Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Phase III, Randomized, Double-blind, Placebo-Controlled Study Evaluating the Efficacy, Safety, and Tolerability of Two Fixed Dose Combinations of Aclidinium Bromide/Formoterol Fumarate Compared With Aclidinium Bromide, Formoterol Fumarate and Placebo for 24- 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 assess the maintenance bronchodilator effects of the fixed dose combination versus monotherapies. This study will also assess the effects of the fixed dose combination in terms of COPD symptoms, disease related health status and the long-term safety and tolerability of the fixed dose combination. This study will include a 24 week treatment period, preceding by a run-in period, followed by a two week follow up visit. All patients will be randomized to one of four treatment arms or placebo.


Options:
A: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Drug: Aclidinium Bromide/Formoterol Fumarate | Arm Label: 2; Type: EXPERIMENTAL; Interventions: Drug: Aclidinium Bromide/Formoterol Fumarate | 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 Fumarate; Assigned to Arm(s): 1 | Intervention Type: DRUG; Name: Aclidinium Bromide/Formoterol Fumarate; 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
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: COPD subjects; Type: N/A; Interventions: Other: Novel endpoint determination | Arm Label: Smoker controls; Type: N/A; Interventions: Other: Novel endpoint determination | Arm Label: Non-smoker controls; Type: N/A; Interventions: Other: Novel endpoint determination | Intervention Type: OTHER; Name: Novel endpoint determination; Assigned to Arm(s): COPD subjects, Non-smoker controls, Smoker controls
D: 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

Answer: A