A 24-Week Treatment Study to Compare Standard of Care Versus the eMDPI DS in Patients 13 Years or Older With Asthma
Status:
Recruiting
Trial end date:
2022-02-28
Target enrollment:
Participant gender:
Summary
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 patients for all
participants in both groups, to evaluate work productivity and activity impairment in asthma
patients in both groups, to assess the usability and acceptability of the DS by patients in
the DS group and the investigational center personnel, and to evaluate the safety of FS eMDPI
and Albuterol eMDPI.