CONNected Electronic Inhalers Asthma Control Trial 2 ("CONNECT 2"), a 24-Week Treatment, Multicenter, Open-Label, Randomized, Parallel Group Comparison, Feasibility Study of Standard of Care Treatment Versus the eMDPI Digital System, to Optimize Outcomes in Patients at Least 13 Years of Age or Older With Asthma
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 427
- 试验地点
- 46
- 主要终点
- Number of Participants Achieving Well-Controlled Asthma or Reaching Clinically Important Improvement in Asthma Control
研究概览
简要总结
The primary objective of this study is to demonstrate the effectiveness of the Digital System (DS) in improving asthma control compared to the Standard of Care (SoC) group.
The secondary objective is to describe the asthma management actions by investigational center health care providers (iHCPs) for all participants in both groups, to evaluate short-acting beta2 agonist (SABA) usage and the number of SABA-free days in the DS group, to evaluate adherence patterns to maintenance treatment (FS eMDPI) in the DS group, to assess behavioral correlates of responsiveness to digital health technology among participants for all participants in both groups, to evaluate work productivity and activity impairment in asthma participants in both groups, to assess the usability and acceptability of the DS by participants in the DS group and the investigational center personnel, and to evaluate the safety of FS eMDPI and Albuterol eMDPI.
详细描述
Study duration will be approximately 27 weeks including a one-week screening period, 24 week treatment period, and a 2 week follow-up period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The participant 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.
- •The participant is currently on treatment with a moderate- to high-dose inhaled corticosteroid (ICS) with long-acting beta agonist (LABA).
- •The participant has an Asthma Control Test score of less than 19 at the screening or baseline visit.
- •The participant is willing to discontinue all other maintenance ICS with LABA medications and rescue medications and replace them with the study-provided fluticasone propionate/salmeterol (FS) multidose dry powder inhaler with integrated electronic module (eMDPI) and Albuterol eMDPI, respectively, for the duration of the trial, if randomized to the Digital System group. All other asthma maintenance medications, except for ICS with LABA, may be continued.
- •Additional criteria apply, please contact the investigator for more information.
排除标准
- •The participant is currently being treated prior to enrollment with a digital inhaler system, including the Digihaler system or an external "bolt on" digital system designed to monitor inhaler usage, such as the Propeller Health or Adherium systems.
- •The participant has any clinically significant uncontrolled medical condition (treated or untreated) other than asthma, which in the view of the investigator would preclude participation.
- •The participant was hospitalized for severe asthma in the last 30 days.
- •The participant 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.
- •Additional criteria apply, please contact the investigator for more information.
研究组 & 干预措施
Digital System (DS)
DS group participants utilizing the eMDPI DS, including inhaler, smart device application (App), DHP (Cloud solution), and dashboard
干预措施: Fluticasone propionate/salmeterol (FS) (Drug)
Digital System (DS)
DS group participants utilizing the eMDPI DS, including inhaler, smart device application (App), DHP (Cloud solution), and dashboard
干预措施: Albuterol (Drug)
Standard of Care (SoC) Group
SoC group participants will be treated with their standard of care medications
干预措施: Standard of Care Asthma Medication (Drug)
Standard of Care (SoC) Group
SoC group participants will be treated with their standard of care medications
干预措施: Standard of Care Rescue Medication (Drug)
结局指标
主要结局
Number of Participants Achieving Well-Controlled Asthma or Reaching Clinically Important Improvement in Asthma Control
时间窗: Week 24
A well-controlled asthma was defined as an Asthma Control Test (ACT) score of greater than or equal to 20. Clinically important improvement in asthma control was defined by an increase of at least 3 ACT units from baseline. The ACT was a simple, participant-completed tool used for the assessment of overall asthma control. The ACT included 5 items that assessed daytime and nighttime asthma symptoms, use of reliever medication, and impact of asthma on daily functioning. Each item in the ACT was scored on a 5-point scale ranging from 1 (poor control of asthma) to 5 (well control of asthma), with summation of all items providing scores ranging from 5 to 25. The scores span the continuum of poor control of asthma (score of 5) to complete control of asthma (score of 25), with a cutoff score of 19 and below indicating participants with poorly controlled asthma.
次要结局
- System Usability Scale (SUS) Overall Score for DS Group(Week 24)
- Number of Addition of a Systemic Corticosteroid Medication for Asthma Therapy(Baseline up to Week 24)
- Change From Baseline in the Number of SABA-free Days at Week 24 for the DS Group(Baseline, Week 24)
- Change From Baseline in Beliefs About Medicines Questionnaire (BMQ) Concern Subscale Score at Week 24(Baseline, Week 24)
- Change From Baseline in Work Productivity and Activity Impairment (WPAI) Asthma Questionnaire Score at Week 24(Baseline, Week 24)
- Number of Decreased Doses of Inhaled Medication(Baseline up to Week 24)
- Number of Additional Inhaled Medication(Baseline up to Week 24)
- Frequency of Intervention to Manage Comorbid Conditions Associated With Poor Asthma Control(Baseline up to Week 24)
- Change From Baseline in BMQ Necessity Subscale Score at Week 24(Baseline, Week 24)
- Change From Baseline in BIPQ Cognitive Subscale Score at Week 24(Baseline, Week 24)
- Change From Baseline in BIPQ Emotional Representations Subscale Score at Week 24(Baseline, Week 24)
- Number of Increased Doses of Inhaled Medication(Baseline up to Week 24)
- Change From Baseline in Mean Weekly SABA Usage at Week 24 for the DS Group(Baseline, Week 24)
- Change From Baseline in Brief Illness Perception Questionnaire (BIPQ) Illness Comprehensibility Subscale Score at Week 24(Baseline, Week 24)
- Number of Discussions Between Participant and Investigational Center Healthcare Professional (iHCP) Regarding Inhaler Technique or Adherence(Baseline up to Week 24)
- Number of Changes to Different Inhaled Medication(Baseline up to Week 24)
- Change From Baseline in Adherence to Maintenance Treatment (FS eMDPI) at Week 24 for the DS Group(Baseline, Week 24)
- Number of Participants With Adverse Events (AEs)(Baseline up to Week 26)