Effect of the Use of an add-on Device Connected to a Smartphone App on Difficult-to-treat Asthmatic Patient's Adherence (ADVICE)
2021年6月28日 更新者:Chiesi Farmaceutici S.p.A.
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
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.
研究概览
研究类型
介入性
注册 (实际的)
160
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
-
-
-
Manchester、英国、M20 2RN
- Barlow Medical Centre
-
-
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:支持治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:四人间
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
其他:Reference
Control experience using marketed application to record medication intake without reminders from the app
|
To evaluate the effect of electronic capture of medication intake through a smartphone app on treatment's adherence
|
实验性的:Intervention
Full experience using marketed application, with all functionalities enabled
|
To evaluate the effect of electronic capture of medication intake through a smartphone app on treatment's adherence
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Change from Baseline in adherence rate to entire treatment period
大体时间:From baseline to end of participation (up to 3 months)
|
Adherence Rate of doses correctly taken twice daily
|
From baseline to end of participation (up to 3 months)
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Asthma Control Test score
大体时间:From baseline to end of participation (up to 3 months)
|
Change from Baseline
|
From baseline to end of participation (up to 3 months)
|
Test of the Adherence to Inhalers score
大体时间:From baseline to end of participation (up to 3 months)
|
Change from Baseline
|
From baseline to end of participation (up to 3 months)
|
Percentage of days without intake of rescue medication
大体时间:From baseline to end of participation (up to 3 months)
|
Change from Baseline
|
From baseline to end of participation (up to 3 months)
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Annaliese Linnhoff、Research Center for Medical Studies Praxis für Lungen- und Bronchialheilkunde
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2019年8月12日
初级完成 (实际的)
2020年7月6日
研究完成 (实际的)
2020年7月6日
研究注册日期
首次提交
2019年5月14日
首先提交符合 QC 标准的
2019年5月14日
首次发布 (实际的)
2019年5月15日
研究记录更新
最后更新发布 (实际的)
2021年7月1日
上次提交的符合 QC 标准的更新
2021年6月28日
最后验证
2021年6月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.