Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A 52-week Treatment, Multicenter, Randomized, Double-blind, Double-dummy, Placebo-controlled, Parallel-group Study to Assess the Efficacy, Safety, and Tolerability of Indacaterol (300 and 600 µg Once Daily) in Patients With Chronic Obstructive Pulmonary Disease, Using Formoterol (12 µg Twice Daily) as an Active Control
Brief Summary: This study was designed to assess the efficacy and long-term safety of 300 and 600 µg doses of indacaterol when delivered via a single-dose dry-powder inhaler (SDDPI) in patients with chronic obstructive pulmonary disease (COPD). Patients were randomized to receive either indacaterol 300 µg once daily, indacaterol 600 µg once daily, formoterol 12 µg twice daily, or placebo.


Options:
A: Arm Label: Indacaterol 150 μg; Type: EXPERIMENTAL; Interventions: Drug: Indacaterol 150 µg | Arm Label: Indacaterol 300 μg; Type: EXPERIMENTAL; Interventions: Drug: Indacaterol 300 μg | Arm Label: Placebo to indacaterol; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo to indacaterol | Intervention Type: DRUG; Name: Indacaterol 150 µg; Assigned to Arm(s): Indacaterol 150 μg | Intervention Type: DRUG; Name: Indacaterol 300 μg; Assigned to Arm(s): Indacaterol 300 μg | Intervention Type: DRUG; Name: Placebo to indacaterol; Assigned to Arm(s): Placebo to indacaterol
B: Arm Label: Indacaterol 300 μg plus placebo to formoterol; Type: EXPERIMENTAL; Interventions: Drug: Indacaterol, Drug: Placebo to formoterol | Arm Label: Indacaterol 600 μg plus placebo to formoterol; Type: EXPERIMENTAL; Interventions: Drug: Indacaterol, Drug: Placebo to formoterol | Arm Label: Formoterol 12 μg plus placebo to indacaterol; Type: ACTIVE_COMPARATOR; Interventions: Drug: Formoterol, Drug: Placebo to indacaterol | Arm Label: Placebo to indacaterol plus placebo to formoterol; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo to indacaterol, Drug: Placebo to formoterol | Intervention Type: DRUG; Name: Indacaterol; Assigned to Arm(s): Indacaterol 300 μg plus placebo to formoterol, Indacaterol 600 μg plus placebo to formoterol | Intervention Type: DRUG; Name: Formoterol; Assigned to Arm(s): Formoterol 12 μg plus placebo to indacaterol | Intervention Type: DRUG; Name: Placebo to indacaterol; Assigned to Arm(s): Formoterol 12 μg plus placebo to indacaterol, Placebo to indacaterol plus placebo to formoterol | Intervention Type: DRUG; Name: Placebo to formoterol; Assigned to Arm(s): Indacaterol 300 μg plus placebo to formoterol, Indacaterol 600 μg plus placebo to formoterol, Placebo to indacaterol plus placebo to formoterol
C: Arm Label: Indacaterol 150 µg; Type: EXPERIMENTAL; Interventions: Drug: Indacaterol 150 μg capsules | Arm Label: Indacaterol 300 µg; Type: EXPERIMENTAL; Interventions: Drug: Indacaterol 300 μg capsules | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo capsules | Intervention Type: DRUG; Name: Indacaterol 150 μg capsules; Assigned to Arm(s): Indacaterol 150 µg | Intervention Type: DRUG; Name: Indacaterol 300 μg capsules; Assigned to Arm(s): Indacaterol 300 µg | Intervention Type: DRUG; Name: Placebo capsules; Assigned to Arm(s): Placebo
D: Arm Label: Indacaterol 150 µg (Continued Into Stage 2); Type: EXPERIMENTAL; Interventions: Drug: Indacaterol, Drug: Placebo to Indacaterol, Drug: Placebo to Formoterol | Arm Label: Indacaterol 300 µg (Continued Into Stage 2); Type: EXPERIMENTAL; Interventions: Drug: Indacaterol, Drug: Placebo to Indacaterol, Drug: Placebo to Formoterol | Arm Label: Tiotropium 18 µg (Continued Into Stage 2); Type: ACTIVE_COMPARATOR; Interventions: Drug: Tiotropium (18 µg o.d.) | Arm Label: Placebo (Continued Into Stage 2); Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo to Indacaterol, Drug: Placebo to Formoterol | Arm Label: Indacaterol 75 µg (Not Continued into Stage 2); Type: EXPERIMENTAL; Interventions: Drug: Indacaterol, Drug: Placebo to Indacaterol, Drug: Placebo to Formoterol | Arm Label: Indacaterol 600 µg (Not Continued Into Stage 2); Type: EXPERIMENTAL; Interventions: Drug: Indacaterol, Drug: Placebo to Formoterol | Arm Label: Formoterol 12 µg (Not Continued Into Stage 2); Type: ACTIVE_COMPARATOR; Interventions: Drug: Formoterol (12 µg b.i.d.), Drug: Placebo to Indacaterol | Intervention Type: DRUG; Name: Indacaterol; Assigned to Arm(s): Indacaterol 150 µg (Continued Into Stage 2), Indacaterol 300 µg (Continued Into Stage 2), Indacaterol 600 µg (Not Continued Into Stage 2), Indacaterol 75 µg (Not Continued into Stage 2) | Intervention Type: DRUG; Name: Formoterol (12 µg b.i.d.); Assigned to Arm(s): Formoterol 12 µg (Not Continued Into Stage 2) | Intervention Type: DRUG; Name: Tiotropium (18 µg o.d.); Assigned to Arm(s): Tiotropium 18 µg (Continued Into Stage 2) | Intervention Type: DRUG; Name: Placebo to Indacaterol; Assigned to Arm(s): Formoterol 12 µg (Not Continued Into Stage 2), Indacaterol 150 µg (Continued Into Stage 2), Indacaterol 300 µg (Continued Into Stage 2), Indacaterol 75 µg (Not Continued into Stage 2), Placebo (Continued Into Stage 2) | Intervention Type: DRUG; Name: Placebo to Formoterol; Assigned to Arm(s): Indacaterol 150 µg (Continued Into Stage 2), Indacaterol 300 µg (Continued Into Stage 2), Indacaterol 600 µg (Not Continued Into Stage 2), Indacaterol 75 µg (Not Continued into Stage 2), Placebo (Continued Into Stage 2)

Answer: B