Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Phase 3, Multi-Center, Multinational, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of MP-376 (Levofloxacin Inhalation Solution; Aeroquin™) In Stable Cystic Fibrosis Patients
Brief Summary: Patients with cystic fibrosis (CF) suffer from chronic infections of the lower respiratory tract that can be caused by one or multiple bacteria, including Pseudomonas aeruginosa, which has been particularly problematic to eradicate and been implicated as the major cause of morbidity and mortality in CF patients. Aerosol delivery of antibiotics directly to the lung increases the local concentrations of antibiotic at the site of infection resulting in improved antimicrobial effects compared to systemic administration. Decreased efficacy, intolerance and high treatment burden with currently available therapies indicate a need for additional therapies. MP-376 (Aeroquin™) is a novel formulation of the fluoroquinolone levofloxacin that has been optimized for aerosol delivery. Preclinical and clinical studies conducted to date show that aerosol doses of MP-376 are safe and well tolerated, exert an antimicrobial effect, improve lung function and reduce the need for other anti-pseudomonal antibiotics. High concentrations of levofloxacin in the lung delivered as MP-376 are active against CF pathogens including those with high minimum inhibitory concentration (MIC) levels to aminoglycosides such as tobramycin (TOBI®) and other inhaled antimicrobial agents. Inhaled MP-376 can be delivered rapidly and efficiently using a customized PARI investigational configuration of the eFlow® nebulizer system.


Options:
A: Arm Label: AZLI then Standard Care; Type: EXPERIMENTAL; Interventions: Drug: Aztreonam, Drug: Standard Care | Arm Label: Standard Care then AZLI; Type: ACTIVE_COMPARATOR; Interventions: Drug: Aztreonam, Drug: Standard Care | Intervention Type: DRUG; Name: Aztreonam; Assigned to Arm(s): AZLI then Standard Care, Standard Care then AZLI | Intervention Type: DRUG; Name: Standard Care; Assigned to Arm(s): AZLI then Standard Care, Standard Care then AZLI
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: 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
D: Arm Label: Placebo three times a day (TID); Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo three times a day (TID) | Arm Label: AZLI 75 mg three times a day (TID); Type: EXPERIMENTAL; Interventions: Drug: AZLI 75 mg three times a day (TID) | Intervention Type: DRUG; Name: AZLI 75 mg three times a day (TID); Assigned to Arm(s): AZLI 75 mg three times a day (TID) | Intervention Type: DRUG; Name: Placebo three times a day (TID); Assigned to Arm(s): Placebo three times a day (TID)

Answer: B