Trials / Completed
CompletedNCT00982930
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) Subjects Who Completed Participation in Study CTBM100C2303.
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 55 (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 had completed their study participation in CTBM100C2303 (all visits) and who were proven infected with Pseudomonas aeruginosa (P. aeruginosa) at enrollment into CTBM100C2303.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Tobramycin inhalation powder | Tobramycin inhalation powder, 112 mg (4 capsules of 28 mg), inhalation capsules, b.i.d. |
Timeline
- Start date
- 2009-08-12
- Primary completion
- 2011-10-01
- Completion
- 2011-10-06
- First posted
- 2009-09-23
- Last updated
- 2021-06-02
- Results posted
- 2021-06-02
Locations
2 sites across 2 countries: Estonia, Russia
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT00982930. Inclusion in this directory is not an endorsement.