Description of the Ability to Learn How to Handle Inhaler Devices in Asthma - AUDIT
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Critical errors
研究概览
简要总结
Asthma is a major public health problem. The main treatments against asthma are delivered to the lung through several dry-powder inhaler such as Turbuhaler ®, Diskus® and the new Ellipta® device. In real life, patient's ability to handle a device is not routinely assessed by their practitioner. We hypothesized that many asthmatics cannot properly prepare and prime their device, which may alter the positive effects observed in clinical trials.
详细描述
The main objective of this study is to describe the handling of inhaler devices (Diskus®, Turbuhaler® and Ellipta®) in patients with asthma.
All participants will use each inhaler device (Diskus®, Turbuhaler® and Ellipta®) daily for one week:
- Two puffs per day (Diskus® and Turbuhaler®),
- One puff per day (Ellipta®). At each visit (day 1, 8, 15 and 22), patients will have a physical exam.
For each inhaler device, 4 video recordings will be performed:
- Video recording #1: Inhalation (one puff) without any instruction of use.
- Video recording #2: Inhalation (one puff) after reading the patient information leaflet.
- Video recording #3: Inhalation (one puff) after watching a standardized video demonstrating correct inhaler technique.
- Video recording #4: inhalation (one puff) after seven days of daily use. The patient will be asked to fulfill a satisfaction survey about each inhaler device.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 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
- •Male or female aged more than 18 years
- •Written informed consent
- •Diagnosis of asthma according to international guidelines (GINA 2017)
- •Social security or health insurance
- •Women using an effective method of birth control.
排除标准
- •Previous treatment with Ellipta®, Diskus® or Turbuhaler®
- •Asthma exacerbation within 6 weeks before inclusion
- •Subject having close contacts with devices (Ellipta®, Diskus® or Turbuhaler®) users, currently or in the past
- •Severe asthma
- •Hypersensitivity to budesonide
- •Chronic psychiatric disease
- •Medical condition that may affect handling of inhaler devices
- •Subject deprived of his/her liberty
- •Protected adult
- •Subject in exclusion period related to another protocol
- •Pregnant or breastfeeding women.
研究组 & 干预措施
Group 1
placebo Diskus® placebo Ellipta® Pulmicort® Turbuhaler®
干预措施: placebo Diskus® (Device)
Group 1
placebo Diskus® placebo Ellipta® Pulmicort® Turbuhaler®
干预措施: placebo Ellipta® (Device)
Group 1
placebo Diskus® placebo Ellipta® Pulmicort® Turbuhaler®
干预措施: Pulmicort® Turbuhaler® (Device)
Group 2
placebo Diskus® placebo Ellipta® Pulmicort® Turbuhaler®
干预措施: placebo Diskus® (Device)
Group 2
placebo Diskus® placebo Ellipta® Pulmicort® Turbuhaler®
干预措施: placebo Ellipta® (Device)
Group 2
placebo Diskus® placebo Ellipta® Pulmicort® Turbuhaler®
干预措施: Pulmicort® Turbuhaler® (Device)
Group 3
placebo Diskus® placebo Ellipta® Pulmicort® Turbuhaler®
干预措施: placebo Diskus® (Device)
Group 3
placebo Diskus® placebo Ellipta® Pulmicort® Turbuhaler®
干预措施: placebo Ellipta® (Device)
Group 3
placebo Diskus® placebo Ellipta® Pulmicort® Turbuhaler®
干预措施: Pulmicort® Turbuhaler® (Device)
结局指标
主要结局
Critical errors
时间窗: Day 8 of each treatment
Assessment of the presence of at least a critical error in the use of the inhalation system, from standardized checklist
次要结局
- Patient satisfaction questionnaire(Day 8 of each treatment)
- Non device-dependent errors(Day 8 of each treatment)
- Time for drug administration(Day 8 of each treatment)