Study to Compare Standard of Care Versus the eMDPI DS in Participants 13 Years or Older With Asthma

Study Title

A 24-Week Treatment Study to Compare Standard of Care Versus the eMDPI DS in Patients 13 Years or Older With Asthma

Teva Identifier

FSS-AS-40139

ClinicalTrials.gov Identifier

NCT04677959

Study Status

Completed

Trial Condition(s)

Asthma

Interventions

Drug: Fluticasone propionate/salmeterol (FS) | Drug: Albuterol | Drug: Standard of Care Asthma Medication | Drug: Standard of Care Rescue Medication

Study Description

The primary objective of this study is to demonstrate the effectiveness of the Digital System (DS) 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 Female, Male 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 Female, Male 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.

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Key Participation Requirements

Gender

Female, Male

Age Range

13 Years and older

Trial Duration

February 16, 2021 - March 4, 2022

Phase

Phase 4

Additional info

Study Type

Interventional