Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A 26-week Treatment, Multicenter, Randomized, Double Blind, Double Dummy, Placebo-controlled, Adaptive, Seamless, Parallel-group Study to Assess the Efficacy, Safety and Tolerability of Two Doses of Indacaterol (Selected From 75, 150, 300 & 600 µg o.d.) in Patients With Chronic Obstructive Pulmonary Disease Using Blinded Formoterol (12 µg b.i.d.) and Open Label Tiotropium (18 µg o.d.) as Active Controls
Brief Summary: Stage 1 of the study is designed to provide data about the risk-benefit of 4 dose regimens of indacaterol (75, 150, 300 \& 600 µg o.d.) in order to select two doses to carry forward into study Stage 2. Study Stage 2 will provide pivotal confirmation of efficacy, safety, and tolerability of the selected indacaterol doses in patients with COPD


Options:
A: Intervention Type: DRUG; Name: Salmeterol 50mcg/ Fluticasone Propionate 500mcg; Assigned to Arm(s): N/A
B: Arm Label: Arformoterol 15 mcg twice daily; Type: ACTIVE_COMPARATOR; Interventions: Drug: Arformoterol Tartrate Inhalation Solution, Drug: Placebo | Arm Label: Tiotropium 18 mcg once daily; Type: ACTIVE_COMPARATOR; Interventions: Drug: Tiotropium, Drug: Placebo | Arm Label: Arformoterol /Tiotropium; Type: EXPERIMENTAL; Interventions: Drug: Arformoterol and Tiotropium | Intervention Type: DRUG; Name: Arformoterol Tartrate Inhalation Solution; Assigned to Arm(s): Arformoterol 15 mcg twice daily | Intervention Type: DRUG; Name: Tiotropium; Assigned to Arm(s): Tiotropium 18 mcg once daily | Intervention Type: DRUG; Name: Arformoterol and Tiotropium; Assigned to Arm(s): Arformoterol /Tiotropium | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Arformoterol 15 mcg twice daily, Tiotropium 18 mcg once daily
C: 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)
D: Arm Label: Sequence 1: Placebo,Tiotropium, Indacaterol 150 μg; Type: EXPERIMENTAL; Interventions: Drug: Indacaterol, Drug: Tiotropium, Drug: Placebo | Arm Label: Sequence 2: Indacaterol 300 μg, Indacaterol 150 μg, Tiotropium; Type: EXPERIMENTAL; Interventions: Drug: Indacaterol, Drug: Tiotropium | Arm Label: Sequence 3: Indacaterol 150 μg, Indacaterol 300 μg, Placebo; Type: EXPERIMENTAL; Interventions: Drug: Indacaterol, Drug: Placebo | Arm Label: Sequence 4: Tiotropium, Placebo, Indacaterol 300 μg; Type: EXPERIMENTAL; Interventions: Drug: Indacaterol, Drug: Tiotropium, Drug: Placebo | Intervention Type: DRUG; Name: Indacaterol; Assigned to Arm(s): Sequence 1: Placebo,Tiotropium, Indacaterol 150 μg, Sequence 2: Indacaterol 300 μg, Indacaterol 150 μg, Tiotropium, Sequence 3: Indacaterol 150 μg, Indacaterol 300 μg, Placebo, Sequence 4: Tiotropium, Placebo, Indacaterol 300 μg | Intervention Type: DRUG; Name: Tiotropium; Assigned to Arm(s): Sequence 1: Placebo,Tiotropium, Indacaterol 150 μg, Sequence 2: Indacaterol 300 μg, Indacaterol 150 μg, Tiotropium, Sequence 4: Tiotropium, Placebo, Indacaterol 300 μg | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Sequence 1: Placebo,Tiotropium, Indacaterol 150 μg, Sequence 3: Indacaterol 150 μg, Indacaterol 300 μg, Placebo, Sequence 4: Tiotropium, Placebo, Indacaterol 300 μg

Answer: C