Digital Adherence Monitoring of Inhalative Therapy in Real- Life Conditions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 434
- 试验地点
- 1
- 主要终点
- Change in asthma control test (ACT) score
研究概览
简要总结
This study is designed as a multicenter, observational, non-interventional, open label, 26-week study in order to observe how asthma control changes under treatment with Mometasone Fuorat/Indacaterol/ Glycopyrronium (MF/IND/GLY) Breezhaler® sensor system or under treatment with fixed-dose combination (FDC) triple therapy after 26 weeks of treatment.
详细描述
Subjects in one group will receive MF/IND/GLY together with the Propeller add-on sensor for the Breezhaler® and access to the smartphone app according to label. Subjects in the other group will receive any triple FDC according to label. The physician's decision to initiate or switch a patient to MF/IND/GLY Breezhaler® system or any other triple FDC must have been taken prior to and independently from the decision to include the patient in the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •To participate in the study, all of the following inclusion criteria must be met:
- •Patients (m/f/d) at the age of ≥18
- •Written declaration of consent
- •Asthma diagnosis according to German Asthma Guideline NVL, 4th edition
- •Suitability for a therapy with MF/IND/GLY in combination with the sensor system or another ICS+LABA+LAMA FDC according to SPC
- •At least 6 months of inhaled therapy with ICS+LABA (high dose) or ICS+LABA+LAMA (medium or high dose) before switching or escalating asthma medication at baseline
- •Change or escalation of the asthma medication to MF/IND/GLY in combination with the sensor system or another ICS+LABA+LAMA FDC according to the therapy decision of the treating physician
- •Availability of at least one ACT value of the last 6 months before consent
- •Cohort treated with MF/IND/GLY in combination with the sensor system
- •Owning an Android or iOS smartphone or tablet on which the app can be installed (via WiFi or mobile data network) and run (requires about 75 megabytes of storage space) and which is capable of establishing a Bluetooth connection to the sensor The patient must agree to activate the app, the Bluetooth connection and the mobile data connection regularly (at least once a month).
- •Availability of an e-mail address
排除标准
- •To participate in the study, none of the following exclusion criteria must apply:
- •Use of a digital inhaler-coupled inhalation tracking system to support adherence in the last 3 months prior to study entry
- •Simultaneous participation in an interventional study or in another Novartis-sponsored noninterventional study
- •Asthma therapy with a biological agent, if not stable at the same dosage for at least 3 months
研究组 & 干预措施
MF/IND/GLY Breezhaler® plus Propeller Health
patients receiving MF/IND/GLY Breezhaler® plus electronic inhalation tracking sensor (Propeller Health) according to label
干预措施: MF/IND/GLY plus sensor system (Combination Product)
Other FDC therapy
patients receiving ICS+LABA+LAMA FDC therapy according to label
干预措施: FDC therapy (Drug)
结局指标
主要结局
Change in asthma control test (ACT) score
时间窗: Baseline, week 26
ACT assesses the frequency of shortness of breath and general asthma symptoms, use of rescue medications, the effect of asthma on daily functioning, and overall self-assessment of asthma control. It is a self-administered questionnaire comprising five items that are assessed on a five point categorical scale (1 to 5) and the scores are summed to give a total score ranging from 5 to 25, with a score of \>=20 denoting 'controlled asthma', a score of 16-19 denoting 'partially controlled asthma', and a score of \<=15 denoting 'uncontrolled asthma'. The total score is calculated as the sum of the scores from all 5 questions. Higher scores indicates improved asthma control.
次要结局
- Description of reasons for prescribing MF/IND/GLY plus sensor or triple FDC as indicated by the physician(Baseline)
- Percentage of patients showing an improvement in self-reported test adherence to inhalers (TAI) questionnaire(26 weeks)
- Percentage of patients achieving the minimal clinically important difference (MCID) change(Baseline, week 26)
- Percentage of patients with an ACT score <19(26 weeks)
- Course of adherence in the subgroup receiving MF/IND/GLY plus sensor(26 weeks)
- Percentage of days with adherence to treatment in the subgroup receiving MF/IND/GLY plus sensor(26 weeks)
- Description of of patient characteristics at baseline(Baseline)
- Change in Post-dose trough Forced Expiratory Volume in one second (FEV1)(Baseline, week 26)
- Change in Forced vital capacity (FVC)(Baseline, week 26)
- Adverse events(26 weeks)