percentage of patients who prefer Genuair® (Pressair™) versus Breezhaler® (Neohaler™) at Visit 2
研究概览
简要总结
Preference study: Genuair® (Pressair™) vs Breezhaler® (Neohaler™) inhalers in patients with COPD
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult male or female patients aged ≥40 years with stable moderate-to-severe COPD according to the GOLD Guidelines classification (grades II and III): forced expiratory volume in 1 second (measured between 10 to 15 minutes post-inhalation of 400 μg of salbutamol) is 30%≤FEV1<80% of the predicted normal value
- •Patients naïve to both study inhaler devices, Genuair® and Breezhaler®, for at least 2 years
- •Agreement to participate and voluntarily sign the informed consent form
排除标准
- •Patients with other clinically significant uncontrolled chronic diseases, particularly body malformations or diseases affecting coordination and/or motor system
- •Patients unable to read product package instructions and answer patient reported questionnaires (PASAPQ)
- •Patients with any other serious or uncontrolled mental health problems
- •Patients currently participating in other randomised clinical studies
- •Patients with COPD exacerbation within 6 weeks before Visit 1 and patient hospitalised for COPD exacerbation within 3 months prior to Visit 1
- •Patients with any other conditions that, in the investigator's opinion, might indicate the patient to be inappropriate for the study
- •Patient likely to be uncooperative
研究组 & 干预措施
Group A
Genuair® (Pressair™) first; Breezhaler® (Neohaler™) second
干预措施: Genuair® (Device)
Group A
Genuair® (Pressair™) first; Breezhaler® (Neohaler™) second
干预措施: Breezhaler® (Device)
Group B
Breezhaler® (Neohaler™) first; Genuair® (Pressair™) second
干预措施: Genuair® (Device)
Group B
Breezhaler® (Neohaler™) first; Genuair® (Pressair™) second
干预措施: Breezhaler® (Device)
结局指标
主要结局
Percentage of patients who prefer Genuair® (Pressair™) versus Breezhaler® (Neohaler™) at Visit 2
时间窗: 14 Days
Patients will be asked to answer which device they prefer after 2 weeks of daily practice recorded via PASAPQ (Patient Satisfaction and Preference Questionnaire) a self-administered, 15-item measure of respiratory inhalation device satisfaction and preference. The PASAPQ 15-item instrument includes 13 satisfaction items \[using a Likert-type scale from 1 (very dissatisfied) to 7 (very satisfied)\], a preference item, and a question on willingness to continue using the device.
次要结局
- Mean for the overall satisfaction score with Genuair® (Pressair™) and Breezhaler® (Neohaler™) at Visit 2(14 Days)
- Percentage of patients making at least 1 critical error with Genuair® (Pressair™) and Breezhaler® (Neohaler™) at Visit 2(14 Days)