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NCT03890666 · ClinicalTrials.gov registry record · Phase 4
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
A Phase 4 study, sponsored by Teva Branded Pharmaceutical Products R&D.
- Completed
- Registry status
- Phase 4
- Development phase
- 333
- Enrollment target
NCT03890666: Completed Phase 4 study, sponsored by Teva Branded Pharmaceutical Products R&D.
NCT03890666 is a Phase 4 study that has completed, run by Teva Branded Pharmaceutical Products R&D. The registered enrollment target is 333 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (36% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03890666, a Phase 4 study, has completed, sponsored by Teva Branded Pharmaceutical Products R&D.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 333 participants
- Enrollment target
Study Summary
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
Meaningful asthma improvement was defined as an Asthma Control Test (ACT) score of at least 20 at the end of the 12-week treatment period or an increase of at least 3 units on the ACT score from baseline at the end of the 12-week treatment period. The ACT was a simple, participant-completed tool used to assess overall asthma control. The 5 items included in the ACT assess daytime and night-time asthma symptoms, use of reliever medication, and impact of asthma on daily functioning. Each item in t
Interventions
- DRUG albuterol
- DRUG Albuterol eMDPI DS
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 333 participants |
| Start Date | 2020-10-26 |
| Est. Completion | 2021-10-04 |
| Phase | Phase 4 |
What the finished NCT03890666 record still lists
NCT03890666 is an interventional study that assigns participants to a tested intervention. The registered 333 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (36% lower).
The record links to 0 conditions, and to 2 interventions - of which albuterol is the first listed.
NCT03890666 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03890666 about?
NCT03890666 is a clinical study titled "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". 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 parti...
What is the current status of trial NCT03890666?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 333 participants. The study started on 2020-10-26. Estimated completion is 2021-10-04.
What interventions are being tested in trial NCT03890666?
The interventions under investigation include: albuterol (DRUG), Albuterol eMDPI DS (DRUG).
Who is sponsoring clinical trial NCT03890666?
This trial is sponsored by Teva Branded Pharmaceutical Products R&D, which has 167 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03890666's enrollment target sits among peer trials
333 252nd of 2000 higher than 1,748 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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