NL-OMON53851撤回4 期
CONNected Electronic Inhalers Asthma Control Trial 3 (*CONNECT 3*), a 24-Week Treatment, Multicenter, Open Label, Randomized, Parallel Group Comparison Study of Standard of Care Treatment Versus the Budesonide/Formoterol Digihaler Digital System, to Optimize Outcomes in Adult Patients with Asthma - CONNECT 3
PRA Group BV0 个研究点目标入组 95 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- 入组人数
- 95
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Inclusion Criteria: Patients may be included in the study only if they meet all
- •of the following criteria:
- •a. The patient is 18 years or older at the time of screening.
- •b. The patient has a documented diagnosis of asthma established at the
- •investigational center at the time of informed consent or the investigator
- •confirms a diagnosis of asthma.
- •c. The patient is currently on treatment with a moderate- to high-dose ICS with
- •d. The patient has an ACT score of less than 19 at the screening/baseline visit.
- •e. The patient is willing to discontinue all other maintenance ICS with LABA
- •medications and rescue medications and replace them with the study-provided BF
- •Digihaler as MART for the duration of the trial, if randomized to the BF
- •Digihaler DS group. All other asthma maintenance medications, except for ICS
- •with LABA, may be continued.
- •f. The patient can read fluently and communicate in United Kingdom English,
- •Dutch, or German, as applicable, and is familiar with and is willing to use
- •his/her own mobile phone that meets the minimum App requirements and download
- •and use the App.
- •g. The patient is able to provide written informed consent.
- •h. The patient must be willing and able to comply with study requirements and
- •restrictions and to remain at the investigational center for the required
- •duration during the study period, and willing to return to the investigational
- •center for the follow up procedures and assessments as specified in this
排除标准
- •Exclusion Criteria: Patients will be excluded from participating in this study
- •if they meet any of the following criteria:
- •a. The patient has any clinically significant uncontrolled medical condition
- •(treated or untreated) other than asthma, which in the view of the investigator
- •would preclude participation.
- •b. The patient has any medical or psychiatric condition that, in the opinion of
- •the investigator, could jeopardize or would compromise the patient*s ability to
- •participate in this study.
- •c. The patient is currently using or has used, in the 12 months prior to
- •enrollment, a digital inhaler system designed to monitor inhaler usage such as,
- •but not limited to, the Propeller Health, Adherium, or Amiko systems.
- •d. The patient has a diagnosis of chronic obstructive pulmonary disease (COPD)
- •or asthma-COPD overlap (ACO).
- •e. The patient is a current smoker or has a greater than 10 pack-year history
- •of smoking.
- •f. The patient was treated for asthma exacerbation, including hospitalization
- •or emergency visits, in the last 30 days.
- •g. The patient is currently being treated with systemic corticosteroids (oral,
- •intramuscular, or intravenous) or has been treated within the last 30 days.
- •h. The patient has any treatment with biologics for asthma (eg, omalizumab,
- •anti interleukin (IL)5, anti-IL5R, anti-IL4R), or has had such treatment within
- •the last 90 days.
- •i. The patient has a known hypersensitivity to any components of the IMPs
- •stated in this protocol.
研究者
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