Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Phase III, Long-term, Randomized, Double-blind, Extension Study of the Efficacy, Safety, and Tolerability of Two Fixed Dose Combinations of Aclidinium Bromide/Formoterol Fumarate, Aclidinium Bromide, Formoterol Fumarate and Placebo for 28- Weeks Treatment in Patients With Moderate to Severe, Stable Chronic Obstructive Pulmonary Disease (COPD)
Brief Summary: The purpose of this Phase III study is to evaluate the long-term safety and tolerability of two fixed-dose combinations of inhaled aclidinium bromide/formoterol fumarate, aclidinium bromide, formoterol fumarate and placebo in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD). Long-term efficacy, pharmacoeconomic and health-related quality of life assessments will also be evaluated. This extension study will include a 28 week treatment period, followed by a four week follow up visit. All patients will remain in the same treatment group as for the lead-in study and continue on one of the four treatment arms or placebo.


Options:
A: Arm Label: Aclidinium Bromide/Formoterol Fumarate FDC 400/12μg; Type: EXPERIMENTAL; Interventions: Drug: Aclidinium/Formoterol | Arm Label: Placebo to Aclidinium/Formoterol; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Aclidinium/Formoterol; Assigned to Arm(s): Aclidinium Bromide/Formoterol Fumarate FDC 400/12μg | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo to Aclidinium/Formoterol
B: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Drug: Aclidinium bromide/formoterol Fixed-Dose Combination (FDC) | Arm Label: 2; Type: EXPERIMENTAL; Interventions: Drug: Aclidinium bromide/formoterol Fixed-Dose Combination (FDC) | Arm Label: 3; Type: ACTIVE_COMPARATOR; Interventions: Drug: Aclidinium bromide | Arm Label: 4; Type: ACTIVE_COMPARATOR; Interventions: Drug: Formoterol Fumarate | Arm Label: 5; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Aclidinium bromide/formoterol Fixed-Dose Combination (FDC); Assigned to Arm(s): 1 | Intervention Type: DRUG; Name: Aclidinium bromide/formoterol Fixed-Dose Combination (FDC); Assigned to Arm(s): 2 | Intervention Type: DRUG; Name: Aclidinium bromide; Assigned to Arm(s): 3 | Intervention Type: DRUG; Name: Formoterol Fumarate; Assigned to Arm(s): 4 | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): 5
C: Arm Label: Aclidinium Bromide / Formoterol Fumarate; Type: EXPERIMENTAL; Interventions: Drug: Aclidinium Bromide / Formoterol Fumarate | Arm Label: Salmeterol / Fluticasone propionate; Type: ACTIVE_COMPARATOR; Interventions: Drug: Salmeterol / Fluticasone | Intervention Type: DRUG; Name: Aclidinium Bromide / Formoterol Fumarate; Assigned to Arm(s): Aclidinium Bromide / Formoterol Fumarate | Intervention Type: DRUG; Name: Salmeterol / Fluticasone; Assigned to Arm(s): Salmeterol / Fluticasone propionate
D: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Drug: Aclidinium Bromide/Formoterol Fumarate | Arm Label: 2; Type: ACTIVE_COMPARATOR; Interventions: Drug: Formoterol Fumarate | Intervention Type: DRUG; Name: Aclidinium Bromide/Formoterol Fumarate; Assigned to Arm(s): 1 | Intervention Type: DRUG; Name: Formoterol Fumarate; Assigned to Arm(s): 2

Answer: B