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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 is a Phase 4 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 45 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02178540
The ClinicalTrials.gov registry entry for NCT02178540 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 45 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02178540 reports 0 study locations.
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.
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