Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Phase 2a Multidose Safety and Tolerability Study of Dose Escalation of Liposomal Amikacin for Inhalation (ARIKACE™) In Cystic Fibrosis Patients With Chronic Infections Due To Pseudomonas Aeruginosa.
Brief Summary: A major factor in the respiratory health of cystic fibrosis (CF) subjects is acquisition of chronic Pseudomonas aeruginosa infections. The infection rate with P. aeruginosa increases with age and by age 18 years, 80% of CF subjects in the U.S. are infected. Liposomal Amikacin for Inhalation (Arikace™) is a sterile aqueous liposomal suspension consisting of amikacin sulfate encapsulated in liposomes. This formulation of amikacin maximizes the achievable dose and delivery to the lungs of subjects infected via a nebulizer. Because liposome particles are small enough to penetrate and diffuse through sputum into the bacterial biofilm, they deposit drug in close proximity to the bacterial colonies, thus improving the bioavailability of amikacin at the infection site. The clinically achievable doses of amikacin in the LAI formulation can effectively increase the half-life of the drug in the lungs, and decrease the potential for systemic toxicity. LAI offers several advantages over current therapies in treating CF subjects with chronic infection caused by P. aeruginosa.


Options:
A: Arm Label: Cycled TOBI & placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Tobramycin solution for inhalation (TOBI), Drug: Oral placebo | Arm Label: Cycled TOBI & oral ciprofloxacin; Type: ACTIVE_COMPARATOR; Interventions: Drug: Tobramycin solution for inhalation (TOBI), Drug: Oral ciprofloxacin | Arm Label: Culture based TOBI & placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Tobramycin solution for inhalation (TOBI), Drug: Oral placebo | Arm Label: Culture based TOBI & oral cipro; Type: ACTIVE_COMPARATOR; Interventions: Drug: Tobramycin solution for inhalation (TOBI), Drug: Oral ciprofloxacin | Intervention Type: DRUG; Name: Tobramycin solution for inhalation (TOBI); Assigned to Arm(s): Culture based TOBI & oral cipro, Culture based TOBI & placebo, Cycled TOBI & oral ciprofloxacin, Cycled TOBI & placebo | Intervention Type: DRUG; Name: Oral placebo; Assigned to Arm(s): Culture based TOBI & placebo, Cycled TOBI & placebo | Intervention Type: DRUG; Name: Oral ciprofloxacin; Assigned to Arm(s): Culture based TOBI & oral cipro, Cycled TOBI & oral ciprofloxacin
B: Arm Label: AZLI; Type: ACTIVE_COMPARATOR; Interventions: Drug: AZLI, Drug: Tobramycin inhalation solution | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo to match AZLI, Drug: Tobramycin inhalation solution | Intervention Type: DRUG; Name: AZLI; Assigned to Arm(s): AZLI | Intervention Type: DRUG; Name: Placebo to match AZLI; Assigned to Arm(s): Placebo | Intervention Type: DRUG; Name: Tobramycin inhalation solution; Assigned to Arm(s): AZLI, Placebo
C: Arm Label: Tobramycin 300 mg for 28 days; Type: EXPERIMENTAL; Interventions: Drug: Tobramycin solution for inhalation 300 mg | Arm Label: Tobramycin 300 mg for 56 days; Type: EXPERIMENTAL; Interventions: Drug: Tobramycin solution for inhalation 300 mg | Intervention Type: DRUG; Name: Tobramycin solution for inhalation 300 mg; Assigned to Arm(s): Tobramycin 300 mg for 28 days, Tobramycin 300 mg for 56 days
D: Arm Label: Cohort 1 - 280 mg ARIKACE™; Type: EXPERIMENTAL; Interventions: Drug: ARIKACE™ | Arm Label: Cohort 1 - Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Arm Label: Cohort 2 - 560 mg ARIKACE™; Type: EXPERIMENTAL; Interventions: Drug: ARIKACE™ | Arm Label: Cohort 2 - Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: ARIKACE™; Assigned to Arm(s): Cohort 1 - 280 mg ARIKACE™, Cohort 2 - 560 mg ARIKACE™ | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Cohort 1 - Placebo, Cohort 2 - Placebo

Answer: D