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NCT03502070 · ClinicalTrials.gov registry record · Phase 4
Human Factors Study to Validate the User Interface of TOBI Podhaler Using Placebo Capsules
A Phase 4 study, sponsored by Mylan.
- Completed
- Registry status
- Phase 4
- Development phase
- 47
- Enrollment target
NCT03502070: Completed Phase 4 study, sponsored by Mylan.
NCT03502070 is a Phase 4 study that has completed, run by Mylan. The registered enrollment target is 47 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03502070, a Phase 4 study, has completed, sponsored by Mylan.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 47 participants
- Enrollment target
Study Summary
The purpose of this study is to validate the user interface of TOBI Podhaler by establishing that the product can support safe and effective use for the intended users
Primary Outcome
Critical use errors and close calls for the following: placing of capsule into the top of the mouthpiece, failure to replace mouthpiece, failure to adequately pierce capsule, failure to release before inhaling, multiple piercing of capsule, exhalation into mouthpiece, inadequate seal around mouthpiece, inadequate inhalation technique, failure to use reserve device when capsule not adequately pierced, failure to administer 4 capsules per dose, swallowing of capsule
Interventions
- DRUG Placebo
- DEVICE Tobi Podhaler
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 47 participants |
| Start Date | 2018-06-26 |
| Est. Completion | 2019-06-17 |
| Phase | Phase 4 |
What the finished NCT03502070 record still lists
NCT03502070 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 47 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03502070 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03502070 about?
NCT03502070 is a clinical study titled "Human Factors Study to Validate the User Interface of TOBI Podhaler Using Placebo Capsules". The purpose of this study is to validate the user interface of TOBI Podhaler by establishing that the product can support safe and effective use for the intended users
What is the current status of trial NCT03502070?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 47 participants. The study started on 2018-06-26. Estimated completion is 2019-06-17.
What interventions are being tested in trial NCT03502070?
The interventions under investigation include: Placebo (DRUG), Tobi Podhaler (DEVICE).
Who is sponsoring clinical trial NCT03502070?
This trial is sponsored by Mylan, which has 22 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03502070's enrollment target sits among peer trials
47 1348th of 2000 higher than 653 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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