Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Aztreonam for Inhalation Solution (AZLI) in a Continuous Alternating Therapy (CAT) Regimen of Inhaled Antibiotics for the Treatment of Chronic Pulmonary Pseudomonas Aeruginosa Infection in Subjects With Cystic Fibrosis
Brief Summary: The primary objective of this study is to evaluate the safety and efficacy of a CAT regimen with aztreonam for inhalation solution (AZLI) and tobramycin inhalation solution (TIS) in adult and pediatric subjects with cystic fibrosis (CF) and pulmonary Pseudomonas aeruginosa (PA) infection. Participants will be enrolled in a 28 day TIS run-in phase, and will be eligible for randomization in the comparative phase if they have not received non-study oral antibiotics for a respiratory event, or IV or inhaled antibiotics for any indication between Visits 2 and 3, have not developed a condition requiring hospitalization or other change in clinical status which, in the opinion of the investigator would preclude their ability to continue in the study, and have demonstrated at least 50% TIS compliance. Participants enrolled in the comparative phase will be randomized to receive 3 cycles of treatment, each cycle consisting alternating regimens: AZLI or placebo for 28 days followed by TIS for 28 days.


Options:
A: Arm Label: Observational; Type: N/A; Interventions: N/A
B: 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)
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: D