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NCT03256695 · ClinicalTrials.gov registry record · Phase 3
Evaluate the Relationship Between Use of Albuterol Multidose Dry Powder Inhaler With an eModule (eMDPI) and Exacerbations in Participants With Chronic Obstructive Pulmonary Disease (COPD)
A Phase 3 study, sponsored by Teva Branded Pharmaceutical Products R&D.
- Completed
- Registry status
- Phase 3
- Development phase
- 405
- Enrollment target
NCT03256695: Completed Phase 3 study, sponsored by Teva Branded Pharmaceutical Products R&D.
NCT03256695 is a Phase 3 study that has completed, run by Teva Branded Pharmaceutical Products R&D. The registered enrollment target is 405 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (48% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03256695, a Phase 3 study, has completed, sponsored by Teva Branded Pharmaceutical Products R&D.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 405 participants
- Enrollment target
Study Summary
This is a Phase 3B, 12-week, multicenter, open-label study to evaluate the relationship between as-needed usage of albuterol eMDPI and Clinical Exacerbation-Chronic Obstructive Pulmonary Disease (CE-COPD) in adult participants at least 40 years of age with exacerbation-prone COPD.
Primary Outcome
CE-COPD was an occurrence of either severe CE-COPD or moderate CE-COPD. Severe CE-COPD was defined as an event that involved worsening respiratory symptoms for at least 2 consecutive days requiring treatment with systemic corticosteroids (SCS; at least 10 milligrams \[mg\] prednisone equivalent above baseline) and/or systemic antibiotics and a hospitalization for CE COPD. Moderate CE-COPD was defined as an event that involved worsening respiratory symptoms for at least 2 consecutive days requir
Interventions
- DRUG Albuterol sulfate (ABS)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 405 participants |
| Start Date | 2017-09-28 |
| Est. Completion | 2018-04-17 |
| Phase | Phase 3 |
What the finished NCT03256695 record still lists
NCT03256695 is an interventional study that assigns participants to a tested intervention. The registered 405 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (48% lower).
The record links to 0 conditions, and to 1 intervention - of which Albuterol sulfate (ABS) is the first listed.
NCT03256695 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03256695 about?
NCT03256695 is a clinical study titled "Evaluate the Relationship Between Use of Albuterol Multidose Dry Powder Inhaler With an eModule (eMDPI) and Exacerbations in Participants With Chronic Obstructive Pulmonary Disease (COPD)". This is a Phase 3B, 12-week, multicenter, open-label study to evaluate the relationship between as-needed usage of albuterol eMDPI and Clinical Exacerbation-Chronic Obstructive Pulmonary Disease (CE-COPD) in adult participants at least 40 years of age with exacerbation-prone COPD.
What is the current status of trial NCT03256695?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 405 participants. The study started on 2017-09-28. Estimated completion is 2018-04-17.
What interventions are being tested in trial NCT03256695?
The interventions under investigation include: Albuterol sulfate (ABS) (DRUG).
Who is sponsoring clinical trial NCT03256695?
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 NCT03256695's enrollment target sits among peer trials
405 914th of 2000 higher than 1,087 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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