An Open-label Study of Inhaler Device Attributes Investigating Critical and Overall Errors, and Ease of Use and Preference Between a Number of Inhaler Devices (ELLIPTA, DISKUS/ACCUHALER, TURBUHALER, and MDI) in Adult Subjects With Asthma (Study 200330)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 162
- 试验地点
- 5
- 主要终点
- Percentage of subjects making at least one critical error after reading the patient information leaflet
研究概览
简要总结
This study is designed to assess the proportion of asthma subjects making critical and non-critical errors made in using ELLIPTA® inhaler compared with other commercially available inhaler devices such as the TURBUHALER®, MDI (metered-dose inhaler), and DISKUS/ACCUHALER®. This study will also assess the ease of use and preference between the ELLIPTA inhaler and the other commercially available inhaler devices. This is a randomized, open-label, placebo, crossover, multicentre study with a single visit. The study will comprise three sub-studies. Subjects will receive inactive treatment (placebo) via the ELLIPTA inhaler and one of the other inhaler devices depending on the sub-study they are allocated to. Only subjects who are naïve to the ELLIPTA inhaler and to one of the other inhalers that will be used in this study will be included. The study will be conducted in the Netherlands and the UK, and comprises one visit only. A sufficient number of subjects (at least 190) with asthma will be screened and 180 will be randomized to one of the three sub-studies. Eligible subjects will be allocated to one of the sub-studies in the following order depending on their experience of using the other inhaler (i.e., depending on which other inhaler they are naïve to).
ELLIPTA, DISKUS, and ACCUHALER are registered trademarks of the GSK group of companies. TURBUHALER is a registered trademark of AstraZeneca.
详细描述
This is a non-interventional study and not an observational study and therefore some fields are not applicable for the CT.gov observational study design. It would be preferential to have the field populated as "not applicable" for sampling method, time perspective, and observational study model as they don't apply to this study design.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent: Subject must give their signed and dated written informed consent to participate; Subject understands and is willing, able, and likely to comply with study procedures and restrictions; Subject must be able to read, comprehend, and record information in Dutch and/or English
- •Age: >=18 years of age
- •Gender: Male or female subjects.
- •Asthma Diagnosis: A diagnosis of asthma as defined by the National Institutes of Health. Comorbidities (rheumatoid arthritis or other locomotor problems, visual impairment, and depression or anxiety) will be documented as relevant to inhaler use.
- •Asthma treatment: All subjects should be currently receiving treatment for asthma.
- •Must be naive to using ELLIPTA inhaler and at least one other inhaler device.
排除标准
- •Chronic Obstructive Pulmonary Disease (COPD): Subjects with a current diagnosis of COPD only.
- •Contraindications: A history of allergy or hypersensitivity to lactose/milk protein or magnesium stearate or to any other excipient.
- •Subjects who are currently participating in another randomised pharmacological interventional trial.
- •Inability to Read: In the opinion of the investigator, any subject who is unable to read and/or would not be able to complete a questionnaire and understand verbal instructions
结局指标
主要结局
Percentage of subjects making at least one critical error after reading the patient information leaflet
时间窗: Day 1
In each sub-study, subjects will be asked to read the patient instruction leaflet of the first device and then asked to demonstrate inhaler use. Any errors (critical or non-critical) made by the subject while using the first inhaler will be recorded by the health care professional (HCP). The same procedures will be followed for the second inhaler. A critical error is defined as an error that is most likely to result in no or only minimal medication being inhaled
次要结局
- The number of instructions (maximum three times) from the HCP which are needed to demonstrate adequate inhalation technique(Day 1)
- The percentage of subjects making at least one overall error after the first instruction on use by the HCP(Day 1)
- Percentage of subjects making at least one overall error after reading the patient information leaflet(Day 1)
- Percentage of subjects making at least one critical error after the first instruction from HCP(Day 1)
- The percentage of subjects who prefer the ELLIPTA device compared to the other devices as assessed by the 'preference' questionnaire(Day 1)
- The percentage of subjects who found the ELLIPTA device 'easy to use' compared with the other devices' as assessed by the 'ease of use' questionnaire(Day 1)