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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 is a Phase 3 study that was terminated before completion, run by Novartis. The registered enrollment target is 98 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00125346
The ClinicalTrials.gov registry entry for NCT00125346 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 98 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis, which has 265 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Tobramycin Inhalation Powder is the first listed.
NCT00125346 reports 0 study locations.
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.
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