EUCTR2019-003082-17-DE进行中（未招募）1 期
EFFECT OF ELECTRONIC MONITORING AND FEEDBACK ON ADHERENCE TO EASYHALER CONTROLLER MEDICATION IN PATIENTS WITH ASTHMA - eMOFEE
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
- 166
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Written informed consent obtained.
- •2. Male and female subjects with documented diagnosis of asthma.
- •3. Age 18 to 65 years, inclusive.
- •4. ACT score 19 or less at screening (visit 1).
- •5. Subject must have been using budesonide, budesonide/formoterol combination or salmeterol/fluticasone propionate combination as his/her controller medication at constant dose for at least 3 months prior to screening and be able to switch to use the same active substance(s) via Easyhaler. Subjects already using budesonide, budesonide/formoterol combination or salmeterol/fluticasone propionate combination Easyhaler are also eligible.
- •6. Subject must be able to switch his/her rescue medication to salbutamol Easyhaler for the duration of the study.
- •7. A course of oral corticosteroid for asthma exacerbation in the previous year, or a history of a hospitalisation or emergency department visit with an asthma exacerbation in the last year.
- •8. Subject must be able to speak and read German.
- •9. Subject must have their own Android (version 5.0 or later) or iPhone operating system (IOS, version 11.0 or later) smart phone and a data package suitable for the installation and running of the mobile application and sending and receiving data.
- •10. Subject must be willing and able to accept Propeller Health’s User Agreement and Privacy and Cookies Policy, download the mobile application on their smartphone, and keep Wi Fi/mobile data, Bluetooth, and the mobile application on for the duration of the study.
- •11. Subject must be willing to share details of their e-mail address and phone number with Propeller Health to enable log-in and various alerts.
- •For randomisation:
- •1. Subject is capable and willing to use the Easyhaler as demonstrated during the run-in period.
- •2. Subject is capable and willing to use the sensor and the mobile application as demonstrated during the run-in period.
- •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 166
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Change of asthma controller medication during the last 3 months before visit 1 or during the run-in period.
- •2. Asthma exacerbation requiring a course of systemic (e.g. oral) corticosteroid, hospitalisation or emergency department visit within 1 month before visit 1 or during the run-in period.3. Concomitant major respiratory disease (e.g. COPD) which, in the opinion of the investigator, may complicate the measurement of asthma control.
- •4. Smokers or ex-smokers with > 20 pack-year history of smoking.
- •5. An acute upper or lower respiratory tract infection within 14 days before visit 1 or visit 2.
- •6. Subjects who are receiving or have received an investigational drug within 30 days before visit 1, or within 5 half-lives (whichever is longer), or who are participating or have participated in a study using connected inhalers.
- •7. Any significant medical disease or condition or other factor that, in the investigator’s opinion, might interfere with study assessments or study participation.
- •8. A family member living in the same household already enrolled in the study.
- •9. Pregnant (positive pregnancy test at screening) or lactating female subjects.
- •10. Women of childbearing potential (WOCBP) not using an acceptable contraception.
- •11. Subject is in a dependent relationship with the investigator/study site/sponsor of the clinical study.
- •12. Subjects who have been institutionalised as a result of an administrative or court order.
- •12.13. Subject has an active COVID-19 infection, i.e. currently has COVID-19 symptoms or has a current positive COVID-19 test.
研究者
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