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NCT00388505 · ClinicalTrials.gov registry record · Phase 3
Safety of Tobramycin Inhalation Powder (TIP) vs Tobramycin Solution for Inhalation in Patients With Cystic Fibrosis
A Phase 3 study of Cystic Fibrosis, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 517
- Enrollment target
- 20
- Study locations
NCT00388505: Completed Phase 3 study of Cystic Fibrosis, sponsored by Novartis Pharmaceuticals.
NCT00388505 is a Phase 3 study of Cystic Fibrosis that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 517 participants, above the 176-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (194% higher). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00388505, a Phase 3 study of Cystic Fibrosis, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 517 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study compares the safety of the tobramycin solution for inhalation with the tobramycin dry powder formulation, used with a simple inhaler
Primary Outcome
An adverse event (AE) is any untoward medical occurrence, including any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication that does not necessarily have a causal relationship with study medication. A serious AE (SAE) is an event that results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability, is a congenital anomaly or defect, or is a significant medical event
Conditions Studied
Interventions
- DRUG Tobramycin Inhalation Powder
- DRUG Tobramycin Solution for Inhalation
Study Locations (20)
New York
- Novartis Investigative Site - Albany
- Novartis Investigative Site - Buffalo
- Novartis Investigative Site - New Hyde Park
- Novartis Investigative Site - New York
- University of Rochester - Rochester
- Novartis Investigative Site - Stony Brook
- Novartis Investigative Site - Syracuse
- Novartis Investigative Site - Valhalla
New Jersey
- Novartis Investigative Site - Livingston
- Novartis Investigative Site - Long Branch
- Novartis Investigative Site - Morristown
- Novartis Investigative Site - Somerset
Pennsylvania
- Penn State College of Medicine - Hershey
- Drexel University College of Medicine - Philadelphia
Connecticut
- Novartis Investigative Site - Hartford
Georgia
- Emory University CF Center - Atlanta
Illinois
- Rush University Center - Chicago
Kentucky
- University of Louisville - Louisville
Massachusetts
- Novartis Investigative Site - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 517 participants |
| Start Date | 2006-02 |
| Est. Completion | 2009-03 |
| Phase | Phase 3 |
What the finished NCT00388505 record still lists
NCT00388505 is an interventional study that assigns participants to a tested intervention. The registered 517 participants enrollment target is mid-sized for trials with a published cap, above the 176-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (194% higher).
The record links to 1 condition, with Cystic Fibrosis appearing as the primary indexed condition, and to 2 interventions - of which Tobramycin Inhalation Powder is the first listed.
NCT00388505 names 20 study sites across 9 states, led by New York, New Jersey, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT00388505 about?
NCT00388505 is a clinical study titled "Safety of Tobramycin Inhalation Powder (TIP) vs Tobramycin Solution for Inhalation in Patients With Cystic Fibrosis". This study compares the safety of the tobramycin solution for inhalation with the tobramycin dry powder formulation, used with a simple inhaler
What is the current status of trial NCT00388505?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 517 participants. The study started on 2006-02. Estimated completion is 2009-03.
What conditions does trial NCT00388505 study?
This clinical trial studies the following conditions: Cystic Fibrosis.
What interventions are being tested in trial NCT00388505?
The interventions under investigation include: Tobramycin Inhalation Powder (DRUG), Tobramycin Solution for Inhalation (DRUG).
Who is sponsoring clinical trial NCT00388505?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00388505 being conducted?
This trial has 20 study locations across Connecticut, Georgia, Illinois, Kentucky, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Cystic Fibrosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00388505's enrollment target sits among peer trials
517 11th of 169 higher than 159 of 169 other Cystic Fibrosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cystic Fibrosis 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.
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