A 12-Week Treatment Study to Evaluate the Effectiveness of Albuterol Multidose Dry Powder Inhaler With Integrated Electronic Module Digital System (eMDPI DS) in Participants13 Years or Older With Asthma

Completed · Phase 4

Conditions studied: Asthma

In brief

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.

Key facts

Study ID

NCT03890666

Run by

Teva Branded Pharmaceutical Products R&D, Inc.

People needed

333

Starts

2020-10-26

Expected to finish

2021-10-04

Last updated by the study team

2026-03-19

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The participant has a documented diagnosis of asthma
• The participant is currently on treatment with an inhaled corticosteroid (ICS) with a long-acting beta2 antagonist (LABA).
• The participant is currently using inhaled albuterol sulfate as rescue medication and is willing to discontinue all other rescue medications and replace them with the study provided Albuterol eMDPI.
• The participant can read and communicate in English and is familiar with and is willing to use his/her own smart device and download and use the App.
• Additional criteria apply, please contact the investigator for more information

You may not qualify if…

• The participant has any clinically significant uncontrolled medical condition (treated or untreated) other than asthma.
• The participant was hospitalized for severe asthma in the last 30 days.
• The participant has a diagnosis of Chronic Obstructive Pulmonary Disease (COPD) or Asthma-COPD Overlap (ACO).
• The participant is a current smoker or has a greater than 10 pack-year history of smoking.
• The participant is currently being treated with systemic corticosteroids (oral, intramuscular, or intravenous) or has been treated within the last 30 days.
• The participant has any treatment with biologics for asthma (for example, omalizumab, anti-IL5, anti-IL5R, anti-IL4R), or has had such treatment within the last 90 days.
• Additional criteria apply, please contact the investigator for more information

Where it is running

• Teva Investigational Site 14232 — Birmingham, Alabama, United States
• Teva Investigational Site 14302 — Los Angeles, California, United States
• Teva Investigational Site 14301 — Stockton, California, United States
• Teva Investigational Site 14236 — Colorado Springs, Colorado, United States
• Teva Investigational Site 14198 — Denver, Colorado, United States
• Teva Investigational Site 14220 — New Haven, Connecticut, United States
• Teva Investigational Site 14197 — Aventura, Florida, United States
• Teva Investigational Site 14306 — Miami, Florida, United States
• Teva Investigational Site 14215 — Sarasota, Florida, United States
• Teva Investigational Site 14304 — Albany, Georgia, United States
• Teva Investigational Site 14195 — Savannah, Georgia, United States
• Teva Investigational Site 14217 — Evanston, Illinois, United States
• Teva Investigational Site 14218 — Springfield, Illinois, United States
• Teva Investigational Site 14305 — Louisville, Kentucky, United States
• Teva Investigational Site 14191 — Owensboro, Kentucky, United States
• Teva Investigational Site 14233 — Ann Arbor, Michigan, United States
• Teva Investigational Site 14207 — Bellevue, Nebraska, United States
• Teva Investigational Site 14221 — New York, New York, United States
• Teva Investigational Site 14234 — Chapel Hill, North Carolina, United States
• Teva Investigational Site 14187 — Cincinnati, Ohio, United States
• Teva Investigational Site 14210 — Philadelphia, Pennsylvania, United States
• Teva Investigational Site 14208 — Pittsburgh, Pennsylvania, United States
• Teva Investigational Site 14200 — Providence, Rhode Island, United States
• Teva Investigational Site 14300 — Charleston, South Carolina, United States
• Teva Investigational Site 14196 — Greenville, South Carolina, United States

Full record on ClinicalTrials.gov

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