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: FLOVENT™ DISKUS™ 100 mcg; Type: ACTIVE_COMPARATOR; Interventions: Drug: FLOVENT™ DISKUS™ 100 mcg BID | Arm Label: ADVAIR™ DISKUS™ 100/50 mcg; Type: EXPERIMENTAL; Interventions: Drug: ADVAIR™ DISKUS™ 100/50 mcg BID | Intervention Type: DRUG; Name: FLOVENT™ DISKUS™ 100 mcg BID; Assigned to Arm(s): FLOVENT™ DISKUS™ 100 mcg | Intervention Type: DRUG; Name: ADVAIR™ DISKUS™ 100/50 mcg BID; Assigned to Arm(s): ADVAIR™ DISKUS™ 100/50 mcg
B: Arm Label: Fluticasone; Type: ACTIVE_COMPARATOR; Interventions: Drug: fluticasone, Drug: montelukast, Drug: Fluticasone plus salmeterol | Arm Label: Montelukast; Type: EXPERIMENTAL; Interventions: Drug: fluticasone, Drug: montelukast, Drug: Fluticasone plus salmeterol | Arm Label: Fluticasone plus salmeterol; Type: EXPERIMENTAL; Interventions: Drug: fluticasone, Drug: montelukast, Drug: Fluticasone plus salmeterol | Intervention Type: DRUG; Name: fluticasone; Assigned to Arm(s): Fluticasone, Fluticasone plus salmeterol, Montelukast | Intervention Type: DRUG; Name: montelukast; Assigned to Arm(s): Fluticasone, Fluticasone plus salmeterol, Montelukast | Intervention Type: DRUG; Name: Fluticasone plus salmeterol; Assigned to Arm(s): Fluticasone, Fluticasone plus salmeterol, Montelukast
C: 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
D: Arm Label: Fp MDPI 100 mcg; Type: EXPERIMENTAL; Interventions: Drug: Fp MDPI, Drug: albuterol/salbutamol HFA | Arm Label: FLOVENT HFA 110 mcg; Type: ACTIVE_COMPARATOR; Interventions: Drug: FLOVENT HFA, Drug: albuterol/salbutamol HFA | Arm Label: Fp MDPI 200 mcg; Type: EXPERIMENTAL; Interventions: Drug: Fp MDPI, Drug: albuterol/salbutamol HFA | Arm Label: FLOVENT HFA 220 mcg; Type: ACTIVE_COMPARATOR; Interventions: Drug: FLOVENT HFA, Drug: albuterol/salbutamol HFA | Arm Label: FS MDPI 100/12.5 mcg; Type: EXPERIMENTAL; Interventions: Drug: FS MDPI, Drug: albuterol/salbutamol HFA | Arm Label: ADVAIR DISKUS 250/50 mcg; Type: ACTIVE_COMPARATOR; Interventions: Drug: ADVAIR DISKUS, Drug: albuterol/salbutamol HFA | Arm Label: FS MDPI 200/12.5 mcg; Type: EXPERIMENTAL; Interventions: Drug: FS MDPI, Drug: albuterol/salbutamol HFA | Arm Label: ADVAIR DISKUS 500/50 mcg; Type: ACTIVE_COMPARATOR; Interventions: Drug: ADVAIR DISKUS, Drug: albuterol/salbutamol HFA | Intervention Type: DRUG; Name: Fp MDPI; Assigned to Arm(s): Fp MDPI 100 mcg, Fp MDPI 200 mcg | Intervention Type: DRUG; Name: FS MDPI; Assigned to Arm(s): FS MDPI 100/12.5 mcg, FS MDPI 200/12.5 mcg | Intervention Type: DRUG; Name: FLOVENT HFA; Assigned to Arm(s): FLOVENT HFA 110 mcg, FLOVENT HFA 220 mcg | Intervention Type: DRUG; Name: ADVAIR DISKUS; Assigned to Arm(s): ADVAIR DISKUS 250/50 mcg, ADVAIR DISKUS 500/50 mcg | Intervention Type: DRUG; Name: albuterol/salbutamol HFA; Assigned to Arm(s): ADVAIR DISKUS 250/50 mcg, ADVAIR DISKUS 500/50 mcg, FLOVENT HFA 110 mcg, FLOVENT HFA 220 mcg, FS MDPI 100/12.5 mcg, FS MDPI 200/12.5 mcg, Fp MDPI 100 mcg, Fp MDPI 200 mcg

Answer: C