12-wks Randomised Controlled Trial to Explore the Effect of a Smartphone App. Connected to an Add-on Device System Fitted on pMDI Inhaler on Adherence to Medications Intake and Clinical Outcomes in Difficult-to-treat Asthmatic Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Change from Baseline in adherence rate to entire treatment period
研究概览
简要总结
The purpose of this Study is to assess the effect of a smartphone application connected to an add-on device system fitted on Pressured Metered Dose Inhaler (PMDI) on adherence to take medications as prescribed and clinical outcomes in difficult-to-treat asthmatic patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Patient's written informed consent obtained prior to any study-related procedures
- •Male or female patient aged 18 years and above
- •Patient with established diagnosis of asthma for at least 6 months
- •Patient on maintenance therapy (Fixed dose combination ICS/LABA) with high dose of ICS
- •Patient with ACT score <20 at screening and at randomization
- •Non- or ex-smoker who smoked ≤ 10 Pack-years prior to screening
- •Patient must have their own Android® or iPhone operating system (IOS) smartphone
- •Ability to use the pMDI device correctly
排除标准
- •Patient with an asthma exacerbation or respiratory tract infection requiring systemic steroids and/or antibiotics within 1 to 3 month prior to screening
- •Patient with a history of near-fatal asthma
- •Clinically relevant and uncontrolled cardiac, hepatic, renal, gastrointestinal, endocrine, metabolic, neurologic, psychiatric or any other disorder that would put the safety of the subject at risk through participation, or which would affect the analysis
- •Patient not able to be compliant with the study requirements.
- •Patient with a BMI > 40
- •Patient working on night shifts
- •Patient participating in the clinical phase of an interventional trial or have done so within the last 30 days prior to screening.
- •Patient who has an already planned major surgery or hospitalization
- •Female patient who is pregnant or lactating or who plans to become pregnant in the next 4 months.
- •Patient with a history of hypersensitivity to any of the components of Foster pMDI
研究组 & 干预措施
Reference
Control experience using marketed application to record medication intake without reminders from the app
干预措施: Marketed experience application on adherence (Behavioral)
Intervention
Full experience using marketed application, with all functionalities enabled
干预措施: Marketed experience application on adherence (Behavioral)
结局指标
主要结局
Change from Baseline in adherence rate to entire treatment period
时间窗: From baseline to end of participation (up to 3 months)
Adherence Rate of doses correctly taken twice daily
次要结局
未报告次要终点