CONNected Electronic Inhalers Asthma Control Trial 1 ("CONNECT 1"), a 12-Week Treatment, Multicenter, Open-Label, Randomized, Parallel Group Comparison, Feasibility Study to Evaluate the Effectiveness of the Albuterol 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
- 333
- 试验地点
- 30
- 主要终点
- Percentage of Participants Achieving Meaningful Asthma Improvement at the End of 12-Week Treatment Period
研究概览
简要总结
This is a 12-week treatment, multicenter, open-label, randomized, parallel group comparison feasibility study to evaluate the effectiveness of the Albuterol eMDPI Digital System (DS), including inhaler, App, digital health platform (DHP) (Cloud solution), and dashboard, to optimize outcomes in participants at least 13 years of age or older with asthma.
The study will consist of a screening visit, a 12-week open-label treatment period, and a follow-up telephone call (2 weeks following treatment completion).
Participants with suboptimal asthma control will be enrolled in the study and randomized in a 1:1 ratio to 1 of 2 parallel groups stratified by investigational center: DS group participants utilizing the Albuterol eMDPI DS, including inhaler, App, DHP (Cloud solution), and dashboard, and CC group participants who will be treated with their standard of care albuterol-administering rescue inhalers and will not use the DS during the treatment 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
- •The participant is currently on treatment with an inhaled corticosteroid (ICS) with a long-acting beta2 antagonist (LABA).
- •The participant is currently using inhaled albuterol sulfate as rescue medication and is willing to discontinue all other rescue medications and replace them with the study provided Albuterol eMDPI.
- •The participant can read and communicate in English and is familiar with and is willing to use his/her own smart device and download and use the App.
- •Additional criteria apply, please contact the investigator for more information
排除标准
- •The participant has any clinically significant uncontrolled medical condition (treated or untreated) other than asthma.
- •The participant was hospitalized for severe asthma in the last 30 days.
- •The participant has a diagnosis of Chronic Obstructive Pulmonary Disease (COPD) or Asthma-COPD Overlap (ACO).
- •The participant is a current smoker or has a greater than 10 pack-year history of smoking.
- •The participant is currently being treated with systemic corticosteroids (oral, intramuscular, or intravenous) or has been treated within the last 30 days.
- •The participant has any treatment with biologics for asthma (for example, omalizumab, anti-IL5, anti-IL5R, anti-IL4R), or has had such treatment within the last 90 days.
- •Additional criteria apply, please contact the investigator for more information
研究组 & 干预措施
Digital System (DS)
Participants will be trained on the use of the albuterol eMDPI DS (including instructions on how to use both the eMDPI and the App) and, upon demonstrating competency, will receive 2 albuterol eMDPI devices for use as reliever bronchodilators to replace their reliever treatment during the study. The eMDPI Digital System consists of 4 devices: Device 1: albuterol eMDPI (the test investigational medicinal product [IMP]); Device 2: Patient-facing App; Device 3: Digital health platform (DHP) (Cloud solution); and Device 4: Provider-facing Dashboard. Participants will receive 90 micrograms (mcg) albuterol, 1 to 2 oral inhalations every 4 to 6 hours, as needed for 12 weeks.
干预措施: Albuterol eMDPI DS (Drug)
Concurrent Control (CC)
Participants will be treated with their standard of care albuterol-administering reliever inhalers and will use the digital system during the treatment period. Participants will be reimbursed or given a voucher to use to purchase their existing reliever medications.
干预措施: albuterol (Drug)
结局指标
主要结局
Percentage of Participants Achieving Meaningful Asthma Improvement at the End of 12-Week Treatment Period
时间窗: Baseline to Week 12
Meaningful asthma improvement was defined as an Asthma Control Test (ACT) score of at least 20 at the end of the 12-week treatment period or an increase of at least 3 units on the ACT score from baseline at the end of the 12-week treatment period. The ACT was a simple, participant-completed tool used to assess overall asthma control. The 5 items included in the ACT assess daytime and night-time 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, with a 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
- Change From Baseline in Mean Weekly Short-acting Beta2 Agonist (SABA) Usage at Week 12 for the DS Group(Baseline, Week 12)
- Change From Baseline in the Number of SABA-free Days at Week 12 for the DS Group(Baseline, Week 12)
- Number of Discussions Between Participant and Investigational Center Healthcare Professional (iHCP) Regarding Inhaler Technique or Adherence(Baseline up to Week 12)
- Number of Decreased Doses of Inhaled Medication(Baseline up to Week 12)
- Number of Increased Doses of Inhaled Medication(Baseline up to Week 12)
- Number of Changes to Different Inhaled Medication(Baseline up to Week 12)
- Number of Additional Inhaled Medication(Baseline up to Week 12)
- Number of Addition of a Systemic Corticosteroid Medication for Asthma Therapy(Baseline up to Week 12)
- Frequency of Intervention to Manage Comorbid Conditions Associated With Poor Asthma Control(Baseline up to Week 12)
- System Usability Scale (SUS) Overall Score(Week 12)
- Change From Baseline in BMQ Necessity Subscale Score at Week 12(Baseline, Week 12)
- Change From Baseline in BIPQ Emotional Representations Subscale Score at Week 12(Baseline, Week 12)
- Change From Baseline in Beliefs About Medicines Questionnaire (BMQ) Concern Subscale Score at Week 12(Baseline, Week 12)
- Change From Baseline in Brief Illness Perception Questionnaire (BIPQ) Illness Comprehensibility Subscale Score at Week 12(Baseline, Week 12)
- Change From Baseline in BIPQ Cognitive Subscale Score at Week 12(Baseline, Week 12)
- Number of Participants With Adverse Events (AEs)(Baseline up to Week 14)