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NCT01519661 · ClinicalTrials.gov registry record · Phase 4
Long Term Safety of Tobramycin Inhalation Powder in Patients With Cystic Fibrosis
A Phase 4 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 4
- Development phase
- 157
- Enrollment target
NCT01519661: Completed Phase 4 study, sponsored by Novartis Pharmaceuticals.
NCT01519661 is a Phase 4 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 157 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01519661, a Phase 4 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 157 participants
- Enrollment target
Study Summary
This study assessed the long term safety data for the use of tobramycin inhalation powder in patients suffering from cystic fibrosis who have a chronic pulmonary infection with Pseudomonas aeruginosa.
Primary Outcome
Adverse events were deemed treatment-emergent if the onset date/time was on or after the date and time of first study drug. All adverse events were included after this time during both on and off-treatment periods.
Interventions
- DRUG TBM100
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 157 participants |
| Start Date | 2012-01 |
| Est. Completion | 2014-01 |
| Phase | Phase 4 |
What the finished NCT01519661 record still lists
NCT01519661 is an interventional study that assigns participants to a tested intervention. The registered 157 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 (70% lower).
The record links to 0 conditions, and to 1 intervention - of which TBM100 is the first listed.
NCT01519661 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01519661 about?
NCT01519661 is a clinical study titled "Long Term Safety of Tobramycin Inhalation Powder in Patients With Cystic Fibrosis". This study assessed the long term safety data for the use of tobramycin inhalation powder in patients suffering from cystic fibrosis who have a chronic pulmonary infection with Pseudomonas aeruginosa.
What is the current status of trial NCT01519661?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 157 participants. The study started on 2012-01. Estimated completion is 2014-01.
What interventions are being tested in trial NCT01519661?
The interventions under investigation include: TBM100 (DRUG).
Who is sponsoring clinical trial NCT01519661?
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 NCT01519661's enrollment target sits among peer trials
157 519th of 2000 higher than 1,480 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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