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: 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
B: Arm Label: Aeroquin 240 mg; Type: EXPERIMENTAL; Interventions: Drug: Aeroquin | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Aeroquin; Assigned to Arm(s): Aeroquin 240 mg | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo
C: Arm Label: Placebo (pooled two times a day [BID]/three times a day [TID]); Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo two times a day (BID)/three times a day (TID) | Arm Label: AZLI (pooled two times a day [BID]/three times a day [TID]); Type: EXPERIMENTAL; Interventions: Drug: AZLI 75 mg two times a day (BID)/three times a day (TID) | Intervention Type: DRUG; Name: AZLI 75 mg two times a day (BID)/three times a day (TID); Assigned to Arm(s): AZLI (pooled two times a day [BID]/three times a day [TID]) | Intervention Type: DRUG; Name: Placebo two times a day (BID)/three times a day (TID); Assigned to Arm(s): Placebo (pooled two times a day [BID]/three times a day [TID])
D: Arm Label: Placebo three times daily (TID); Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo three times daily (TID) | Arm Label: AZLI 75 mg three times daily (TID); Type: EXPERIMENTAL; Interventions: Drug: AZLI 75 mg three times daily (TID) | Intervention Type: DRUG; Name: AZLI 75 mg three times daily (TID); Assigned to Arm(s): AZLI 75 mg three times daily (TID) | Intervention Type: DRUG; Name: Placebo three times daily (TID); Assigned to Arm(s): Placebo three times daily (TID)

Answer: A