Trials / Completed
CompletedNCT01069705
Second Open Label Extension to Bridging Study CTBM100C2303
A Phase III Open-Label Extension Study to Assess the Safety and Efficacy of Tobramycin Inhalation Powder After Manufacturing Process Modifications (TIPnew) in Cystic Fibrosis (CF) Patients Who Successfully Completed Participation in Study CTBM100C2303E1
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 49 (actual)
- Sponsor
- Novartis Pharmaceuticals · Industry
- Sex
- All
- Age
- 6 Years – 21 Years
- Healthy volunteers
- Not accepted
Summary
This was an open-label, single arm (uncontrolled) study in participants suffering from cystic fibrosis, who have completed their study participation in CTBM100C2303 and extension study one CTBM100C2303E1 (all visits), who were proven infected with Pseudomonas aeruginosa at enrollment into CTBM100C2303.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Tobramycin inhalation powder | Tobramycin dry powder for inhalation in capsules administered by the T-326 inhaler. |
Timeline
- Start date
- 2010-02-12
- Primary completion
- 2012-03-19
- Completion
- 2012-03-19
- First posted
- 2010-02-17
- Last updated
- 2021-06-02
- Results posted
- 2021-06-02
Locations
17 sites across 7 countries: Bulgaria, Estonia, Latvia, Lithuania, Romania, Russia, South Africa
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT01069705. Inclusion in this directory is not an endorsement.