Usability of Levodopa Cyclops™ Compared to INBRIJA® During an Off Episode in Parkinson's Disease Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Correct performance of inhalation maneuvers
研究概览
简要总结
Currently there is one Levodopa inhaler on the market, the INBRIJA® inhaler. When looking at the user instructions for the INBRIJA®, multiple steps are necessary including preparing and cleaning the inhaler. The Levodopa Cyclops™ inhaler also requires steps to be ready-for-use, however there are less steps required to reach this 'ready-for-use' state. This is mainly because the medicine (Levodopa) is already prefilled in the inhaler. Moreover, the Levodopa Cyclops™ is a single-use inhaler and cleaning steps are not necessary. Since both inhalers should be used during off episodes, there might be a preference for one inhaler over the other due to the instructions. An off episode might impair the ability and length to successfully operate an inhaler due to mental or mobility issues. This study investigates if Parkinson patients have a preference for one of the inhalers based on handling steps, ease-of-use, understandability.
详细描述
Sixteen Parkinson's patients, who are ≥ 18 years of age, regularly suffering from predictable off episodes, able to understand the inhaler user instructions (no cognitive dysfunction) and who did not previously participate in the Parkinson DPI-1,2,3,4 or 5 study or in a study using INBRIJA®.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •Diagnosed with Parkinson's disease by a neurologist;
- •At least 18 years of age;
- •Regularly suffering from predictable off episodes despite medication;
- •Recognizable off episodes for themselves and others;
- •Signed informed consent
排除标准
- •Not able to understand an inhalation instruction of either the Levodopa Cyclops™ or the INBRIJA® (within a maximum of 20 minutes of explanation per inhaler);
- •Cognitive dysfunction, which precludes good understanding of instructions and/or informed consent;
- •Previously participated in the Parkinson DPI-1, DPI-2, DPI-3, DPI-4 or DPI-5 study (prior knowledge of the inhalation maneuver of the Levodopa Cyclops™)
- •Having experience with using the INBRIJA® inhaler.
结局指标
主要结局
Correct performance of inhalation maneuvers
时间窗: 15 minutes for performing the inhalation maneuvers with both the placebo inhalers (Inbrija and Cyclops) during a Parkinson's off episode
The main study parameter is to investigate whether Parkinson's patients perform the correct steps in accordance with the instruction card of respectively the Levodopa Cyclops™ or INBRIJA® inhaler after the primary inhalation instructions.
次要结局
- Inhaler preference of Parkinson patients(10 minutes for filling in the questionnaire during or directly after a Parkinson's off episode)