Allergy & Immunology
PHASE4
● Phase IV
Can a smart inhaler help people with uncontrolled asthma breathe easier?
ClinicalTrials.gov
Published March 30, 2026
Teva Branded Pharmaceutical Products R&D, Inc.
Imagine having asthma that just doesn't stay under control, no matter what you try. Researchers recently tested whether adding digital technology to a common rescue inhaler could help people in exactly that situation. They enrolled 333 participants, aged 13 and older, all of whom had what doctors call 'suboptimal asthma control.' For 12 weeks, one group used a new 'smart' albuterol inhaler system that connects to an app and a digital platform, while another group stuck with their standard inhaler.
The big question was: did more people using the digital system achieve meaningful improvement in their asthma? The answer isn't available yet—the study's main results haven't been reported. This was a feasibility study, which is an important early step to see if a larger, more definitive trial is even possible to run. It wasn't designed to prove the system works, just to evaluate the process of testing it.
It's also important to know this was an 'open-label' study, meaning everyone knew which inhaler they were using, which can sometimes influence how people report their symptoms. The study was funded by the company that makes the digital system. Without the results, we simply don't know if this technology helps, or if it's safe and tolerable for everyday use. The next step would be a larger trial designed to answer those questions.
View Original Abstract ↓
Status: COMPLETED | Phase: PHASE4
Condition(s): Asthma
Intervention(s): Albuterol eMDPI DS (DRUG), albuterol (DRUG)
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.
Primary Outcome(s): Percentage of Participants Achieving Meaningful Asthma Improvement at the End of 12-Week Treatment Period
Enrollment: 333 (ACTUAL)
Lead Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Start: 2020-10-26 | Primary Completion: 2021-10-04
Results posted: 2022-10-27
