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 Trial to Evaluate Efficacy and Safety of Tiotropium Inhalation Solution Delivered Via Respimat® Inhaler (5 mcg/Day) Over 48 Weeks as add-on Controller Therapy on Top of Usual Care in Patients With Severe Persistent Asthma
Brief Summary: The trial is a randomised, double-blind, placebo-controlled, parallel-group trial to evaluate the efficacy and safety of 5 µg tiotropium over a 48-week treatment period as compared to placebo. Tiotropium inhalation solution delivered by the Respimat® inhaler will be examined as add-on controller therapy on top of usual care in patients with severe persistent asthma. The primary objective of each trial is to evaluate the long term efficacy of tiotropium over placebo on top of usual care in patients with severe persistent asthma as determined by pulmonary function testing, effects on asthma exacerbations, effects on quality of life, on asthma control and health care resource utilisation. The secondary objective of each trial is to compare the long term safety of tiotropium with placebo in this patient population.


Options:
A: Arm Label: QMF149 Twisthaler® 500/400; Type: EXPERIMENTAL; Interventions: Drug: QMF149 Twisthaler® | Arm Label: Mometasone Twisthaler®; Type: ACTIVE_COMPARATOR; Interventions: Drug: Mometasone Twisthaler® | Intervention Type: DRUG; Name: QMF149 Twisthaler®; Assigned to Arm(s): QMF149 Twisthaler® 500/400 | Intervention Type: DRUG; Name: Mometasone Twisthaler®; Assigned to Arm(s): Mometasone Twisthaler®
B: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Drug: FlutiForm 250/10 | Arm Label: 2; Type: ACTIVE_COMPARATOR; Interventions: Drug: SKP-Fluticasone | Arm Label: 3; Type: ACTIVE_COMPARATOR; Interventions: Drug: Flovent Fluticasone HFA | Intervention Type: DRUG; Name: FlutiForm 250/10; Assigned to Arm(s): 1 | Intervention Type: DRUG; Name: SKP-Fluticasone; Assigned to Arm(s): 2 | Intervention Type: DRUG; Name: Flovent Fluticasone HFA; Assigned to Arm(s): 3
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: Fluticasone furoate/Vilanterol (GW642444); Type: EXPERIMENTAL; Interventions: Drug: Fluticasone furoate/Vilanterol Inhalation Powder, Drug: Placebo (2) | Arm Label: Fluticasone propionate/salmeterol; Type: ACTIVE_COMPARATOR; Interventions: Drug: Fluticasone propionate/salmeterol Inhalation Powder, Drug: Placebo (1) | Intervention Type: DRUG; Name: Fluticasone furoate/Vilanterol Inhalation Powder; Assigned to Arm(s): Fluticasone furoate/Vilanterol (GW642444) | Intervention Type: DRUG; Name: Fluticasone propionate/salmeterol Inhalation Powder; Assigned to Arm(s): Fluticasone propionate/salmeterol | Intervention Type: DRUG; Name: Placebo (1); Assigned to Arm(s): Fluticasone propionate/salmeterol | Intervention Type: DRUG; Name: Placebo (2); Assigned to Arm(s): Fluticasone furoate/Vilanterol (GW642444)

Answer: C