Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Phase III Randomised, Double-blind, Placebo-controlled, Parallel-group Trial to Evaluate Efficacy and Safety of Tiotropium Inhalation Solution Delivered Via Respimat® Inhaler (2.5 and 5 µg Once Daily) Compared With Placebo and Salmeterol HFA MDI (50 µg Twice Daily) Over 24 Weeks in Moderate Persistent Asthma
Brief Summary: The aim of this trial is to evaluate the efficacy and safety of 2.5 and 5 mcg tiotropium over a 24-week treatment period as compared to placebo and salmeterol (50 mcg twice daily). Tiotropium inhalation solution delivered by the Respimat® inhaler will be examined on top of maintenance treatment with inhaled corticosteroid controller medication in patients with moderate persistent asthma. Efficacy and safety will be assessed by measuring effects on lung function, effects on asthma exacerbations, effects on quality of life, effects on asthma control, effects on health care resource utilisation, and number of adverse events.


Options:
A: Arm Label: Tiotropium Respimat (low dose); Type: EXPERIMENTAL; Interventions: Drug: Tiotropium Respimat | Arm Label: Tiotropium Respimat (high dose); Type: EXPERIMENTAL; Interventions: Drug: Tiotropium Respimat | Arm Label: Placebo Respimat; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo Respimat | Intervention Type: DRUG; Name: Tiotropium Respimat; Assigned to Arm(s): Tiotropium Respimat (high dose) | Intervention Type: DRUG; Name: Placebo Respimat; Assigned to Arm(s): Placebo Respimat | Intervention Type: DRUG; Name: Tiotropium Respimat; Assigned to Arm(s): Tiotropium Respimat (low dose)
B: 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
C: 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
D: Arm Label: tiotropium low dose; Type: EXPERIMENTAL; Interventions: Drug: placebo, Drug: tiotropium Respimat® low dose | Arm Label: tiotropium high dose; Type: EXPERIMENTAL; Interventions: Drug: tiotropium Respimat® high dose, Drug: placebo | Arm Label: 50 mcg salmeterol; Type: ACTIVE_COMPARATOR; Interventions: Drug: placebo, Drug: 50 mcg salmeterol HFA MDI | Arm Label: placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: placebo | Intervention Type: DRUG; Name: placebo; Assigned to Arm(s): placebo | Intervention Type: DRUG; Name: placebo; Assigned to Arm(s): tiotropium low dose | Intervention Type: DRUG; Name: placebo; Assigned to Arm(s): placebo | Intervention Type: DRUG; Name: tiotropium Respimat® low dose; Assigned to Arm(s): tiotropium low dose | Intervention Type: DRUG; Name: placebo; Assigned to Arm(s): 50 mcg salmeterol | Intervention Type: DRUG; Name: tiotropium Respimat® high dose; Assigned to Arm(s): tiotropium high dose | Intervention Type: DRUG; Name: 50 mcg salmeterol HFA MDI; Assigned to Arm(s): 50 mcg salmeterol | Intervention Type: DRUG; Name: placebo; Assigned to Arm(s): tiotropium high dose

Answer: D