Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Liposomal amikacin for using the PARI Investigational eFlow Nebulizer · 1 trial · 1 indication
Relative Change (%) from baseline to end of study (Day 168) in FEV1 (1 second)
| Arm | Type | Description |
|---|---|---|
| Arikayce™ | EXPERIMENTAL | Arikayce™ is liposomal amikacin for inhalation |
| TOBI® | ACTIVE_COMPARATOR | TOBI® is tobramycin inhalation solution |
| Name | Type | Description |
|---|---|---|
| Liposomal amikacin for inhalation (Arikayce™) using the PARI Investigational eFlow® Nebulizer. | DRUG | Liposomal amikacin for inhalation is provided as a sterile aqueous liposomal dispersion for inhalation via nebulization. * 590 mg of liposomal amikacin for inhalation is administered once daily using the PARI Investigational eFlow® Nebulizer. * Administration time is approximately 13 minutes. * liposomal amikacin for inhalation will be administered for 3 cycles where each cycle consists of 28 days on-treatment followed by 28 days off-treatment. |
| Tobramycin inhalation solution using a PARI LC® Plus nebulizer. | DRUG | 300 mg tobramycin inhalation solution is administered twice a day using a PARI LC® Plus nebulizer. * Nebulization time is approximately 20 minutes for each administration. * Tobramycin inhalation solution will be administered for 3 cycles where each cycle consists of 28 days on-treatment followed by 28 days off-treatment |
Key Inclusion Criteria: * Written informed consent or assent * Confirmed diagnosis of CF * History of chronic infection with Pseudomonas aeruginosa * Sputum culture positive for Pseudomonas aeruginosa at Screening * FEV1 ≥ 25% of predicted value at Screening Key Exclusion Criteria: * FEV1 \<25% o...