Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Randomised, Double-blinded, Active-controlled 2-way Cross Over Trial to Assess the Effects of 6 Weeks Treatment of Once Daily Orally Inhaled Tiotropium + Olodaterol Fixed Dose Combination Delivered by RESPIMAT Inhaler Compared With Tiotropium Delivered by RESPIMAT Inhaler on Lung Hyperinflation, Exercise Capacity and Physical Activity in Japanese Patients With Chronic Obstructive Pulmonary Disease (COPD)
Brief Summary: This is a multi-centre, randomised, double-blinded, active-controlled, 2-way cross over trial to assess the effects of once daily administration of orally inhaled tiotropium + olodaterol FDC or tiotropium (both delivered by the RESPIMAT Inhaler) on pulmonary function (lung hyperinflation), exercise capacity (6-minute walk distance) and physical activities after 6 weeks of treatment in Japanese patients with Chronic Obstructive Pulmonary Disease.


Options:
A: Arm Label: tiotropium+olodaterol high dose FDC; Type: EXPERIMENTAL; Interventions: Drug: tiotropium + olodaterol, Device: Respimat | Arm Label: tiotropium+olodaterol low dose FDC; Type: EXPERIMENTAL; Interventions: Drug: tiotropium + olodaterol, Device: Respimat | Arm Label: olodaterol; Type: ACTIVE_COMPARATOR; Interventions: Drug: olodaterol, Device: Respimat | Arm Label: tiotropium low dose; Type: ACTIVE_COMPARATOR; Interventions: Drug: tiotropium, Device: Respimat | Arm Label: tiotropium high dose; Type: ACTIVE_COMPARATOR; Interventions: Drug: tiotropium, Device: Respimat | Intervention Type: DRUG; Name: tiotropium + olodaterol; Assigned to Arm(s): tiotropium+olodaterol low dose FDC | Intervention Type: DRUG; Name: tiotropium + olodaterol; Assigned to Arm(s): tiotropium+olodaterol high dose FDC | Intervention Type: DRUG; Name: tiotropium; Assigned to Arm(s): tiotropium low dose | Intervention Type: DRUG; Name: tiotropium; Assigned to Arm(s): tiotropium high dose | Intervention Type: DRUG; Name: olodaterol; Assigned to Arm(s): olodaterol | Intervention Type: DEVICE; Name: Respimat; Assigned to Arm(s): olodaterol, tiotropium high dose, tiotropium low dose, tiotropium+olodaterol high dose FDC, tiotropium+olodaterol low dose FDC
B: Arm Label: tiotropium + olodaterol; Type: EXPERIMENTAL; Interventions: Drug: tiotropium, Drug: olodaterol | Arm Label: tiotropium; Type: ACTIVE_COMPARATOR; Interventions: Drug: tiotropium | Intervention Type: DRUG; Name: tiotropium; Assigned to Arm(s): tiotropium + olodaterol | Intervention Type: DRUG; Name: olodaterol; Assigned to Arm(s): tiotropium + olodaterol | Intervention Type: DRUG; Name: tiotropium; Assigned to Arm(s): tiotropium
C: Arm Label: 1; Type: ACTIVE_COMPARATOR; Interventions: Drug: Formoterol plus Placebo (Tiotropium) | Arm Label: 2; Type: EXPERIMENTAL; Interventions: Drug: Formoterol plus Tiotropium | Intervention Type: DRUG; Name: Formoterol plus Placebo (Tiotropium); Assigned to Arm(s): 1 | Intervention Type: DRUG; Name: Formoterol plus Tiotropium; Assigned to Arm(s): 2
D: Arm Label: GFF MDI; Type: EXPERIMENTAL; Interventions: Drug: GFF MDI | Arm Label: GP MDI; Type: EXPERIMENTAL; Interventions: Drug: GP MDI | Arm Label: FF MDI; Type: EXPERIMENTAL; Interventions: Drug: FF MDI | Arm Label: Open-label tiotropium bromide inhalation powder; Type: ACTIVE_COMPARATOR; Interventions: Drug: Open-label tiotropium bromide inhalation powder (Spiriva® Handihaler®) | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo MDI | Intervention Type: DRUG; Name: GFF MDI; Assigned to Arm(s): GFF MDI | Intervention Type: DRUG; Name: GP MDI; Assigned to Arm(s): GP MDI | Intervention Type: DRUG; Name: FF MDI; Assigned to Arm(s): FF MDI | Intervention Type: DRUG; Name: Open-label tiotropium bromide inhalation powder (Spiriva® Handihaler®); Assigned to Arm(s): Open-label tiotropium bromide inhalation powder | Intervention Type: DRUG; Name: Placebo MDI; Assigned to Arm(s): Placebo

Answer: B