Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Phase II, Randomised, Double- Blind, Placebo Controlled, Cross-over Efficacy and Safety Comparison of Tiotropium 5 µg Administered Once Daily (in the Evening) and Tiotropium 2.5 µg Administered Twice Daily Delivered by the Respimat® Inhaler for Four Weeks Versus Placebo in Patients With Moderate Persistent Asthma
Brief Summary: Rationale for the current trial is to demonstrate 24 hour bronchodilator efficacy and safety of tiotropium 5 µg administered once daily (in the evening) which is regarded beneficial for the compliance and convenience of the patient in comparison to placebo. Further the rationale is to evaluate efficacy and safety of tiotropium 2.5 µg administered twice daily delivered by the Respimat® inhaler in comparison to placebo and tiotropium 5 µg administered once daily (in the evening) delivered by the Respimat® inhaler in patients with moderate persistent asthma.

Rationale for the pharmacokinetic subinvestigation is to evaluate the 24 hours exposure to tiotropium in patients with moderate persistent asthma when administered 5 µg tiotropium once daily (in the evening) or 2.5 µg tiotropium twice daily.


Options:
A: 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
B: 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
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 daily dose q.d.; Type: EXPERIMENTAL; Interventions: Drug: Tiotropium 5 µg q.d. | Arm Label: Tiotropium half daily dose b.i.d.; Type: EXPERIMENTAL; Interventions: Drug: Tiotropium 2.5 µg b.i.d | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Tiotropium 2.5 µg b.i.d; Assigned to Arm(s): Tiotropium half daily dose b.i.d. | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo | Intervention Type: DRUG; Name: Tiotropium 5 µg q.d.; Assigned to Arm(s): Tiotropium daily dose q.d.

Answer: D