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NCT00125346 · ClinicalTrials.gov registry record · Phase 3
Tobramycin Inhalation Powder (TIP) in Cystic Fibrosis Subjects
A Phase 3 study, sponsored by Novartis.
- Terminated
- Registry status
- Phase 3
- Development phase
- 98
- Enrollment target
NCT00125346: Clinical Trial Phase 3 study, sponsored by Novartis.
NCT00125346 is a Phase 3 study that was terminated before completion, run by Novartis. The registered enrollment target is 98 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00125346, a Phase 3 study, was terminated before completion, sponsored by Novartis.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 98 participants
- Enrollment target
Study Summary
Lung infections are a chronic problem for patients with cystic fibrosis (CF). Some patients with CF may have a type of bacteria called Pseudomonas aeruginosa in their lungs that can cause infections or make their symptoms worse. Tobramycin inhalation solution (TOBI) is an approved antibiotic, which is inhaled directly into the lungs, and can be used to manage these infections. Tobramycin inhalation powder (TIP) is a new, experimental powder formulation of tobramycin that is inhaled directly into the lungs using a T-326 inhaler. The purpose of this research study is to determine if TIP is safe and effective when compared to placebo (a powder with no medicine) treatment.
Interventions
- DRUG Tobramycin Inhalation Powder
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 98 participants |
| Start Date | 2005-09 |
| Est. Completion | 2007-02 |
| Phase | Phase 3 |
Why NCT00125346 stopped before completion
NCT00125346 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 98 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 1 intervention - of which Tobramycin Inhalation Powder is the first listed.
NCT00125346 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00125346 about?
NCT00125346 is a clinical study titled "Tobramycin Inhalation Powder (TIP) in Cystic Fibrosis Subjects". Lung infections are a chronic problem for patients with cystic fibrosis (CF). Some patients with CF may have a type of bacteria called Pseudomonas aeruginosa in their lungs that can cause infections or make their symptoms worse. Tobramycin inhalation solution (TOBI) is an approved antibiotic, which ...
What is the current status of trial NCT00125346?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 98 participants. The study started on 2005-09. Estimated completion is 2007-02.
What interventions are being tested in trial NCT00125346?
The interventions under investigation include: Tobramycin Inhalation Powder (DRUG).
Who is sponsoring clinical trial NCT00125346?
This trial is sponsored by Novartis, which has 265 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00125346's enrollment target sits among peer trials
98 1714th of 2000 higher than 283 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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