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 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
B: 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
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; Type: EXPERIMENTAL; Interventions: Drug: Tiotropium | Arm Label: Salmeterol or Formoterol; Type: ACTIVE_COMPARATOR; Interventions: Drug: Salmeterol, Drug: Formoterol | Intervention Type: DRUG; Name: Tiotropium; Assigned to Arm(s): Tiotropium | Intervention Type: DRUG; Name: Salmeterol; Assigned to Arm(s): Salmeterol or Formoterol | Intervention Type: DRUG; Name: Formoterol; Assigned to Arm(s): Salmeterol or Formoterol

Answer: B