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.

Click for participation criteria and map of study locations

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