Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Phase 3, Open-label, Randomized Trial to Evaluate the Safety and Efficacy of MP-376 Inhalation Solution (Aeroquin) vs. Tobramycin Inhalation Solution (TIS) in Stable CF 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. Bacterial resistance to current aerosol antibiotic treatments indicate a need for improved therapies to treat CF patients with pulmonary infections caused by multi-drug resistant Pseudomonas aeruginosa and other bacteria. High concentrations of MP-376 delivered directly to the lung are projected to have antimicrobial effects on even the most resistant organisms.


Options:
A: Arm Label: Aeroquin; Type: EXPERIMENTAL; Interventions: Drug: MP-376 (Levofloxacin Solution for Inhalation) | Arm Label: TIS; Type: ACTIVE_COMPARATOR; Interventions: Drug: TIS (Tobramycin Inhalation Solution) | Intervention Type: DRUG; Name: MP-376 (Levofloxacin Solution for Inhalation); Assigned to Arm(s): Aeroquin | Intervention Type: DRUG; Name: TIS (Tobramycin Inhalation Solution); Assigned to Arm(s): TIS
B: 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
C: Arm Label: A; Type: ACTIVE_COMPARATOR; Interventions: Drug: Arikayce™ 560 mg | Arm Label: B; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo for 560 mg | Arm Label: C; Type: ACTIVE_COMPARATOR; Interventions: Drug: Arikayce™ 70 mg | Arm Label: D; Type: ACTIVE_COMPARATOR; Interventions: Drug: Arikayce™ 140 mg | Arm Label: E; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo for 70 mg / 140 mg | Intervention Type: DRUG; Name: Arikayce™ 560 mg; Assigned to Arm(s): A | Intervention Type: DRUG; Name: Placebo for 560 mg; Assigned to Arm(s): B | Intervention Type: DRUG; Name: Arikayce™ 70 mg; Assigned to Arm(s): C | Intervention Type: DRUG; Name: Arikayce™ 140 mg; Assigned to Arm(s): D | Intervention Type: DRUG; Name: Placebo for 70 mg / 140 mg; Assigned to Arm(s): E
D: 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

Answer: A