Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Randomized, Active-controlled, Double-blind, Double-dummy, Parallel Group Design, Multi-center Trial to Compare the Efficacy and Safety of 2.5 µg and 5 µg Tiotropium Inhalation Solution Delivered by the Respimat Inhaler With Tiotropium Inhalation Capsules 18 µg Delivered by the HandiHaler (TIOSPIR)
Brief Summary: Direct comparison studies of the tiotropium HandiHaler® 18 µg and Respimat® 5 µg formulations have been limited to 4-week crossover studies. Therefore, prospective data from a trial of adequate size and duration is required to establish that compared to tiotropium HandiHaler®, tiotropium Respimat® will have (a) similar effects on safety and (b) similar or superior effects on exacerbations.


Options:
A: Arm Label: UMEC/VI arm; Type: EXPERIMENTAL; Interventions: Drug: UMEC/VI, Drug: UMEC/VI matching placebo, Drug: Albuterol/salbutamol Metered Dose Inhaler (MDI) | Arm Label: Tiotropium + Indacaterol arm; Type: PLACEBO_COMPARATOR; Interventions: Drug: Tiotropium, Drug: Tiotropium matching placebo, Drug: Indacaterol, Drug: Indacaterol matching placebo, Drug: Albuterol/salbutamol Metered Dose Inhaler (MDI) | Intervention Type: DRUG; Name: UMEC/VI; Assigned to Arm(s): UMEC/VI arm | Intervention Type: DRUG; Name: UMEC/VI matching placebo; Assigned to Arm(s): UMEC/VI arm | Intervention Type: DRUG; Name: Tiotropium; Assigned to Arm(s): Tiotropium + Indacaterol arm | Intervention Type: DRUG; Name: Tiotropium matching placebo; Assigned to Arm(s): Tiotropium + Indacaterol arm | Intervention Type: DRUG; Name: Indacaterol; Assigned to Arm(s): Tiotropium + Indacaterol arm | Intervention Type: DRUG; Name: Indacaterol matching placebo; Assigned to Arm(s): Tiotropium + Indacaterol arm | Intervention Type: DRUG; Name: Albuterol/salbutamol Metered Dose Inhaler (MDI); Assigned to Arm(s): Tiotropium + Indacaterol arm, UMEC/VI arm
B: Arm Label: Fluticasone Furoate / GW642444 (vilanterol); Type: EXPERIMENTAL; Interventions: Drug: Fluticasone Furoate 100mcg/ GW642444 (vilanterol) 25mcg, Drug: Double-dummy placebo, Drug: Salbutamol as needed | Arm Label: Fluticasone Propionate / salmeterol; Type: ACTIVE_COMPARATOR; Interventions: Drug: Fluticasone Propionate 250mcg / salmeterol 50mcg, Drug: Double-dummy placebo, Drug: Salbutamol as needed | Intervention Type: DRUG; Name: Fluticasone Furoate 100mcg/ GW642444 (vilanterol) 25mcg; Assigned to Arm(s): Fluticasone Furoate / GW642444 (vilanterol) | Intervention Type: DRUG; Name: Fluticasone Propionate 250mcg / salmeterol 50mcg; Assigned to Arm(s): Fluticasone Propionate / salmeterol | Intervention Type: DRUG; Name: Double-dummy placebo; Assigned to Arm(s): Fluticasone Furoate / GW642444 (vilanterol), Fluticasone Propionate / salmeterol | Intervention Type: DRUG; Name: Salbutamol as needed; Assigned to Arm(s): Fluticasone Furoate / GW642444 (vilanterol), Fluticasone Propionate / salmeterol
C: Arm Label: tiotropium 2.5 mcg and placebo; Type: EXPERIMENTAL; Interventions: Drug: tiotropium 1.25 mcg (2 actuations/day) | Arm Label: tiotropium 18 mcg and placebo; Type: ACTIVE_COMPARATOR; Interventions: Drug: tiotropium 18 mcg | Arm Label: tiotropium 5 mcg and placebo; Type: EXPERIMENTAL; Interventions: Drug: tiotropium 2.5 mcg (2 actuations/day) | Intervention Type: DRUG; Name: tiotropium 18 mcg; Assigned to Arm(s): tiotropium 18 mcg and placebo | Intervention Type: DRUG; Name: tiotropium 1.25 mcg (2 actuations/day); Assigned to Arm(s): tiotropium 2.5 mcg and placebo | Intervention Type: DRUG; Name: tiotropium 2.5 mcg (2 actuations/day); Assigned to Arm(s): tiotropium 5 mcg and placebo
D: Arm Label: Glycopyrronium bromide 50 μg; Type: EXPERIMENTAL; Interventions: Drug: Glycopyrronium bromide | Arm Label: Placebo to glycopyrronium bromide; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo to glycopyrronium bromide | Arm Label: Tiotropium 18 μg; Type: ACTIVE_COMPARATOR; Interventions: Drug: Tiotropium | Intervention Type: DRUG; Name: Glycopyrronium bromide; Assigned to Arm(s): Glycopyrronium bromide 50 μg | Intervention Type: DRUG; Name: Placebo to glycopyrronium bromide; Assigned to Arm(s): Placebo to glycopyrronium bromide | Intervention Type: DRUG; Name: Tiotropium; Assigned to Arm(s): Tiotropium 18 μg

Answer: C