Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Randomised, Double-blind, Placebo-controlled, Parallel-group Trial to Evaluate Efficacy and Safety of Tiotropium Inhalation Solution Delivered Via Respimat® Inhaler (2.5 mcg and 5 mcg Once Daily) Over 12 Weeks as add-on Controller Therapy on Top of Usual Care in Adolescents (12 to 17 Years Old) With Severe Persistent Asthma
Brief Summary: The overall purpose of the trial is to evaluate efficacy and safety of tiotropium inhalation solution delivered via Respimat® inhaler (2.5 mcg and 5 mcg once daily) over 12 weeks, compared to placebo, as add-on controller therapy on top of usual care in adolescents (12 to 17 years old) with severe persistent asthma.

The primary objective of the trial is to demonstrate superiority of tiotropium (5 mcg and possibly 2.5 mcg once daily in the evening) over placebo with regard to the primary pulmonary function endpoint after 12 weeks of treatment.

Secondary objectives are to evaluate efficacy of tiotropium with regard to other endpoints, and to evaluate the safety of tiotropium, compared to placebo, as add-on controller therapy on top of usual care in this patient population.


Options:
A: 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
B: Arm Label: Symbicort; Type: EXPERIMENTAL; Interventions: Drug: Budesonide/formoterol (SYMBICORT) pMDI | Arm Label: Budesonide; Type: EXPERIMENTAL; 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
C: 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
D: Arm Label: A; Type: EXPERIMENTAL; Interventions: Drug: tiotropium low dose | Arm Label: B; Type: EXPERIMENTAL; Interventions: Drug: tiotropium high dose | Arm Label: C; Type: PLACEBO_COMPARATOR; Interventions: Drug: placebo | Intervention Type: DRUG; Name: tiotropium high dose; Assigned to Arm(s): B | Intervention Type: DRUG; Name: placebo; Assigned to Arm(s): C | Intervention Type: DRUG; Name: tiotropium low dose; Assigned to Arm(s): A

Answer: D