Ext. Long-term Safety Study in CF Patients: Single Arm TIP
| Status: | Completed |
|---|---|
| Conditions: | Pulmonary |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 6 - Any |
| Updated: | 4/21/2016 |
| Start Date: | February 2013 |
| End Date: | November 2014 |
A 48 Week Extension to CTBM100C2401, a Single Arm, Open-label, Multicenter, Phase IV Extension Trial to Assess Long Term Safety of Tobramycin Inhalation Powder (TIP) in Patients With Cystic Fibrosis Who Completed Participation in CTBM100C2401.
The purpose of this extension study is to collect additional 48 weeks of safety data from
patients taking TIP who have completed the core study CTBM100C2401. The purpose of
collecting second year safety data through this study is to obtain long-term (2 years)
safety data of TIP.
patients taking TIP who have completed the core study CTBM100C2401. The purpose of
collecting second year safety data through this study is to obtain long-term (2 years)
safety data of TIP.
Inclusion Criteria:
- Completion of the core study CTBM100C2401 and able to comply with all protocol
requirements of the extension study
Exclusion Criteria:
- Serum creatinine 2mg/dl, BUN 40mg/dl or proteinuria 2+ or more at the time of entry
into the extension
- Use of loop diuretics within 7 days prior to entry into the extension study
- Pregnant or nursing women
- Women of child bearing potential unless using highly effective method of
contraception as indicated in the protoco
We found this trial at
5
sites
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