Clinical trial
Efficacy and Safety of 28 or 56 Day Treatment for Pseudomonas Aeruginosa in…
NCT00391976 · Novartis, Industry · Completed
Key facts
| NCT number | NCT00391976 |
|---|---|
| Title | Efficacy and Safety of 28 or 56 Day Treatment for Pseudomonas Aeruginosa in Children With Cystic Fibrosis |
| Official title | The Microbiologic Efficacy and Safety of Two Treatment Regimens of Inhaled Tobramycin Nebuliser Solution (TNS) for the Treatment of Early Onset Pseudomonas Aeruginosa Lower Respiratory Tract Infection in Subjects With Cystic Fibrosis |
| Acronym | ELITE |
| Lead sponsor | Novartis, Industry |
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Cystic Fibrosis |
| Intervention type | Drug |
| Interventions | Tobramycin solution for inhalation 300 mg |
| Enrollment | 123 |
| Start date | Nov 1, 2003 |
| Primary completion | Jan 1, 2008 |
| Completion | Jan 1, 2008 |
| First posted | Oct 25, 2006 |
| Last update posted | Aug 29, 2011 |
At a glance
- Yes Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: