Digital albuterol system feasibility studied in 333 asthma patients with suboptimal control
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Key Takeaway
Note: This feasibility study of a digital albuterol system did not report efficacy results.
This was a phase 4, randomized, open-label, multicenter feasibility study involving 333 participants aged 13 years or older with asthma and suboptimal asthma control. The intervention group used the Albuterol eMDPI Digital System, which includes an inhaler, app, digital health platform, and dashboard. The comparator group received standard of care albuterol rescue inhalers. The primary outcome was the percentage of participants achieving meaningful asthma improvement at the end of the 12-week treatment period, followed by a 2-week telephone follow-up. The study text does not report any results for this primary efficacy endpoint, including percentages, effect sizes, or statistical significance. No safety or tolerability data on adverse events, serious adverse events, or discontinuations were provided. The study was funded by Teva Branded Pharmaceutical Products R&D, Inc. Key limitations include the open-label design, which may introduce bias, and the fact it is a feasibility study not powered to demonstrate efficacy. The lack of reported results for the primary outcome significantly limits any clinical interpretation. In practice, this study represents an early investigation into a digital health system for asthma rescue medication; clinicians should await published efficacy and safety results before considering any implications for patient care.
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View Original Abstract ↓
Status: COMPLETED | Phase: PHASE4
Condition(s): Asthma
Intervention(s): Albuterol eMDPI DS (DRUG), albuterol (DRUG)
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.
Primary Outcome(s): Percentage of Participants Achieving Meaningful Asthma Improvement at the End of 12-Week Treatment Period
Enrollment: 333 (ACTUAL)
Lead Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Start: 2020-10-26 | Primary Completion: 2021-10-04
Results posted: 2022-10-27
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