EUCTR2021-003951-41-NL进行中（未招募）1 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
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 500
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
- 性别
- All
入选标准
- •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 LABA.
- •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 protocol.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 250
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 250
排除标准
- •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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