Effectiveness of Albuterol Inhaler With Integrated Electronic Module Digital System

Study Title
A 12-Week Treatment Study to Evaluate the Effectiveness of Albuterol Multidose Dry Powder Inhaler With Integrated Electronic Module Digital System (eMDPI DS) in Patients 13 Years or Older With Asthma
Teva Identifier
ABS-AS-40138
ClinicalTrials.gov Identifier
NCT03890666
Study Status
Completed
Trial Condition(s)
Asthma
Interventions
Drug: Albuterol eMDPI DS | Drug: albuterol

Study Description

This is a 12-week treatment, multicenter, open-label, randomized, parFemale, Maleel group comparison feasibility study to evaluate the effectiveness of the Albuterol eMDPI Digital System (DS), including inhaler, App, DHP (Cloud solution), and dashboard, to optimize outcomes in patients 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 cFemale, Male (2 weeks following treatment completion).

Patients with suboptimal asthma control will be enrolled in the study and randomized in a 1:1 ratio to 1 of 2 parFemale, Maleel groups stratified by investigational center: DS group patients utilizing the Albuterol eMDPI DS, including inhaler, App, DHP (Cloud solution), and dashboard, and CC group patients who will be treated with their standard of care albuterol-administering rescue inhalers and will not use the DS during the treatment period.

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Key Participation Requirements

Gender
Female, Male
Age Range
13 Years and older
Trial Duration
October 26, 2020 - October 4, 2021
Phase
Phase 4

Additional info

Study Type

Interventional