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: Mometasone Furoate/Formoterol MDI BID; Type: EXPERIMENTAL; Interventions: Drug: Mometasone Furoate/Formoterol MDI 100/5 mcg, Drug: Mometasone Furoate/Formoterol MDI 200/5 mcg, Drug: Albuterol 90 mcg /salbutamol 100 mcg HFA MDI, Drug: Prednisone/prednisolone | Arm Label: Mometasone Furoate MDI BID; Type: ACTIVE_COMPARATOR; Interventions: Drug: Mometasone Furoate MDI 100 mcg, Drug: Mometasone Furoate MDI 200 mcg, Drug: Albuterol 90 mcg /salbutamol 100 mcg HFA MDI, Drug: Prednisone/prednisolone | Intervention Type: DRUG; Name: Mometasone Furoate/Formoterol MDI 100/5 mcg; Assigned to Arm(s): Mometasone Furoate/Formoterol MDI BID | Intervention Type: DRUG; Name: Mometasone Furoate/Formoterol MDI 200/5 mcg; Assigned to Arm(s): Mometasone Furoate/Formoterol MDI BID | Intervention Type: DRUG; Name: Mometasone Furoate MDI 100 mcg; Assigned to Arm(s): Mometasone Furoate MDI BID | Intervention Type: DRUG; Name: Mometasone Furoate MDI 200 mcg; Assigned to Arm(s): Mometasone Furoate MDI BID | Intervention Type: DRUG; Name: Albuterol 90 mcg /salbutamol 100 mcg HFA MDI; Assigned to Arm(s): Mometasone Furoate MDI BID, Mometasone Furoate/Formoterol MDI BID | Intervention Type: DRUG; Name: Prednisone/prednisolone; Assigned to Arm(s): Mometasone Furoate MDI BID, Mometasone Furoate/Formoterol MDI BID
B: 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
C: Arm Label: Tiotropium; Type: EXPERIMENTAL; Interventions: Drug: Tiotropium | Arm Label: Salmeterol or Formoterol; Type: ACTIVE_COMPARATOR; Interventions: Drug: Salmeterol, Drug: Formoterol | Intervention Type: DRUG; Name: Tiotropium; Assigned to Arm(s): Tiotropium | Intervention Type: DRUG; Name: Salmeterol; Assigned to Arm(s): Salmeterol or Formoterol | Intervention Type: DRUG; Name: Formoterol; Assigned to Arm(s): Salmeterol or Formoterol
D: Arm Label: MF/F MDI 200/10 mcg BID; Type: EXPERIMENTAL; Interventions: Drug: mometasone furoate/formoterol fumarate combination MDI 200/10 mcg BID | Arm Label: MF MDI 200 mcg BID; Type: EXPERIMENTAL; Interventions: Drug: Mometasone furoate MDI (MF MDI) 200 mcg | Arm Label: F MDI 10 mcg BID; Type: EXPERIMENTAL; Interventions: Drug: formoterol fumarate 10 mcg | Arm Label: Placebo BID; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: mometasone furoate/formoterol fumarate combination MDI 200/10 mcg BID; Assigned to Arm(s): MF/F MDI 200/10 mcg BID | Intervention Type: DRUG; Name: Mometasone furoate MDI (MF MDI) 200 mcg; Assigned to Arm(s): MF MDI 200 mcg BID | Intervention Type: DRUG; Name: formoterol fumarate 10 mcg; Assigned to Arm(s): F MDI 10 mcg BID | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo BID

Answer: B