Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam for Inhalation Solution (AZLI) Versus Tobramycin Inhalation Solution (TIS) in an Intermittent Aerosolized Antibiotic Regimen in Subjects With Cystic Fibrosis Followed by an Open-Label, Single Arm Extension (European Union [EU] Only)
Brief Summary: The purpose of this study was to assess the comparative safety and effectiveness of aztreonam for inhalation solution versus tobramycin inhalation solution in adult and pediatric patients with cystic fibrosis (CF) and pulmonary Pseudomonas aeruginosa (PA) infection.


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: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Arm Label: MP-376 120 mg QD; Type: EXPERIMENTAL; Interventions: Drug: MP-376 | Arm Label: MP-376 240 mg QD; Type: EXPERIMENTAL; Interventions: Drug: MP-376 | Arm Label: MP-376 240 mg BID; Type: EXPERIMENTAL; Interventions: Drug: MP-376 | Intervention Type: DRUG; Name: MP-376; Assigned to Arm(s): MP-376 120 mg QD, MP-376 240 mg BID, MP-376 240 mg QD | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo
C: Arm Label: AZLI 75 mg 3 times a day (TID); Type: EXPERIMENTAL; Interventions: Drug: Aztreonam for Inhalation Solution (AZLI) | Arm Label: TIS 300 mg 2 times a day (BID); Type: ACTIVE_COMPARATOR; Interventions: Drug: Tobramycin Inhalation Solution (TIS) | Intervention Type: DRUG; Name: Aztreonam for Inhalation Solution (AZLI); Assigned to Arm(s): AZLI 75 mg 3 times a day (TID) | Intervention Type: DRUG; Name: Tobramycin Inhalation Solution (TIS); Assigned to Arm(s): TIS 300 mg 2 times a day (BID)
D: 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

Answer: C