Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Phase II, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Safety, Tolerability and Efficacy of Three Dosage Regimens of MP-376 Solution for Inhalation Given for 28 Days to 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: 32.50 mg Ciprofloxacin DPI (BAYQ3939); Type: EXPERIMENTAL; Interventions: Drug: Ciprofloxacin (Cipro Inhale, BAYQ3939) | Arm Label: 48.75 mg Ciprofloxacin DPI (BAYQ3939); Type: EXPERIMENTAL; Interventions: Drug: Ciprofloxacin (Cipro Inhale, BAYQ3939) | Arm Label: Matching Placebo for 32.50 mg; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Arm Label: Matching Placebo for 48.75 mg; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Ciprofloxacin (Cipro Inhale, BAYQ3939); Assigned to Arm(s): 32.50 mg Ciprofloxacin DPI (BAYQ3939) | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Matching Placebo for 32.50 mg | Intervention Type: DRUG; Name: Ciprofloxacin (Cipro Inhale, BAYQ3939); Assigned to Arm(s): 48.75 mg Ciprofloxacin DPI (BAYQ3939) | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Matching Placebo for 48.75 mg
B: Arm Label: Bramitob; Type: EXPERIMENTAL; Interventions: Drug: tobramycin / Bramitob | Arm Label: TOBI; Type: ACTIVE_COMPARATOR; Interventions: Drug: tobramycin / TOBI | Intervention Type: DRUG; Name: tobramycin / Bramitob; Assigned to Arm(s): Bramitob | Intervention Type: DRUG; Name: tobramycin / TOBI; Assigned to Arm(s): TOBI
C: 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
D: Arm Label: Tobramycin 300 mg for 28 days; Type: EXPERIMENTAL; Interventions: Drug: Tobramycin solution for inhalation 300 mg | Arm Label: Tobramycin 300 mg for 56 days; Type: EXPERIMENTAL; Interventions: Drug: Tobramycin solution for inhalation 300 mg | Intervention Type: DRUG; Name: Tobramycin solution for inhalation 300 mg; Assigned to Arm(s): Tobramycin 300 mg for 28 days, Tobramycin 300 mg for 56 days

Answer: C