Background

The albuterol Digihaler (albuterol 90 μg/dose) transmits data wirelessly to a smart device application, which synchronizes with a Digital Health Platform to store and transfer data to a web-based Dashboard. The Reliever Digihaler System (RDS) comprises the albuterol Digihaler, application, Digital Health Platform and Dashboard. This allows patients and health care professionals to review reliever inhaler usage and inhalation quality to aid clinical decision making.

Objective

To demonstrate the effectiveness, as measured by change in asthma control, of the RDS compared with standard of care.

Methods

In this 12-week study, participants aged 13 years or older with suboptimal asthma control (Asthma Control Test [ACT] score < 19) were randomized to use either RDS or standard of care albuterol reliever inhalers. The health care professionals were recommended at study start to check each participant’s inhalation data (including inhalation quantity and quality parameters) 1 or more times per week. Primary outcome was the proportion of participants achieving clinically meaningful improvement in asthma control (ACT score ≥ 20 at week 12 and/or increase ≥ 3 units from baseline). Bayesian statistical analysis provided a posterior probability distribution for odds ratios with corresponding credible intervals.

Results

Participants using the RDS (n = 167) had an 85.3% probability of greater odds of clinically meaningful asthma control improvements than those using SoC (n = 166) after 3 months (mean odds ratio 1.33; 95% credible interval 0.813–2.050).

Conclusions

In this study, participants using the RDS had greater odds of clinically meaningful improvements in asthma control versus SoC after 3 months. Further investigation of the potential of the RDS to help improve asthma management is warranted.

中文翻译：

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数字吸入器系统对哮喘患者的有效性：一项为期 12 周的开放标签随机研究 (CONNECT1)

背景

albuterol Digihaler（albuterol 90 μg/剂量）将数据无线传输到智能设备应用程序，该应用程序与数字健康平台同步以存储数据并将数据传输到基于网络的仪表板。Reliver Digihaler System (RDS) 包括沙丁胺醇 Digihaler、应用程序、数字健康平台和仪表板。这使患者和医疗保健专业人员能够审查缓解吸入器的使用情况和吸入质量，以帮助做出临床决策。

客观的

与护理标准相比，通过哮喘控制的变化来证明 RDS 的有效性。

方法

在这项为期 12 周的研究中，年龄在 13 岁或以上且哮喘控制不佳（哮喘控制测试 [ACT] 评分 < 19）的参与者被随机分配使用 RDS 或标准护理沙丁胺醇缓解吸入器。建议医护人员在研究开始时每周检查每个参与者的吸入数据（包括吸入量和质量参数）1 次或更多次。主要结果是参与者在哮喘控制方面取得有临床意义改善的比例（第 12 周 ACT 评分≥20 和/或从基线增加≥3 个单位）。贝叶斯统计分析提供了具有相应可信区间的比值比的后验概率分布。

结果

与使用 SoC 的参与者 (n = 166) 相比，使用 RDS (n = 167) 的参与者在 3 个月后有 85.3% 的概率获得具有临床意义的哮喘控制改善（平均优势比 1.33；95% 可信区间 0.813–2.050）。

结论

在这项研究中，与 SoC 相比，使用 RDS 的参与者在 3 个月后在哮喘控制方面有更大的临床意义改善。有必要进一步研究 RDS 帮助改善哮喘管理的潜力。