Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01082367 | Randomized, Controlled Study of CF Patients Between 3 Months and Less Than 7 Years | PHASE3 | COMPLETED | 50 | — | — | Apr 1, 2010 | Jun 1, 2015 | Jul 15, 2016 | 19 | Canada, Egypt +8 |
Sputum/throat swab cultures were assessed.
| Arm | Type | Description |
|---|---|---|
| TOBI (tobramycin inhaled solution)/Placebo | EXPERIMENTAL | Participants randomized to TOBI received the investigational treatment for 28 days twice daily (bi)d in the first treatment cycle. At the end of first treatment cycle, participants who were positive for P. aeruginosa entered the open label (OL) phase of the study and received TOBI for 28 days bid. Participants who were negative for P. aeruginosa at the end of first treatment cycle and agreed to participate in the cross-over treatment period received placebo for 28 days bid (second treatment cycle). |
| Placebo/TOBI | PLACEBO_COMPARATOR | Participants randomized to placebo group received 0.9 % saline (NaCl) for 28 days bid in the first treatment cycle. At the end of first treatment cycle, participants who were positive for P. aeruginosa entered the OL phase of the study and received TOBI for 28 days bid. Participants who were negative for P. aeruginosa at the end of first treatment cycle and agreed to participate in the cross-over treatment period received TOBI for 28 days bid (second treatment cycle). |
| Name | Type | Description |
|---|---|---|
| TOBI | DRUG | TOBI (tobramycin inhaled solution) |
| Placebo | DRUG | Placebo |
Inclusion Criteria: * Diagnosis of cystic fibrosis * Early lower respiratory tract infection with P. aeruginosa, Exclusion Criteria: * Known local or systemic hypersensitivity to aminoglycosides or inhaled antibiotics. * Administration of loop diuretics within 7 days prior to study drug administr...