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 Study to Assess the Efficacy and Safety Over 48 Weeks of Orally Inhaled Tiotropium Bromide (2.5 and 5 µg Once Daily ) Delivered by the Respimat® Inhaler in Adolescents (12 to 17 Years Old) With Moderate Persistent Asthma.
Brief Summary: The aim of the study is to evaluate efficacy and safety of a 48-week treatment with two doses of tiotropium bromide compared to placebo in adolescent patients with moderate persistent asthma. Efficacy and safety will be assessed by measuring lung function parameters and evaluating the effects on asthma exacerbations, on Quality of life, on health care resource utilisation an on the number of adverse events.


Options:
A: Arm Label: tiotropium 5 mcg; Type: EXPERIMENTAL; Interventions: Drug: tiotropium 5 mcg | Arm Label: tiotropium 2.5 mcg; Type: EXPERIMENTAL; Interventions: Drug: tiotropium 2.5 mcg | Arm Label: placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: placebo | Intervention Type: DRUG; Name: placebo; Assigned to Arm(s): placebo | Intervention Type: DRUG; Name: tiotropium 2.5 mcg; Assigned to Arm(s): tiotropium 2.5 mcg | Intervention Type: DRUG; Name: tiotropium 5 mcg; Assigned to Arm(s): tiotropium 5 mcg
B: Arm Label: placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: placebo Respimat | Arm Label: tiotropium low dose; Type: EXPERIMENTAL; Interventions: Drug: tiotropium Respimat low dose | Arm Label: tiotropium high dose; Type: EXPERIMENTAL; Interventions: Drug: tiotropium Respimat high dose | Intervention Type: DRUG; Name: tiotropium Respimat low dose; Assigned to Arm(s): tiotropium low dose | Intervention Type: DRUG; Name: placebo Respimat; Assigned to Arm(s): placebo | Intervention Type: DRUG; Name: tiotropium Respimat high dose; Assigned to Arm(s): tiotropium high dose
C: Arm Label: BDP 320 mcg BAI; Type: EXPERIMENTAL; Interventions: Drug: Beclomethasone dipropionate, Drug: Placebo, Drug: Albuterol/salbutamol | Arm Label: BDP 640 mcg BAI; Type: EXPERIMENTAL; Interventions: Drug: Beclomethasone dipropionate, Drug: Placebo, Drug: Albuterol/salbutamol | Arm Label: BDP 320 mcg MDI; Type: ACTIVE_COMPARATOR; Interventions: Drug: Beclomethasone dipropionate, Drug: Placebo, Drug: Albuterol/salbutamol | Arm Label: BDP 640 mcg MDI; Type: ACTIVE_COMPARATOR; Interventions: Drug: Beclomethasone dipropionate, Drug: Placebo, Drug: Albuterol/salbutamol | Arm Label: Placebo BAI and MDI; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo, Drug: Albuterol/salbutamol | Intervention Type: DRUG; Name: Beclomethasone dipropionate; Assigned to Arm(s): BDP 320 mcg BAI, BDP 320 mcg MDI, BDP 640 mcg BAI, BDP 640 mcg MDI | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): BDP 320 mcg BAI, BDP 320 mcg MDI, BDP 640 mcg BAI, BDP 640 mcg MDI, Placebo BAI and MDI | Intervention Type: DRUG; Name: Albuterol/salbutamol; Assigned to Arm(s): BDP 320 mcg BAI, BDP 320 mcg MDI, BDP 640 mcg BAI, BDP 640 mcg MDI, Placebo BAI and MDI
D: Arm Label: Symbicort; Type: ACTIVE_COMPARATOR; Interventions: Drug: Budesonide/formoterol (SYMBICORT) pMDI | Arm Label: Budesonide; Type: ACTIVE_COMPARATOR; Interventions: Drug: Budesonide HFA pMDI | Intervention Type: DRUG; Name: Budesonide/formoterol (SYMBICORT) pMDI; Assigned to Arm(s): Symbicort | Intervention Type: DRUG; Name: Budesonide HFA pMDI; Assigned to Arm(s): Budesonide

Answer: B