Trials / Completed
CompletedNCT00634192
Pharmacokinetic Evaluation of an 8 -Week Treatment With Inhaled Tobramycin
A Multicenter, Open Label, 2 Period Cross-over Study to Evaluate the PK of a 8 Week Continuous Treatment With 1x300mg/d and 2x300mg/d Tobramycin Inhaled With a 'Soft Mist' Nebulizer in Cystic Fibrosis (CF) Subjects
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- Sponsor
- Novartis · Industry
- Sex
- All
- Age
- 6 Years
- Healthy volunteers
- —
Summary
This study is designed to provide data about the pharmacokinetics (PK), safety and tolerability of two continuous treatment regimes of tobramycin nebulized solution delivered via a 'soft mist' nebulizer in Cystic Fibrosis (CF) subjects. Each treatment period will last 8 weeks. Additionally the PK of patients with a normal forced expiratory flow in 1 second (FEV1) (FEV1≥80% predicted) will be compared to patients with an abnormal FEV1 (FEV1\<80% predicted).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | tobramycin | 1x300mg/d inhaled |
| DRUG | tobramycin | 2x300mg/d inhaled |
Timeline
- Start date
- 2008-02-01
- Primary completion
- 2009-02-01
- Completion
- 2009-08-01
- First posted
- 2008-03-12
- Last updated
- 2017-02-24
Locations
8 sites across 1 country: Germany
Source: ClinicalTrials.gov record NCT00634192. Inclusion in this directory is not an endorsement.