Acceptability and Usability of the A202 Spacer Device as an add on with pressurized Metered Dose Inhaler (pMDI) in Patients with Asthma and COPD
试验速览
- 阶段
- Phase 3 4
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Patient comfort in using the device will be assessed based on responses to a structured questionnaire
研究概览
简要总结
This trial aims to study the acceptability, usability and compliance to inhaled medication with a spacer pre-attached to the standard-of-care metered dose inhaler device in participants with asthma and COPD. Spacers are standard add-ons to metered dose inhalers and have been proven to enhance drug delivery, but are bulky to carry around and hence lack portability.
The novel spacer device to be used in the present study is compact and can be kept attached to the metered dose inhaler due to its smaller form factor and due to the fact that it can be left attached due to it’s hinge-like attachment feature, which makes it portable. Participants will receive standard doses of inhaled medication, but will be able to carry around their inhalers with the spacer attached, which improves drug delivery.
The study aims to study the acceptability of this attached spacer as well as compliance to inhaled therapy with the added device over a 8-week period
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •For Asthma Adults aged 18 to 65 years For COPD 40 to 65 years age Participants willing to participate in the study Participants who are already using metered dose inhaler with spacer brands available in the market.
排除标准
- •Pregnant women and breastfeeding mothers Patients admitted with acute exacerbation of asthma or COPD Patients who are on nebulized medications Participants who have psychiatric illness or any other severe comorbid illness which may preclude participation in study Participants with an underlying end stage lung disease.
结局指标
主要结局
Patient comfort in using the device will be assessed based on responses to a structured questionnaire
时间窗: Patient comfort in using the device will be assessed fortnightly at 2nd, 4th, 6th and 8th week.
次要结局
- Compliance to metered dose inhaler with attached spacer(Week 2 week 4 week 6 week 8)
研究者
Dr Uma Maheswari K
St Johns Medical College