Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Randomized, Active-controlled, Double-blind, Double-dummy, Parallel Group Design, Multi-center Trial to Compare the Efficacy and Safety of 2.5 µg and 5 µg Tiotropium Inhalation Solution Delivered by the Respimat Inhaler With Tiotropium Inhalation Capsules 18 µg Delivered by the HandiHaler (TIOSPIR)
Brief Summary: Direct comparison studies of the tiotropium HandiHaler® 18 µg and Respimat® 5 µg formulations have been limited to 4-week crossover studies. Therefore, prospective data from a trial of adequate size and duration is required to establish that compared to tiotropium HandiHaler®, tiotropium Respimat® will have (a) similar effects on safety and (b) similar or superior effects on exacerbations.


Options:
A: Intervention Type: DRUG; Name: Tiotropium bromide; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: Salmeterol xinafoate; Assigned to Arm(s): N/A
B: Arm Label: tiotropium 2.5 mcg and placebo; Type: EXPERIMENTAL; Interventions: Drug: tiotropium 1.25 mcg (2 actuations/day) | Arm Label: tiotropium 18 mcg and placebo; Type: ACTIVE_COMPARATOR; Interventions: Drug: tiotropium 18 mcg | Arm Label: tiotropium 5 mcg and placebo; Type: EXPERIMENTAL; Interventions: Drug: tiotropium 2.5 mcg (2 actuations/day) | Intervention Type: DRUG; Name: tiotropium 18 mcg; Assigned to Arm(s): tiotropium 18 mcg and placebo | Intervention Type: DRUG; Name: tiotropium 1.25 mcg (2 actuations/day); Assigned to Arm(s): tiotropium 2.5 mcg and placebo | Intervention Type: DRUG; Name: tiotropium 2.5 mcg (2 actuations/day); Assigned to Arm(s): tiotropium 5 mcg and placebo
C: Arm Label: Tio + 1xICS || LABA + 1xICS || 2xICS; Type: EXPERIMENTAL; Interventions: Drug: tiotropium bromide, Drug: salmeterol xinafoate, Drug: beclomethasone dipropionate | Arm Label: TIO + 1xICS || 2xICS || LABA + 1xICS; Type: EXPERIMENTAL; Interventions: Drug: tiotropium bromide, Drug: salmeterol xinafoate, Drug: beclomethasone dipropionate | Arm Label: LABA + 1xICS || Tio + 1xICS || 2xICS; Type: EXPERIMENTAL; Interventions: Drug: tiotropium bromide, Drug: salmeterol xinafoate, Drug: beclomethasone dipropionate | Arm Label: LABA + 1xICS || 2xICS || Tio + 1xICS; Type: EXPERIMENTAL; Interventions: Drug: tiotropium bromide, Drug: salmeterol xinafoate, Drug: beclomethasone dipropionate | Arm Label: 2xICS || Tio + 1xICS| || LABA + 1xICS; Type: EXPERIMENTAL; Interventions: Drug: tiotropium bromide, Drug: salmeterol xinafoate, Drug: beclomethasone dipropionate | Arm Label: 2xICS || LABA + 1xICS || Tio + 1xICS; Type: EXPERIMENTAL; Interventions: Drug: tiotropium bromide, Drug: salmeterol xinafoate, Drug: beclomethasone dipropionate | Intervention Type: DRUG; Name: tiotropium bromide; Assigned to Arm(s): 2xICS || LABA + 1xICS || Tio + 1xICS, 2xICS || Tio + 1xICS| || LABA + 1xICS, LABA + 1xICS || 2xICS || Tio + 1xICS, LABA + 1xICS || Tio + 1xICS || 2xICS, TIO + 1xICS || 2xICS || LABA + 1xICS, Tio + 1xICS || LABA + 1xICS || 2xICS | Intervention Type: DRUG; Name: salmeterol xinafoate; Assigned to Arm(s): 2xICS || LABA + 1xICS || Tio + 1xICS, 2xICS || Tio + 1xICS| || LABA + 1xICS, LABA + 1xICS || 2xICS || Tio + 1xICS, LABA + 1xICS || Tio + 1xICS || 2xICS, TIO + 1xICS || 2xICS || LABA + 1xICS, Tio + 1xICS || LABA + 1xICS || 2xICS | Intervention Type: DRUG; Name: beclomethasone dipropionate; Assigned to Arm(s): 2xICS || LABA + 1xICS || Tio + 1xICS, 2xICS || Tio + 1xICS| || LABA + 1xICS, LABA + 1xICS || 2xICS || Tio + 1xICS, LABA + 1xICS || Tio + 1xICS || 2xICS, TIO + 1xICS || 2xICS || LABA + 1xICS, Tio + 1xICS || LABA + 1xICS || 2xICS
D: Arm Label: tiotropium 5mcg/day; Type: EXPERIMENTAL; Interventions: Drug: tiotropium 5mcg/day | Arm Label: placebo; Type: EXPERIMENTAL; Interventions: Drug: placebo | Intervention Type: DRUG; Name: tiotropium 5mcg/day; Assigned to Arm(s): tiotropium 5mcg/day | Intervention Type: DRUG; Name: placebo; Assigned to Arm(s): placebo

Answer: B