Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Phase 2, Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Safety, Tolerability and Efficacy of MP-376 Inhalation Solution Administered for 5 Days Every 28 Days to Prevent Acute Exacerbations in High Risk COPD Patients
Brief Summary: Patients with Chronic Obstructive Pulmonary Disease (COPD) suffer from frequent and recurrent acute exacerbations (AECB) which are associated with enormous healthcare expenditures and significant morbidity, specifically an increased risk of death, a decline in pulmonary function and a significant change in quality of life. Bacteria appear to have an important role in acute exacerbations in chronic bronchitis and COPD. Studies of acute exacerbations in COPD have shown a reduction in bacterial load with prolonged exacerbation-free interval. In addition, recent studies indicate that acquisition of a new strain of H. influenzae, M. catarrhalis, S. pneumoniae or P. aeruginosa are responsible for many of these exacerbations. Chronic inflammation and bacterial infection predispose many patients to frequent and recurrent acute exacerbations.

Mpex believes that intermittent administration of inhaled MP-376 in high risk patients will decrease the incidence of acute exacerbations by both by lowering the organism burden, and resultant inflammation, as well as pre-emptive eradication of any newly acquired bacterial strains.


Options:
A: Arm Label: Roflumilast; Type: ACTIVE_COMPARATOR; Interventions: Drug: Roflumilast | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Roflumilast; Assigned to Arm(s): Roflumilast | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo
B: Arm Label: Tiotropium + Placebo; Type: ACTIVE_COMPARATOR; Interventions: Drug: Tiotropium bromide, Drug: Placebo Salmeterol | Arm Label: Salmeterol + Placebo; Type: ACTIVE_COMPARATOR; Interventions: Drug: Salmeterol, Drug: Placebo Tiotropium | Intervention Type: DRUG; Name: Tiotropium bromide; Assigned to Arm(s): Tiotropium + Placebo | Intervention Type: DRUG; Name: Salmeterol; Assigned to Arm(s): Salmeterol + Placebo | Intervention Type: DRUG; Name: Placebo Salmeterol; Assigned to Arm(s): Tiotropium + Placebo | Intervention Type: DRUG; Name: Placebo Tiotropium; Assigned to Arm(s): Salmeterol + Placebo
C: Arm Label: Relovair; Type: EXPERIMENTAL; Interventions: Drug: fluticasone furoate (FF, GW685698)/vilanterol (VI, GW642444) 100/25 mcg Novel Dry Powder Inhaler (NDPI) | Arm Label: Tiotropium; Type: ACTIVE_COMPARATOR; Interventions: Drug: Tiotropium | Intervention Type: DRUG; Name: fluticasone furoate (FF, GW685698)/vilanterol (VI, GW642444) 100/25 mcg Novel Dry Powder Inhaler (NDPI); Assigned to Arm(s): Relovair | Intervention Type: DRUG; Name: Tiotropium; Assigned to Arm(s): Tiotropium
D: Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Arm Label: MP-376 240 mg Twice Daily (BID); Type: EXPERIMENTAL; Interventions: Drug: MP-376 | Intervention Type: DRUG; Name: MP-376; Assigned to Arm(s): MP-376 240 mg Twice Daily (BID) | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo

Answer: D