Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TOBI · 1 trial · 1 indication
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...
TOBI is used for the treatment of early pulmonary infections with P. aeruginosa in cystic fibrosis patients. It is a small molecule respiratory therapy being developed by Novartis AG for this indication, specifically studied in patients between 3 months and less than 7 years of age.
TOBI targets P. aeruginosa, the bacterium that causes early pulmonary infections in cystic fibrosis patients. It is an antibiotic designed to treat these infections, which are a common complication in cystic fibrosis. The drug is administered to reduce the bacterial load in the lungs of affected patients.
TOBI is developed by Novartis AG, a multinational pharmaceutical company listed on the stock exchange under the ticker NVS. Novartis is conducting clinical trials to evaluate the safety and efficacy of TOBI in treating early pulmonary infections with P. aeruginosa in cystic fibrosis patients.
TOBI is in Phase 3 clinical development. It has completed a Phase 3 trial (NCT01082367) that enrolled 50 patients. The drug is investigational and has not been approved by regulatory authorities based on the available information. It remains in clinical development for the treatment of early pulmonary infections in cystic fibrosis.
TOBI has one completed Phase 3 clinical trial, NCT01082367, titled 'Randomized, Controlled Study of CF Patients Between 3 Months and Less Than 7 Years'. This double-blind, placebo-controlled trial enrolled 50 patients across multiple countries including Canada, Egypt, France, Germany, Greece, Hungary, Italy, Romania, Russia, and Switzerland.
TOBI is a brand name for a formulation of tobramycin, an aminoglycoside antibiotic. It is specifically developed for inhalation to treat pulmonary infections in cystic fibrosis patients. The drug is being studied for early P. aeruginosa infections, and the clinical trial data supports its use in this patient population.