Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A 16-week Randomised, Placebo-controlled, Double-blind, Double-dummy, Parallel-group Study Comparing the Efficacy and Safety of Tiotropium Inhalation Solution Delivered by the Respimat Inhaler (2 Actuations of 2.5 Mcg Once Daily) With That of Salmeterol From the Hydrofluoroalkane Metered Dose Inhaler (2 Actuations of 25 Mcg Twice Daily) in Moderate Persistent Asthma Patients With the B16-Arg/Arg Genotype
Brief Summary: This is a 16 week multicentre, multinational, randomised, double-blind, double-dummy, placebo-controlled, parallel group study to evaluate the long-term efficacy and safety of tiotropium compared to salmeterol in moderate persistent asthmatic (GINA step 3) patients homozygous for arginine at the 16th amino acid position of the beta-adrenergic receptor (ADRB2). Following an initial 4-week run-in period on salmeterol MDI patients will be randomised into the 16 week double-blind treatment period in which they receive either tiotropium once daily administered from the Respimat inhaler or salmeterol twice daily administered from the hydrofluoro-alkane Metered Dose Inhaler (MDI), or placebo twice daily. After the 16 week treatment period all patients will receive salmeterol MDI twice daily for four weeks.

The patients perform daily morning and evening peak flow (PEF) and Forced Expiratory Volume in the First Second (FEV1) measurements with an electronic peak flow meter throughout the study. Daily data on asthma control and use of rescue medication are recorded using an electronic diary included in the electronic peak flow meter. On study visits the Mini-Asthma Quality of Life Questionnaire (Elizabeth Juniper) is administered, pulse and blood pressure and pre-dose pulmonary function testing (FEV1 and Forced Vital Capacity) are performed.


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: 1; Type: EXPERIMENTAL; Interventions: Drug: Fluticasone propionate/formoterol fumarate 100/10 | Arm Label: 2; Type: ACTIVE_COMPARATOR; Interventions: Drug: Fluticasone propionate 100 | Arm Label: 3; Type: ACTIVE_COMPARATOR; Interventions: Drug: Formoterol fumarate 10 | Arm Label: 4; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Fluticasone propionate/formoterol fumarate 100/10; Assigned to Arm(s): 1 | Intervention Type: DRUG; Name: Fluticasone propionate 100; Assigned to Arm(s): 2 | Intervention Type: DRUG; Name: Formoterol fumarate 10; Assigned to Arm(s): 3 | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): 4
D: Intervention Type: DRUG; Name: beclomethasone dipropionate plus formoterol fumarate combination; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: fluticasone propionate plus salmeterol xinafoate combination; Assigned to Arm(s): N/A

Answer: B