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NCT02178540 · ClinicalTrials.gov registry record · Phase 4
Study to Validate the Instructions for Use of TOBI® Podhaler™ in Cystic Fibrosis Patients
A Phase 4 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 4
- Development phase
- 45
- Enrollment target
NCT02178540: Completed Phase 4 study, sponsored by Novartis Pharmaceuticals.
NCT02178540 is a Phase 4 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 45 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
NCT02178540, a Phase 4 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 45 participants
- Enrollment target
Study Summary
The purpose of this actual use human factors (HF) study is to validate the approved US TOBI Podhaler Instructions for Use (IFU), by establishing that the IFU effectively communicates the information necessary to achieve safe and effective use of the Podhaler device.
Primary Outcome
Recording all use errors and close calls associated with inhalation of one dose of TOBI Podhaler (i.e., inhaling the contents of four placebo capsules via the Podhaler device) by subjects (CF patients, and caregivers, if applicable). The study population consisted of CF patients (and caregivers) naïve to the Podhaler device and untrained in the use of the device. Assessing the root cause of use errors and close calls for 6 defined critical errors (agreed with the FDA) and establishing those whic
Interventions
- DRUG Placebo
- DEVICE Tobi Podhaler
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2014-08 |
| Est. Completion | 2015-02 |
| Phase | Phase 4 |
What the finished NCT02178540 record still lists
NCT02178540 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 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.
NCT02178540 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02178540 about?
NCT02178540 is a clinical study titled "Study to Validate the Instructions for Use of TOBI® Podhaler™ in Cystic Fibrosis Patients". The purpose of this actual use human factors (HF) study is to validate the approved US TOBI Podhaler Instructions for Use (IFU), by establishing that the IFU effectively communicates the information necessary to achieve safe and effective use of the Podhaler device.
What is the current status of trial NCT02178540?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 45 participants. The study started on 2014-08. Estimated completion is 2015-02.
What interventions are being tested in trial NCT02178540?
The interventions under investigation include: Placebo (DRUG), Tobi Podhaler (DEVICE).
Who is sponsoring clinical trial NCT02178540?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02178540's enrollment target sits among peer trials
45 1354th of 2000 higher than 638 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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