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 (5 mcg/Day) Over 48 Weeks as add-on Controller Therapy on Top of Usual Care in Patients With Severe Persistent Asthma
Brief Summary: The trial is a randomised, double-blind, placebo-controlled, parallel-group trial to evaluate the efficacy and safety of 5 µg tiotropium over a 48-week treatment period as compared to placebo. Tiotropium inhalation solution delivered by the Respimat® inhaler will be examined as add-on controller therapy on top of usual care in patients with severe persistent asthma. The primary objective of each trial is to evaluate the long term efficacy of tiotropium over placebo on top of usual care in patients with severe persistent asthma as determined by pulmonary function testing, effects on asthma exacerbations, effects on quality of life, on asthma control and health care resource utilisation. The secondary objective of each trial is to compare the long term safety of tiotropium with placebo in this patient population.


Options:
A: 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
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 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: D