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 Safety and Efficacy of Tiotropium Inhalation Solution Delivered Via Respimat Inhaler (2.5 and 5 µg Once Daily) Compared With Placebo Over 52 Weeks in Patients With Moderate to Severe Persistent Asthma
Brief Summary: The aim of this trial is to evaluate the safety and efficacy of 2.5 and 5 µg tiotropium over a 52-week treatment period as compared to placebo. 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 to severe persistent asthma. Efficacy and safety will be assessed by measuring effects on lung function, effects on asthma exacerbations, effects on asthma control, 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: 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
C: Arm Label: tiotropium low dose once daily; Type: EXPERIMENTAL; Interventions: Drug: tiotropium bromide 1.25µg once daily | Arm Label: tiotropium medium dose once daily; Type: EXPERIMENTAL; Interventions: Drug: tiotropium bromide 2.5µg once daily | Arm Label: tiotropium high dose once daily; Type: EXPERIMENTAL; Interventions: Drug: tiotropium bromide high dose once daily | Arm Label: Placebo once daily; Type: PLACEBO_COMPARATOR; Interventions: Drug: Tiotropium matching Placebo once daily | Intervention Type: DRUG; Name: tiotropium bromide 2.5µg once daily; Assigned to Arm(s): tiotropium medium dose once daily | Intervention Type: DRUG; Name: Tiotropium matching Placebo once daily; Assigned to Arm(s): Placebo once daily | Intervention Type: DRUG; Name: tiotropium bromide high dose once daily; Assigned to Arm(s): tiotropium high dose once daily | Intervention Type: DRUG; Name: tiotropium bromide 1.25µg once daily; Assigned to Arm(s): tiotropium low dose once daily
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: Placebo, Drug: tiotropium Respimat® high dose | Arm Label: 50 mcg salmeterol; Type: ACTIVE_COMPARATOR; Interventions: Drug: 50 mcg salmeterol HFA MDI, Drug: Placebo | Arm Label: placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): tiotropium low dose | Intervention Type: DRUG; Name: tiotropium Respimat® low dose; Assigned to Arm(s): tiotropium low dose | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): placebo | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): tiotropium high dose | 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): placebo | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): 50 mcg salmeterol

Answer: A