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: 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
B: Arm Label: CF patients with pulmonary exacerbations; Type: N/A; Interventions: N/A
C: 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
D: 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

Answer: A